This is the first paid-subscriber issue of The Biotech Tea ☕. Starting today, newsletters will alternate between issues that are free for everyone and issues exclusively for paid subscribers.

Let’s get into this week’s cup of biotech tea. ☕ If you only have time for one this week, I’d start with #5!

• A glioblastoma vaccine narrowly misses success, but may still have hope ➡️

• A logic-gated CAR-T therapy for renal cell carcinoma enters the clinic ➡️

• NIH launches new website design focused on streamlining finding info➡️

• FDA announces the Office of Innovation and Clinical Trial Modernization ➡️

• Could cystic fibrosis treatment begin before birth? A family story ➡️

• Biotech Term of the Week: Primary & Secondary Endpoints ➡️

Read more

📌A quick note: Starting next week, The Biotech Tea will alternate weekly between issues that are free for everyone and issues exclusively for paid subscribers. The subscription price will also move to $60/year. If you've been on the fence, subscribing before October 7th at 11:59pm MST permanently locks you in at $30/year. If you missed the announcement email (sent on 9/14), I cover the details and my reasoning! Worth a read prior to the deadline. And lastly, if this is helpful, here is a short email template I drafted to ask work to cover your subscription through professional development budgets.

Subscribe now

Let’s get into this week’s cup of biotech tea. ☕ If you only have time for one this week, I’d start with #1!

• We may see a new wave of osteoporosis drugs on the heels of FDA change ➡️

• Stipple Bio’s Pointillism Platform aims to make epitope-specific cancer drugs ➡️

• Grail’s multi-cancer blood test gets favorable vote in FDA ad-comm meeting ➡️

• A New Approach Methodology (NAM) database is released ➡️

• How U.S. tariffs, effective this week, may be helping China dominate biotech ➡️

1. Story I’m Watching

The Tea: The accepted clinical endpoint for osteoporosis therapies has shifted to something much more achievable - producing a wave of new developments, biotech startups, and investors in the space.

Historically, in order to get approval for an osteoporosis therapy, the FDA required you demonstrate a reduction in bone fracture rate, requiring thousands of patients over several years in order to have enough fractures to support a positive result. In 2013 the Study to Advance BMD (bone mineral density) as a Regulatory Endpoint (SABRE) was initiated. The retrospective analysis pooled data from 52 trials and over 160k participants in order to sufficiently demonstrate that increases in BMD reduce fracture risk. Just last December (2025), the FDA formally accepted the change as a means to traditional approval! I am very interested to see developments for this indication pick up.

A few more sips: As a high-level reminder - bones are constantly remodeling. Osteoblasts are your bone builders and osteoclasts are your bone demolishers. They work together throughout life to maintain proper balance. Certain genetic conditions, and commonly after menopause in women, this balance can be lost resulting in a loss of bone density.

As I was exploring the landscape of osteoporosis drugs, I noticed how the therapy strategy has transitioned overtime from reducing bone resorption to increasing bone formation. See the table below for a bit more information on how this works.

2. From the Bench

The Tea: Stipple Bio, a small startup out of Cambridge, MA, is trying to further optimize cancer therapies by developing drugs that don’t just target cancer-specific antigens but cancer-specific epitopes within antigens.

It’s proven to be a difficult challenge in the field to find antigens that only display on tumor cells; when a drug’s target is also expressed on healthy cells the therapy results in off-target toxicity and unwanted damage to healthy tissue. Stipple’s ‘Pointillist Platform’ is taking the resolution one step further by looking for epitopes, or regions of antigens, that are unique to tumor cells. Data shows that even when a healthy cell may express the same protein as a cancer cell, the DNA template can sometimes lead to small amino acid differences that can be taken advantage of.

A few more sips: STP-100 is their lead candidate and we can expect to see it enter Phase 1 clinical trials next year. While we know very few details about it, we do know it is an antibody-drug conjugate (ADC) and Endpoints News reports they are developing for pancreatic cancer among other tumors. If this is the case, it adds to an expanding landscape for the deadly cancer. Rasonque, developed by Revolution Medicine, is a first in class pancreatic cancer therapy that was just approved by the FDA in August (I happened to be walking alongside Loch Lomond in Scotland and completely oblivious to news at the time).

3. Bio[Tech]

The Tea: Grail’s multi-cancer diagnostic test, named Galleri, was voted safe by the FDA’s Molecular and Clinical Genetics Devices advisory committee this past week. While the conversation consisted of some questions around sensitivity for certain types of cancers, ultimately the adcomm voted 7 to 2 in favor of Galleri’s benefit to risk profile. Until now it was commercially available as a laboratory-developed test under CLIA but if the FDA approves it, it would have the potential to be used more widely. For a concise but helpful look into the nuance of the decision I found this substack post helpful.

A few more sips: We haven’t covered the multi-cancer test in The Tea ☕ yet so I thought it would be useful to quickly cover the premise for how it works.

Galleri is a test that looks for methylation patterns on cell free DNA (cfDNA) fragments present in patient blood samples. The test first treats the cfDNA with bisulfite which converts unmethylated Cs into Us. The samples are then sequenced using next generation sequencing techniques and machine learning algorithms analyze the methylation patterns to determine if the DNA fragment came from a healthy cell or a cancerous one, and which tissue.

4. The Rulebook

The Tea: We know that the FDA is driving motivation for the use of non-animal models in drug applications. In order to provide practical examples of New Approach Methodologies (NAMs), they have released a database that contains links to publicly available application materials. It currently contains 25 examples. Back in April, we covered the newly announced $150M in grants toward the use of NAMs. I updated the graphic to include the release of the new database.

5. The Human Side

The Tea: In this opinion piece, the Wall Street Journal Editorial Board argues that U.S. tariffs on imported drugs and ingredients, announced earlier this year but effective just this week, could ultimately help China in their push to dominate the industry. The piece focuses primarily on the impacts this may have on small biotech companies, which often have few drugs in the pipeline and limited ability to build or secure domestic manufacturing capacity. The authors note that companies encounter much lower costs and less regulation when they look abroad. The piece also discusses how the tariff pressure is pushing companies to strike deals with the government, and how this may impact approvals.

Biotech Term of the Week

Paid Subscriber Bonus Content

📌A quick note: Starting October 8th, The Biotech Tea will alternate weekly between issues that are free for everyone and issues exclusively for paid subscribers. The subscription price will also move to $60/year. If you've been on the fence, subscribing before October 7th at 11:59pm MST permanently locks you in at $30/year. If you missed the announcement email (sent on 9/14), I cover the details and my reasoning! Worth a read prior to the deadline. And lastly, if this is helpful, there is still plenty of time to ask work to cover your subscription through professional development budgets using this short email template I drafted.

Subscribe now

Let’s get into this week’s cup of biotech tea. ☕ If you only have time for one this week, I’d start with #1!

• A look at heparan sulfate as a biomarker for a few rare disease gene therapies ➡️

• Cannabinoid receptor agonist shows weight loss in an obese mouse model ➡️

• An at-home COVID-19 nucleic acid test gets FDA 510(k) approval ➡️

• A look at an FDA report covering complete response rate trends since 2008 ➡️

• Why isn’t there a ‘pregnant or lactating’ filter on ClinicalTrials.gov? ➡️

1. Story I’m Watching

The Tea: Just last week, Ultragenyx received FDA approval for Fayuvi (UX111), an AAV gene therapy for Sanfilippo syndrome type A — a rare inherited metabolic disease in the group of mucopolysaccharidoses (MPS). It is one of a series of MPS-targeting gene therapies that have submitted to the FDA in the last few months using the biomarker heparan sulfate as the clinical trial readout. This stood out to me so I wanted to dive in and give a summary!

Heparan sulfates (HS) are long, sulfated carbohydrate chains found on cell surfaces (usually as part of proteoglycans) that, in a healthy state, are constantly turned over. In diseases that result in certain enzyme deficiencies, such as in MPSs, HS can build up.

Fayuvi of Ultragenyx, Avlayah of Denali, and RGX-121 of RegenxBio, all strategically chose to use HS build up as an endpoint compared to the much more difficult to capture neurodevelopmental clinical measures. As you can see from the table I made below, there have been varying outcomes for MPS trials using HS as the endpoint. Will definitely be watching for HS use in more trials!

2. From the Bench

The Tea: Interesting data in mice just demonstrated that a cannabinoid receptor (CB) agonist may be promising for weight loss. The recently published data showed that Artelo Biosciences’ ART27.13, an oral agonist against both CB1 & CB2, resulted in comparable weight loss to semaglutide on it’s own (20% over 4 weeks), and further, when combined with semaglutide, weight loss doubled (40% over 4 weeks). Importantly, the therapy only resulted in weight-loss in obese mice.

A few more sips: ART27.13 was originally developed and trialed for cancer anorexia-cachexia syndrome. In the Phase 2 CAReS study, patients on the therapy saw a weight gain of around 6% compared to a weight loss of around 5% in placebo.

If you’re a bit confused about how it helps with weight gain in one indication and weight loss in another, you’re not alone. Historically, CB agonism has been thought to increase appetite and therefore increase weight. Two synthetically derived THC-like products, Marinol and Syndros, have been approved by the FDA for chemotherapy associated nausea and treating weight loss from anorexia or in AIDs patients. CB antagonism intuitively would be the opposite. Because ART27.13 is showing weight-loss in obese mice, but not in lean mice, it’s being called a “metabolic regulator”. Results differ depending on the phenotype being treated (lean vs. obese).

Message me if you have a recent science development you’d like to see featured!

3. Bio[Tech]

The Tea: The FDA just granted Aptitude 510(k) clearance for its COVID-19 at-home nucleic acid test that can be run on their Metrix reader device. The product had been operating on emergency use approval (EUA) prior to this. Their COVID-19/Flu combined test is currently under review for 510(k) clearance, and they are developing a test that includes RSV.

Personally, I’m intrigued by at-home nucleic acid-based tests. As they are more sensitive than lateral flow-based tests detecting viral antigen, it seems like a useful option for catching infections early. The Metrix reader is currently showing as $50 on their website, but the bulk of the cost comes from individual tests which cost anywhere from $25-45.

4. The Rulebook

The Tea: The FDA, in response to criticism that there has been an increasing number of early drug application rejections, released a report on complete response rates this past week. It covered NDA and BLA applications through CDER from 2008 to 2024. From the data they present (graph below), you see an overall downward trend.

5. The Human Side

The Tea: If you’ve ever been on the side of searching for a clinical trial for yourself or a loved one, you know about ClinicalTrials.gov. In this opinion piece written by 3 faculty at Brown University, they make the keen observation that there is no way to filter available trials for individuals who are pregnant or lactating. The article walks through a high-level current history of trial participation for this group of people, the progress we’ve seen, and the remaining gaps.

Biotech Term of the Week

Paid Subscriber Bonus Content

We’re back to regular Biotech Tea issues!

📌A quick note: On October 8th, The Biotech Tea shifts to an every-other-week paid model and the subscription price moves to $60/year. If you've been on the fence, subscribing before October 7th at 11:59pm MST permanently locks you in at $30/year. If you missed Monday's email, I cover the details and my reasoning! Worth a read prior to the deadline. And lastly, if this is helpful, there is still plenty of time to ask work to cover your subscription through professional development budgets using this short email template I drafted.

Subscribe now

Let’s get into this week’s cup of biotech tea. ☕ If you only have time for one this week, I’d start with #3!

• Definium achieves another late-stage LSD therapy success for general anxiety ➡️

• Mushroom compound shows promise in reducing chemotherapy neuropathy ➡️

• Echocardiograms in space give insight into Mars mission preparation ➡️

• FDA TrialBlazer pilot applications open for biopharma sponsors ➡️

• Elisabeth Marnik, a prominent scicommer, grew up in an anti-vaccine home ➡️

1. Story I’m Watching

The Tea: A late-stage, 12-week trial, of DT120 — an LSD therapy developed by Definium Therapeutics — saw a significant reduction in anxiety compared to placebo. In trial Panorama, the Hamilton Anxiety Rating was the primary indicator measuring anxiety and those on DT120 saw a 9.8 point drop on the scale compared to 4.7 point drop experienced by placebo. This is a confirmatory late-stage trial that shows comparable results to the first late-stage trial, Voyage.

A few more sips: This is Definium’s 4th trial looking at LSD DT120 for either anxiety (generalized anxiety disorder, GAD) or depression (major depressive disorder, MDD). In the space of psychiatrics, it’s common to submit for regulatory approval with two separate late-stage trials that show success.

2. From the Bench

The Tea: On the psychedelic train… early mouse data from MD Anderson shows the potential of mushroom compound, psilocybin, in treating chemotherapy induced peripheral neuropathy (CIPN). Patients can experience limb sensitivity, numbness, or tingling for weeks to years after certain platinum-based chemotherapies as a result of injury to sensory nerves and other physiologic or cellular changes (including mitochondria dysregulation).

Psilocybin, found in mushrooms, was hypothesized to have protective effects if given prior to chemotherapy. Researchers found that in mouse models, few pre-therapy doses were needed in order to successfully reduce nerve hypersensitivity.

A few more sips: Psilocybin is a prodrug that, once converted to Psilocin, acts as a serotonin 5-HT2A receptor agonist. To better understand the mechanism, here is the abstract and description from the publication.

Message me if you have a recent science development you’d like to see featured!

3. Bio[Tech]

The Tea: With the help of Earth-side sonographers, 13 astronauts were able to do regular echocardiograms on themselves in space to contribute to important data on how the heart responds to prolonged exposure (6 months) to microgravity. Until the recently published data in Circulation, cardiovascular health and space had more limited information; but in preparation for the (currently slotted) 2035 Mars mission, NASA wants to better understand what precautions or measures may need to be taken for the health and safety of the crew. Ultimately, they discovered that while there were changes early in the space time, by the end of the 6 months, most values had stabilized, and changes were not outside the range of normal for humans on earth.

A few more sips:

Important to understanding the results, the measures of our hemodynamics shift on earth even between supine positioning (lying-flat) and upright (standing).

Early flight values (first 14 days) for measures such as left ventricular end-diastolic volume and stroke volume decreased compared to lie-flat values on earth; however, they were actually pretty similar to standing values on earth. Even with that change, by the end of the six months, the values had stabilized and were again closer to the lie-flat earth values. The final part of the study was evaluating how the crew member’s hearts reacted to Mars gravity (which is roughly 3/8 of Earth’s) after the 6 months, which is roughly the mission time it would take to reach the red planet. There was noticeable change, but again only around the values of standing position on earth.

4. The Rulebook

The Tea: This summer the FDA announced the pilot program TrialBlazer — another initiative to try and move the FDA review process along quicker. Just this week the application — to be one of the 10 early guinea-pigs of the program — opened.

TrialBlazer aims to pair industry sponsors with qualified research institutions (QRIs) in order to both aid in the more efficient development of a quality IND application and partially review them. The FDA will then be able to review portions of the application on a rolling basis, knowing that they have already been looked over by a QRI.

A few more sips: The new FDA CBER Director, Karim Mikhail, has stated that the QRI umbrella is purposely large. The idea is for the sponsor to select the most appropriate consultant to fit the job. When it comes to conflict of interest (COI), Mikhail states that the FDA is still doing all the final review, so that should be of low concern. I think it will be interesting to see how much review is QRI vs FDA. In order to effectively save time, you’d imagine that the QRI would do some heavy lifting, in which case COI does matter.

5. The Human Side

The Tea: A good friend and colleague had a bio written about her in STAT last month and I wanted to have a chance to cover it! , director of The Evidence Collective and Chief Scientific Officer of Those Nerdy Girls, grew up in a strict Evangelical Christian home that was anti-vaccine. She is now an avid science communicator who advocates for empathy, above all else. In this article you are able to see how her past dramatically shaped how she approaches vaccine advocacy and public health work. If you’re on the fence about how to approach conversations with those who are hesitant or against modern day public health initiatives, I think reading her perspective is of value.

A few more sips: Liz is a dear friend and just walked the West Highland Way with me! I first met her in 2021 doing science communication on social media and I now work with her at The Evidence Collective.

Biotech Term of the Week

A quick note before we begin: I’m currently on sabbatical and just completed driving the perimeter of stunning mainland Iceland with my husband. While planning this trip, I wanted to find a way to keep sharing something with you each week while being able to leave my laptop thousands of miles away at home. As such, I prepared two special edition pieces inspired by places I’d be visiting. Last week was Biotech in Scotland, if you missed it! The Biotech Tea ☕ newsletter format will return next week. I hope you enjoy!

Subscribe now

In the last few years, I bet you can name at least one friend or family member that’s visited Iceland. It’s known to many as “The Land of Fire and Ice” as it contains both active lava flows and arctic glaciers. Its absolutely stunning landscapes (black sand beaches, rainbow rhyolite mountains, geometric rock formations, & natural hot springs just to name a few), feel almost otherworldly and attract tourists from all over the world.

The Ring Road (which I just finished driving!) is the name of the ~800 mile stretch of pavement (well 98% paved) that takes you around the entire country. Reykjavik, the capital, which holds over a third of the country’s population, is on the Southwestern side of the island. With less than 400,000 citizens, it’s Europe’s most sparsely populated country.

So, what does biotech look like in Iceland? As you can imagine, being so remote, it’s a smaller biotech ecosystem, but still rich in history. While the country has 7 public or private universities, the country’s oldest and most established university, the University of Iceland has the largest biotechnology opportunities. It runs an Applied Biotechnology Master’s program as well as a Doctorate in Bioengineering.

Let’s take a look at some of the highlights in biotech as I learned more about it!

deCode genetics, is harnessing population genetics to advance gene discovery.

One of the most interesting things I learned when researching the country is that nearly HALF of the population has volunteered to provide a DNA sample and medical record information to take part in gene discovery and population genetics work. The effort was led by deCODE Genetics, founded by Kari Stefansson in 1996. While it has since been acquired by Amgen, it is still going strong with the goal of using population-scale genetic information to better understand disease risk factors and advance precision therapeutics.

Most recently, and published in Nature Medicine, the work of deCode has contributed to better understanding the genetic risk factors associated with fibromyalgia.

The acquisition by Amgen has led to a fruitful relationship where the genome sequencing and analysis strengths of deCode can be combined with acquired Amgen clinical trial data.

Kerecis, since acquired by Coloplast, harnesses the wound healing potential of Icelandic fish skin!

At Kerecis, fish skin from wild Atlantic cod in Iceland (a sustainable fish stock), is transformed into wound care material! The idea behind their work is to provide a minimally processed graft (less damage or denaturation) that retains as much of the original molecular organization, mechanical properties, and 3-D structure of the original skin as possible. But why cod? Two reasons! One, there is no known viral transmission risk to humans, and two, the molecular structure and thickness of their skin is actually quite similar to humans — with an epidermis and underlying dermis that contain many of the same cell types.

In April of this year, they presented data at the American Burn Association Annual Meeting showing that burn patients who were treated with the fish-skin product as opposed to cross-linked collagen and synthetic polyurethane had significantly shorter hospital stays and 5% points less graft loss. This is just one of the many applications in their pipeline.

Robert Wessman, founder of biosimilar development giant, Alvotech, has also helped Fruman, Iceland’s first biotechnology incubator, get off the ground.

Robert Wessman is a prolific biotech influence in Iceland. Over his lifetime he has led several biotech companies, including Alvotech. Started in 2013, Alvotech’s sole mission is to effectively deliver biosimilars (biologic generics) to the global market. It has end-to-end capabilities from cell line development to manufacturing.

The Fruman (‘cell’ in Icelandic) biotechnology center, centered in Reykjavik and launched just recently in 2025, started with significant backing from Wessman and is closely tied to Alvotech’s footprint and technology. It speaks to Wessman’s desire to nurture Iceland’s biotech impact. Fruman is built with 4 pillars:

• Fruman innovation center - a space for accelerating entrepreneurial biotech ideas

• Fruman lab - a fully equipped research facilities available for rent

• Fruman academy - the education and skills development pillar

• Fruman biotechnology fund - investment fund to help support & sustain ideas

So, to end…

While Iceland is small in population and remote in location, it has an increasingly impactful biotech industry — building heavily off willing citizens, unique terrain, and talented scientists.

A quick note before we begin: I’m currently on sabbatical and just completed walking the beautiful West Highland Way with some wonderful girlfriends. While planning this trip, I wanted to find a way to keep sharing something with you each week while being able to leave my laptop thousands of miles away at home. As such, I prepared two special edition pieces inspired by places I’d be visiting. Regular issues of The Biotech Tea ☕ will return in two weeks, on September 17. I hope you enjoy!

Subscribe now

Scotland, oh, Scotland! This beautiful country is the most northern part of Great Britain. The capital is Edinburgh, the heart of Scotland, and it’s where you can find the historic and stunning Edinburgh Castle.

Just about 30 minutes West is the country’s largest city and industrial hub, Glasgow.

Within each of these are two biotech research hubs — the University of Edinburgh and The University of Glasgow. While we don’t always think about Scotland as a biotech powerhouse (or at least admittedly I don’t), it has both a history and current day presence very much worth acknowledging.

Early Biotech Legacy

We’ll start Scotland’s biotech history with the legacy of Dolly the Sheep. I don’t think I realized that Dolly, one of the first successful animal clone experiments, was born at the Roslin Institute just outside Edinburgh.

Dolly, born in 1996, was so important because it demonstrated that all the information needed to make an entire sheep was still inside a fully differentiated adult sheep cell (outlined in blue below). The nucleus from an adult sheep mammary gland cell was combined with a egg cell from a donor sheep. A surrogate sheep carried the resulting embryo, which, after full gestation, resulted in Dolly.

Dolly died of lung disease after living at the Roslin Institute for almost 7 years and giving birth to six lambs, including Bonnie. Analysis suggests nothing about her unusual beginning of life lead to her death. Her life, and the years of work done at the Roslin Institute, opened up the field of regenerative medicine!

The Roslin Institute, to this day, is dedicated to sustainable agriculture through innovative animal bioscience.

Current Biotech Landscape

Dolly might be one of the earliest legacies, but there are many current day innovative biotech companies that have their headquarters in Scotland. Let’s cover a handful of them!

MiAlgae is harnessing the Scottish whiskey industry (how cool?!) to reduce our reliance on marine animals for Omega-3s.

Founder and CEO Douglas Martin started the company in 2016 to help take strain off our oceans. By taking distillery byproducts and feeding them to their proprietary microalgea, they are able to create a DHA (a specific Omega-3) enriched product. In it’s powderized form it can easily be added into animal feed, making a sizeable portion of the market no longer reliant on ocean fish. Their technology won them a spot as a finalist in the 2024 Earthshot Prize competition.

Resolution Therapeutics is clinical-stage company trying to solve inflammatory and fibrotic diseases using regenerative macrophage therapy.

Last year the macrophage therapy space achieved a big milestone with the announcement of positive data from the MATCH trial, out of the University of Edinburgh. This Phase 2 trial was testing a non-engineered regenerative macrophage therapy (RMT) for liver cirrhosis and showed no safety concerns and prolonged survival compared with standard care.

Resolution Therapeutics is moving with that momentum as they continue collecting data in their early Phase 1/2 clinical trial looking at their engineered RMT, RTX001, for end-stage liver disease.

What is the basis of the science? Macrophages, put very simply, have an pro-inflammatory state and an anti-inflammatory state. RTX001 is engineered to continuously self-produce IL-10 and MMP9 which act to lock in and support the macrophages more regenerative functions. By introducing these engineered macrophages into livers already heavily damaged liver tissue, tissue remodeling can be advanced.

Ingenza is a biotech contract research, development, & manufacturing organization (CRDMO) focused on solving manufacturing challenges.

This company contracts to do it all! They take on projects ranging from cell line development to manufacturing for both biologics and small molecule therapies. Established in 2003, they have built out what they called their ‘InGenius’ platform which is made up of many proprietary technologies that they believe gives them an edge when helping streamline drug development.

One such technology is codABLE — an AI-driven DNA optimization technology aimed at maximizing recombinant protein production. Each amino acid in a protein chain can be signaled by a few different 3-letter base pair sequences (known as codons) but some are present in the production cell in higher quanitites than others (or will be incorporated with higher frequences). Codon optimization is the strategic selection of each codon with this information. Ingenza claims their codABLE technology outperforms other leading protein production technologies.

So to end…

Just like with most places unfamiliar to us, Scotland often gets a very two-dimensional take — magnificent castles nestled amongst heather-lined lochs & the warmth of Whiskey loving Scots (both true). But I hope today we have made it more three-dimensional! Scotland is the home of a rich biotech landscape.

Willing to answer 3 quick multi-choice questions so I can get to know you better?

Answer 3 quick questions for me!

Let’s get into this week’s cup of biotech tea. ☕ If you only have time for one this week, I’d start with #1!

• A fridge-free tetanus-diphtheria vaccine just showed safety-efficacy success➡️

• A triple combination therapy that may show HIV promise ➡️

• Samsung Galaxy Buds have an FDA cleared hearing aid feature ➡️

• Proposed updates to the Prescription Drug and User Fees Act ➡️

• Token tax? Investment firm executives implore AI policy action ➡️

• Bonus (paid): Lyophilization ➡️

1. Story I’m Watching

The Tea: Stablepharma, a UK-based biotech company, has developed the StablevaX technology — a shelf-stable drug formulation that eliminates the need for a fridge!

Cold temp storage is a major limitation of improved global vaccine access. Continuous chilling is difficult and expensive in remote, underdeveloped, or far-from-manufacturing locations. Similarly, having something stay stable for years at higher temps reduces vials that have to be tossed.

StablevaX recently showed great success in a Phase 1 trial testing a temperature-stabilized tetanus-diphtheria (Td) vaccine — SPVX02 — compared to two already approved Td vaccines. While in the trial they just tested safety and efficacy, separately SPVX02 has demonstrated that it retains its potency for at least 2 years stored at 30°C! It’s currently under testing to evaluate if it can extend to 4 years.

A few more sips: The StablevaX technology is proprietary but based on the use of trehalose, a disaccharide sugar. Researchers were inspired by the Resurrection plant and its ability to bounce back after periods of serious drought.

A wide variety of pre-existing therapeutics (vaccines, virus-like particles, inactivated pathogens, peptides, small molecules) could potentially be reformulated in order to reduce fridge dependency.

2. From the Bench

The Tea: CytoDin’s leronlimab, which they’ve been evaluating for HIV treatment for years, has shown promise when used as part of a combination therapy in non-human primate studies. In HIV-infected infant macaques neither leronlimab alone (which is a CCR5-inhibitor) nor antiretroviral therapy (ART) + broadly neutralizing antibodies (bNAbs) showed any positive effect. However, when leronlimab + ART + bNabs were given together, viral RNA copies were reduced to undetectable levels and remained that way for months (even after stopping treatment).

In the image below the black graphs indicate the controls monkeys where you can see high and persistent viral RNA in the blood. The blue graphs are the monkeys that got ART and bNAbs but no leronlimab. In this case you see a reduction in viral RNA in the blood but it rebounds when treatment stopped. Finally, the red lines are with all 3 therapies and you see a reduction in viral RNA that lasts.

A few more sips: CytoDin has a fraught recent history, dating back to early 2020. It’s then-CEO, Nadar Pourhassan, made a series of fraudulent announcements that eventually lead to his ousting by the board 1.5 years later. First, in 2020, he said a BLA had been submitted to the FDA for one of their drug candidates, but that wasn’t true. Next, they tried and failed to pivot leronlimab toward COVID-19 but, despite the disappointing data, Pourhassan still significantly oversold the results. In May of 2021 the FDA publicly rebuked CytoDyn and they were also served multiple subpoenas. In 2024 Pourhassan was convicted on 9 counts, sentences to 30 months in prison, and fined millions of dollars. Through all of this, HIV trials for leronlimab were dirtied and they withdrew their application for approval.

Message me if you have a recent science development you’d like to see featured!

3. Bio[Tech]

The Tea: Samsung’s Galaxy Buds (3 and 4 Pro) have a hearing aid feature that was just cleared by the FDA! Anyone with a pair of the earbuds can enter the app and perform a hearing test. The 5 minute audiometry test, which identifies which frequencies may be harder to hear and to what degree, results in a person-specific sound amplification profile to improve hearing. If you are more in-the-know on hearing aid tech, it uses a standard NAL-NL2 algorithm in the software to calculate adjustments based on the audiogram results. Talk about making health tech accessible! I’ll definitely be looking into this for someone I know.

4. The Rulebook

The Tea: The FDA released its proposed Prescription Drug User Fee Act (PDUFA) update for 2028-2032. As a reminder, PDUFA is the framework that sets the rules between companies and the FDA when it comes to application fees and review timelines.

A handful of the proposed changes are in line with this administrations interest in incentivizing domestic drug development. One of the proposed changes is a 50% fee reduction if it includes data from a Phase 1 trial anchored in the U.S. (initiated after Oct 1, 2027). Another proposes updating the small-business waiver to only apply for domestic companies. There has even been talk that the fee itself will be different depending on if the sponsor is domestic or foreign (but no specific mention of that in the commitment letter).

A public meeting will be held on September 16th to discuss the proposed updates, and public comment can be submitted until September 2nd!

5. The Human Side

The Tea: In this NYT piece, Greg Jensen and Nir Bar Dea, CIO and CEO of investment firm Bridgewater Associates, wrote about how important AI policy is right now. Bridgewater has believed in AI for years (and can back that up with serious investment history), but, even at their own short-term expense, they are imploring policymakers to make efforts that ensure that even with AI tech we 1) protect human labor and 2) work to make AI equitable. Much of the conversation circles around token tax policy.

“We may have only one shot at taking meaningful action. And though these steps may rattle equity markets and firms like ours that stand to gain from uninterrupted growth in A.I., not taking them and waiting for more societal damage or a catastrophe is more dangerous.”

Biotech Term of the Week

Paid Subscriber Bonus Content

Lyophilization

🗣️This week’s issue is in the usual format but with a slightly different flavor! How come? I spent Monday through Thursday of last week attending the 2026 Bioprocessing Summit and wanted to cover some of the highlights in this week’s newsletter!

A fun perk of attending virtually is that you can jump around from ‘room’ to ‘room’ throughout the day, catching anything that seems most interesting. And while there is a lot of diversity in the talks I chose (AAV gene therapy, ADCs, cell therapy, formulation optimization, digital twins, etc.), the general throughline is strategies and technologies being explored to better advance the development of complex therapeutics. Or maybe more fun: “Innovation & AI meets stubborn molecules”.

Let’s get into this week’s cup of biotech tea. ☕ If you only have time for one this week, I’d start with #5!

• GeneData, a digital AI ecosystem for bioprocessing co-developed by Novartis ➡️

• A new generation of masked antibody-drug-conjugates, developed by Byondis ➡️

• BioCurie, in collab with MIT, found a way to capture real-time rAAV titers ➡️

• Topic 4 ➡️

• Engineering your workforce to be ready to adopt digital tools and AI ➡️

• Bonus (paid): Drug-to-Antibody Ratio ➡️

1. Story I’m Watching

The Tea: We all know that AI is making its way into biotech, but most companies still vary on to what degree and how. In the last year I have sat in multiple demonstrations of digital AI ecosystems that are meant to integrate end-to-end (E2E) in bioprocessing. GeneData, co-developed with Novartis, is one such ecosystem that presented at the conference this week. The system actually won an Innovation Practices award at Bio IT World in May of this year!

While they have several products, the bioprocessing arm of GeneData is focused on pulling raw data from instruments and acting as an all-in-one system for data processing, modeling, reporting, searching, and interacting with via a built-in agent. Below is an example of the system working for cell line development and clone selection. Real-time bioreactor data can be combined with company historical data to make decisions.

Another such digital tool for bioprocessing that I’ve seen demonstrated is InvertBio.

To me, this feels like such a good way to use AI. Data runs deep in biotech companies, and having digital AI tools to help collect, manage, and interpret, could save significant time.

2. From the Bench

The Tea: Byondis, a small biotech in the Netherlands, has developed a dual-activatable ADC meant to help reduce off-target healthy cell toxicity even more effectively than traditional masking designs.

FYI: We’ve talked about activatable antibodies before (CytomX’s ADC for colorectral cancer).

Byondis noted that with the traditional design — a single protease-cleavable linker and a binding-domain blocking molecule — sometimes, even after cleavage of the linker, the blocking molecule can remain bound strictly off of affinity! They came up with a design aimed to eliminate this risk — ByonGuard. By creating a blocker that doesn’t directly bind to the antibody but hovers close enough to it to sterically block target binding, after cleavage, there is no risk of it remaining in the way.

In the talk I attended, Dr. Danielle van Wiljk, Principal Scientist at Byondis, went over both in vitro and in vivo data that demonstrated a great on-target therapeutic index while also showing reduced toxicity in healthy tissue. They presented proof-of-concept data with a tissue factor (TF) targeting ADC.

A few more sips: Beyond the design, Dr. van Wiljk went over how important it was for them to carefully review the new vulnerabilities of the molecule during the production process. They did many design of experiment (DoE) projects to look at high-molecular weight (HMW) species in their product in response to changes in protein concentration, pH, time, histidine, and salt concentration. The results informed changes in their typical mAb manufacturing process and final formulation that greatly improved stability.

Message me if you have a recent science development you’d like to see featured!

3. Bio[Tech]

The Tea: Researchers with BioCurie, in partnership with MIT chemical engineering, have demonstrated that size, mass, and density data collected from a single-cell suspended microchannel resonator, paired with a trained machine learning model, produces comparable rAAV titers to gold standard ddPCR or ELISA methods.

Dr. Farncesco Destro, Head of Engineering at BioCurie Inc., presented data on the real-time at-line device for measuring rAAV titer. Gold standard methods for assessing rAAV titer are discreet and laborious — you have to sample your bioreactors at specific time points of interest and run them in either ELISA or ddPCR-based methods to get results. This often takes a few days. By using a microchannel system to measure titer, information about rAAV productivity can be assessed every 10 minutes!

BioCurie is an biotech AI company with the goal of using their predictive modeling software to optimize the production process for a variety of complex biotherapeutics. Just earlier this year they received $9.3M from ARPA-H to optimize gene therapy manufacturing.

4. The Rulebook

The Tea: So, we’ve heard about digital twins for things like manufacturing (we coined them “manufacturing SIMS” in issue No. 3), but what about for more regulatory-centered tasks? Dr. Sri Narayanan, interestingly a dentist by training but now an expert in biopharma AI & modeling, demonstrated the use of digital twin technology for deviation investigations. For example, what if a batch shows an unexpected dip in yield mid-process? The digital twin monitoring system, which is continuously comparing live sensor data against the expected process model and historical batch data, can flag the anomaly much quicker than a manual process. It can alert a scientist who may have the opportunity to intervene and save the batch.

A few more sips: One of the speakers showed this helpful diagram from USP and I thought I’d share it here. It helps differentiate models, shadows, twins, and cognitive twins!

5. The Human Side

The Tea: Dr. Jason Beckwith, Senior VP at Biotalent, gave a fascinating talk on the criticality of continuing to develop an AI-enabled workforce in order to sustain technology adoption. He emphasizes that while advanced tools help optimize bioprocesses, a digitally skilled workforce is what determines if it is successful.

Biotalent, is a consulting company based on measuring ‘Talent Science’ and helping with ‘Workforce Engineering’. Dr. Beckwith has written a white paper on workforce engineering where he goes into quite a bit of detail on this, including a ‘workforce capability function’ that encourages employers to regularly quantify capability density (CD), skills adaptability (SA), success resilience (SR), and workforce alignment (WA).

Biotech Term of the Week

Paid Subscriber Bonus Content

Drug-to-Antibody Ratio (DAR)

🗣️ Stay tuned! I’m attending the Bioprocessing Summit this week, so next week’s issue will be a special conference-themed edition. Same structure, but sections pulled from talks I attended!

Let’s get into this week’s cup of biotech tea. ☕ If you only have time for one this week, I’d start with #2!

• The FDA has approved Moderna’s 4th mRNA-based vaccine, this time for Flu! ➡️

• Fungi help discover a new immunosuppressant for organ transplantation ➡️

• To keep up with the scale of the Cyclospora outbreak, Roche adds tests ➡️

• Dr. Erica Schwartz has been confirmed our new CDC Director ➡️

• A reflection piece as we hit one year since the shooting at CDC headquarters ➡️

• Bonus (paid): Restricted Stock Unit ➡️

1. Story I’m Watching

The Tea: A few weeks back we covered the FDA advisory committee recommending Moderna’s mRNA-based flu vaccine in 50+, but we were still waiting on the FDA’s decision. Well just last week the FDA announced its approval of the product! It’s Moderna’s 4th FDA approved product.

As of right now, there has been very little talk about availability timelines. Normally the upcoming flu vaccine is rolled out early August, so I would anticipate seeing it available in the coming weeks.

A few more sips: As a reminder, mFlusiva is an mRNA-based vaccine similar to that of the Moderna and Pfizer COVID-19 vaccines. A lipid nanoparticle encapsulates three mRNAs that each encode for the hemagglutinin (HA) glycoproteins of influenza A-H1N1, A-H3N2, and B-Victoria. The Phase 3 trial data was published in NEJM earlier this year and showed that the the mRNA-based vaccine reduced the risk of influenza-like illness by 26.6% relative to the standard-dose vaccine it was compared to! This bump in efficacy combined with the added technology benefit of quicker seasonal pivots, may be a game changer for protecting against seasonal strains.

2. From the Bench

The Tea: LifeMine Therapeutics, a Cambridge Massachusetts biotech company that centers around what we can learn from Fungi, just raised $263M to accelerate their novel calcineurin activation inhibitor — LIFE-001.

They have a unique top-down approach to designing medicines that centers on learning from the evolution of fungal genomes! They have built out the largest collection of deep-sequenced fungi species that helps them digitally search for genetically encoded small molecules (GEMs) that could be new human drug candidates. That works because fungi are relatively close to humans evolutionarily!

Calcineurin activation inhibitors (CNais) are a type of immunosuppressants and work by blocking cytokine production (via NFAT dephosphorylation) stopping the activation of T-cells. This class of drug is largely used in organ transplants to avoid rejection, but also for things like psoriasis, arthritis, etc. LIFE-001 is recruiting for a Phase 1 kidney transplant and islet cell transplant study that aims to begin next year.

A few more sips: LifeMine’s CNai is unique from those already on the market (like Cyclosporin A) because it directly targets and binds calcineurin as opposed to targeting intermediary pathway proteins (like cyclophilin A).

Message me if you have a recent science development you’d like to see featured!

3. Bio[Tech]

The Tea: While the iceberg lettuce cyclosporiasis outbreak continues to expand, Roche is adding two additional Cyclospora tests to the landscape! As of this week, there are more than six thousand cases across 15 states. Additionally, there have been nearly 300 hospitalizations and 2 associated deaths.

As a reminder, molecular-based gastrointestinal (GI) screening tests are very sensitive and have the ability to detect multiple targets at once. Hospitals that receive patient stool samples either send them out to a certified lab for the test to be run, or run them in-house if they’ve adopted the technology. There are a handful of approved PCR tests that detect the presence of select bacteria, viruses, or parasites that could be the culprit when a patient comes in with GI symptoms.

The two qPCR Roche tests are designed for research use only (RUO). Despite this, adding new options to keep up with the surge is helpful.

• LightMix Modular Cyclospora (detects only Cyclospora)

• LightMix OneTube Gastro Para 2 (panel including Cyclospora)

A few more sips: Last month we covered other FDA approved and LDT Cyclospora diagnostic tests.

4. The Rulebook

The Tea: Dr. Erica Schwartz has officially been confirmed CDC Director. It’s been fascinating to watch the peaks and troughs of her support ever since the President announced her nomination in April. Largely in line with party counts, she confirmed in the Senate with a vote of 51-44. Senator Cassidy, a career physician, is one Republican Senator who initially indicated he may not support Schwartz, but in the days leading up to the confirmation, changed his position.

As a reminder, she has three degrees (a BS in Biomedical Engineering, an MS in Public Health, and an MD) and decades of relevant professional experience. She once served as Deputy Surgeon General and held several positions within the U.S. Coast Guard, including Chief Medical Officer and Chief of Preventative Medicine. Since her nomination she has been unclear on her alignment with Secretary Kennedy, making her more appealing to some, and less to others.

5. The Human Side

The Tea: It was just over a year ago that bullets were shot at windows of the CDC headquarters in Atlanta. In this personal reflection piece, Daniel Jernigan (former director of the National Center for Emerging and Zoonotic Infectious Diseases) describes that scary day and how it’s felt since.

“Public health workers protect everyone from outbreaks. Now the same people need protection.”

Biotech Term of the Week

Paid Subscriber Bonus Content

Restricted Stock Unit

☕ Welcome to The Biotech Tea, ! I have a goal of expanding my corner of the internet to 1000 in just a few weeks so if you find this a helpful resource, hit the subscribe button. You’ll get a quick weekly summary every Thursday morning!

Subscribe now

Let’s get into this week’s cup of biotech tea. ☕ If you only have time for one this week, I’d start with #1!

• Poor ethics and even worse accountability in a gene editing experiment ➡️

• ‘Doggybone DNA’ vaccine used in first lung cancer patient ➡️

• J&J gets De Novo approval for a soft-tissue surgery robot — OTTAVA ➡️

• Online prediction markets enter the drug trial and approval space ➡️

• NSF introduces new industry-academic PhD pilot program ➡️

• Bonus (paid): De Novo Authorization ➡️

1. Story I’m Watching

The Tea: The awful outcome of an extremely poor bioethics decision in gene editing is making the rounds in the media the last few weeks. A six-year-old girl from China, named Mei, died from an experimental gene editing therapy for a minor developmental delay caused by Snijders Blok-Campeau syndrome.

A single base pair mutation in the CHD3 gene was the disease culprit and a neuroscientist, Dr. Zilong Qiu, felt confident he could fix the mutation with an AAV-delivered base editor. To make a long story short, he and his research team failed to clearly explain the risks seen in the non-human primate studies. The severe kidney and liver damage seen in the monkey’s were downplayed to Mei’s parents when they signed her up for the treatment. Within days, Mei reacted poorly to the therapy and had died of suspected immune reaction. To make the story worse, the researchers went on to publish their research without mentioning her death. Her story is just going public after her parents decided the story was important to tell.

A few more sips: For timeline context this was all happening around the same time as the miracle story of ‘Baby KJ’ being successfully treated for his rare metabolic disorder with personalized CRISPR gene editing.

We covered Baby KJ and some of the most recent gene editing publications by the research group at Children’s Hospital of Philadelphia in Issue #5!

2. From the Bench

The Tea: In the UK, a patient received the first of it’s kind ‘doggybone DNA vaccine’ — NEOVACC — for personalized treatment of her PD-L1 non-small cell lung cancer. The DNA-based vaccine is made to target patient-specific neoantigens (tumor antigens that are not native to the patients healthy cells) and be combined with a more standard immunotherapy, like Keytruda.

The doggybone DNA (dbDNA) technology is developed by Touchlight. It is a cell-free production process that forms covalently closed linear DNA vectors that they claim are still high performing in cells, much faster to produce than plasmid DNA in bacteria, and more pure. It uses a polymerase and protelomerase duo to amplify and then transform the template DNA (which encodes for the neoantigens) into the dbDNA morphology. DNA production timelines can be a serious bottleneck in manufacturing and Touchlight aims to address that.

A few more sips: NEOVACC is delivered intramuscularly via a needle-free jet injector! The PharmaJet Stratis device uses spring-loaded pressurization and a microscopic tip to force the liquid drug formulation through the surface of the skin into the muscle.

A special thanks to a reader (and good friend) for sending me the article on this one!

3. Bio[Tech]

The Tea: Johnson & Johnson has just received FDA De Novo authorization for it’s new soft-tissue robotic surgical system known as OTTAVA. It’s indicated for use in a handful of procedures including gastric bypass, splenectomy, small bowel resection, and appendectomy, just to name a few. De Novo authorization indicates that it was different enough from it’s (well known) predecessor — Intuitive Surgical’s da Vinci robot — to warrant a new “category”.

So what are the stand-out features of OTTAVA? Probably most notably is that the 4 robotic arms are not carted into the OR next to the patient (as da Vinci is) but they are actually integrated into the surgical table! The table itself is also able to move in tandem with the arms to help ensure patient-robot positioning is optimal (they call this twin motion).

4. The Rulebook

The Tea: You may have heard of the online prediction markets Kalshi or Polymarket. They let you bet on almost anything in real-time — sports, elections, weather, politics, etc. Well now it’s expanding to include bets on drug trials and regulatory approvals, which is causing quite the stir.

You have to ask yourself what kinds of decisions a researcher, physician, or patient may make if monitoring betting results of clinical trial.

“Turning loose a betting market in an ongoing randomized clinical trial really is a breach of scientific conduct.” - Dr. Robert Califf, former FDA commissioner

But Kalshi argues that odds for the success of a new therapy is one of the most valuable numbers in the economy and that improving visibility can only be beneficial, even if disruptive in the short-term.

I’m curious for those of you who work in biotech or pharma:

5. The Human Side

The Tea: The NSF just announced a new $47 million pilot program aimed at funding 250 PhDs that combine both academic and industry experience. The Industry-Integrated PhD (I-PhD) Scholars Program aims to graduate selected students from their university graduate program in just 4 years, with heavily industry-informed dissertation work. The first year will be funded by the university, while years 2 through 4 will be funded by NSF and the industry partner. Companies are required to contribute at least $100k per student which definitely shifts the model of how graduate research is funded.

Biotech Term of the Week

Paid Subscriber Bonus Content

De Novo Authorization

Framework for FDA Encouraging Innovation

When I sat down and looked at the gathered list of FDA incentives, it felt most helpful to group them by function. What phase of the drug development cycle does it most play a role in advancing? What bottleneck in development is it designed to help address? I named the following five categories:

• Advancing Research

• Faster Development

• Regulatory Flexibility

• Faster Review

• Economic Incentives

Below is a table putting the various FDA programs into each of the categories. Continue reading to find a comprehensive summary.

Read more

🆕 For those who are new here, The Biotech Tea is meant to be a well-rounded, useful, but never overwhelming resource.

Each week you’ll always see the same sections:

1) Story I’m Watching - a highlight

2) The Bench - a science discovery

3) Bio[Tech] - a tech advancement

4) The Rulebook - a regulatory shift

5) The Human Side - a perspective

And for paid subscribers, each issue ends with the Biotech Term of the Week to improve your understanding and expand your confidence.

Let’s get into this week’s cup of biotech tea. ☕ If you only have time for one this week, I’d start with #3!

• Six new peptides recommended by PCAC to be allowed to be manufactured ➡️

• A GLP-1/glucagon dual agonist shows promise in reducing alcohol drinking ➡️

• A “cochlear implant for blindness” is approved in the EU for vision loss ➡️

• In a reversal, Sen Cassidy expresses support of Schwartz for CDC Director ➡️

• Tips & tricks for making a graphical abstract with AI - and my thoughts on it! ➡️

• Bonus (paid): Summary of FDA Encouraging Innovation series on Monday! ➡️

1. Story I’m Watching

The Tea: Last week the Pharmacy Compounding Advisory Committee (PCAC) voted to allow the manufacturing of several peptides that have been on a ban list for years.

Six of the 7 peptides on the docket were given the green light by PCAC, but now the FDA has to make the final call on whether to lift the restrictions. Emideltide was the only one rejected. It’s important to remember that none of these are FDA approved, meaning we don’t have solid human safety or efficacy data.

A few more sips: A few weeks back we covered that the panel was stacked with new members just in time for the meeting.

2. From the Bench

The Tea: Altimmune’s GLP-1 & glucagon agonist demonstrated a reduction in drinking in individuals with alcohol use disorder in their Phase 2 RECLAIM trial.

Pemvidutide is a once-weekly dual agonist injection peptide. Excitingly, trial participants on pemvidutide had, over a 24-week period, 4.2 fewer heavy drinking days per week compared to placebo. The number of no-alcohol days also decreased.

The peptide can bind to both glucagon receptor and GLP-1 receptor. Their ‘EuPort’ domain that decorates the peptide, is designed to prolong serum half-life, extending time between doses.

A few more sips: This dual agonist injection has also separately been evaluated for two other indications. Their furthest along indication is fatty liver disease. It was granted FDA Breakthrough Therapy Designation in January of this year based on some of their Phase 2b data (IMPACT). There have also completed early trials (MOMENTUM - Phase 2, 2023) for the more common indication of a GLP-1 agonist — weight loss. However, it appears that it has been deprioritized over liver-centric indications.

Message me if you have a recent science development you’d like to see featured!

3. Bio[Tech]

The Tea: Science Corporation just achieved EU approval of their “cochlear implant for blindness” — PRIMA — for age-related macular degeneration (AMD).

The retinal implant technology was developed to help restore some central vision for people suffering from vision loss associated with AMD. It is being evaluated for other eye diseases but is only approved (and only in the EU) for AMD.

The system is two parts: the retinal implant and the glasses. The glasses have a projector that shines light directly onto the implant, which is placed such that cells in the retina are stimulated. This produces an image in the brain!

4. The Rulebook

The Tea: In a reversal of opinion, Senator Cassidy announced his support for Dr. Erica Schwartz as CDC Director.

In last week’s confirmation hearing, Cassidy seemed to feel very critical of Schwartz in his line of questioning. In her responses, Schwartz refused to make it clear whether she would support HHS Secretary Kennedy or if she’d push back on his policy changes. At the time, Cassidy signaled that he may not vote to confirm her. This week Cassidy reversed this position and announced that he is now in support of her. The confirmation hearing was delayed but is set to happen this week.

A few more sips: For a short bio on Dr. Schwartz, read The Rulebook of this issue.

5. The Human Side

The Tea: In this Nature Career Column, Ananya Thakur, a biochemist at the University of Oulu in Finland, goes over her tips for using AI to create a publication graphical abstract. Along with her tricks she discusses the important responsibility authors have in guiding the design and verifying the output.

As someone who includes manually designed graphical abstract-style figures in my newsletters but also encourages time saving with AI, I have conflicting feelings about this. But as I sit with it today, I realize that because I genuinely love the process of creating figures (I find it to be one of most niche strengths!), the problem I have is that AI removes that creation process for me. But not everyone thinks visually and/or enjoys making figures, and that’s okay. But what do you think?

A few more sips: In case you are interest (because you know I was), she references one of her own papers recently published where she followed her own set of rules. My thoughts? It’s not my favorite but also I’ve seen human-designed graphical abstracts be worse. So maybe it’s a win!

Biotech Term of the Week

Paid Subscriber Bonus Content

• A new(er) approach to treating Alzheimer’s gets promising early results ➡️

• Macrocyclic peptides filling the gap between small molecules and antibodies ➡️

• Restoring both function and sensation in a complete spinal chord injury ➡️

• Dexcom is the first participant in the FDA’s TEMPO pilot program ➡️

• A Rhode Island “most wanted” secretly living as a biotech executive ➡️

• Bonus (paid): Global Drug Applications (a table of top countries nomenclature) ➡️

1. Story I’m Watching

The Tea: Biogen and Ionis just broke results from an early study evaluating another arm of their Alzheimer’s pipeline — diranersen. While their FDA approved Alzheimer’s drug, Leqembi, as well as Eli Lilly’s Kisunla, aim to reduce amyloid-beta, diranersen is an antisense oligonucleotide designed to reduce Tau. Up to this point, tau-clearing attempts have been largely unsuccessful, making this an exciting moment.

They announced the results of their Phase 2 CELIA study at this year’s Alzheimer’s Association International Conference (AAIC), demonstrating that diranersen slowed clinical decline by 26% (using one of the secondary endpoints) when administered at one of the doses tested (60mg every 6 months). For reference, the two approved amyloid-beta therapies slow clinical decline in a similar range (27% and 35%) - making it pretty comparable if it holds up in Phase 3 investigations. One potential upside is that diranersen is not expected to lead to the type of brain swelling or micro-bleeding sometimes associated with amyloid-clearing antibodies (known as ARIA). ARIA, while typically asymptomatic, has been one of the larger criticisms of the two available therapies.

A few more sips: While Kisunla and Leqembi are antibodies that bind to and remove aggregating amyloid beta protofibrils and/or plaques, diranersen aims to reduce the production of tau by targeting the upstream MAPT mRNA that produces it.

2. From the Bench

The Tea: Just this past week the FDA approved the first oral PCKS9 inhibitor for lowering cholesterol. Similar to the Psoriasis drug landscape (which we discussed last week), the dominating PCKS9 therapies are injectable monoclonal antibodies. The newly approved Lipfendra, developed by Merck, is a more convenient option for hypercholesterolemia patients.

Lipfendra is a novel macrocyclic peptide. This newer modality is attempting to bridge the gap between convenient small-molecules that can’t always effectively bind to many protein surfaces (the ‘undruggable’ problem) and less convenient but often better-binding antibody injectables. They are intermediate in size, making it so you can harness the benefits of both.

Watch this helpful short video by Merck to better understand how they work!

A few more sips: A few weeks ago (Jun 4 issue) we highlighted Eli Lilly’s novel cholesterol-lowering gene editor, VERVE-102, designed to introduce a stop codon in the PCKS9 gene. This is such a cool example of how you can approach treating disease from multiple angles. We have monoclonal antibody injectables, this newly approved oral inhibitor, and (coming down the pipeline) a gene editing therapy.

3. Bio[Tech]

The Tea: Just last week the latest success in restoring function and sensation in limbs from spinal chord injuries was published in Nature Medicine. A research group from Northwell Health developed a ‘double neural bypass’ (DNB) — designed to simultaneously stimulate the brain and spinal chord — and tested it in a 42-year-old man with quadriplegia, Keith Thomas.

In 2023 Thomas had several electrode arrays and stimulation patches placed and participated in testing sessions multiple times a week. The results were life-changing. His arm strength increased by 86% and 62% (right and left, respectively). Years later, and with the addition of an orthotic device, he is able to drink from a cup, something most people take for granted.

The DNB decodes signals to determine movement intentions and uses tactile sensory pads on the fingers to attempt to provide sensation.

4. The Rulebook

The Tea: The FDA announced the first selected participant in their Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot. Dexcom, Inc., through their Dexcom Glucose Health Program, will be working to implement an AI-powered digital infrastructure that takes data from their glucose sensing devices (Dexcom G7 and Stelo) and contextualizes it with other lifestyle information to provide more personalized and holistic insights to patients.

The pilot is meant to help provide real-world data for how utilizing these kinds of digital tools can make meaningful shifts in managing chronic conditions in the U.S.

A few more sips: Reminder that last month we discussed their over-the-counter Stelo glucose biosensor, which just got approval to be used in children 2 and older. Their G7 device is also a glucose biosensor but is prescription and designed for diabetes management.

5. The Human Side

The Tea: In a departure from previous weeks, this isn’t an inspiring story or a respected opinion, but one of the most upsetting biotech stories I’ve heard in a minute.

A Rhode Island wanted fugitive, Ronald Fischer — convicted (in absentia) of first-degree sexual assault in 2005 — was arrested last week. He has been a fugitive for 20 years and appears to have been working in the biotech industry under an alias, Richard Graydon, for nearly 5! At the time of the arrest he was Chief Medical Officer at Los Angeles-based Immix Biopharma. In a statement from Immix they disclosed that they have terminated him and that in the interview process he claimed to have a robust resume and worked for Merck and J&J. STAT, who broke this story, has said they haven’t been able to yet verify his resume.

I sincerely hope no colleagues had bad experiences with him while he was avoiding prison. While no-one but Fischer is responsible for this, it does make you wonder how we can better vet job candidates.

Biotech Term of the Week

Paid Subscriber Bonus Content

Global Drug Applications

Subscribe now

Read more

• Taking an important step toward better preparedness for Bundibugyo ➡️

• The oral psoriasis competition continues to heighten - a new antagonist ➡️

• How do we detect the parasite, Cyclospora, that has the U.S. in a panic? ➡️

• Overwhelming public opposition to the proposed OMB grant funding changes ➡️

• Exploring Cyclospora misinformation & why poor surveillance made it worse ➡️

• Bonus (paid): Laboratory-Developed Test ➡️

1. Story I’m Watching

The Tea: While the headlines have slowed, the Ebola outbreak in DR Congo has unfortunately continued. I was really thrilled to see that The University of Oxford has begun clinical trials of the ChAdOx1 BDBV (Bundibugyo ebolavirus) vaccine. Despite this not being the first Bundibugyo outbreak (initial outbreak was 2007), we’ve (globally) failed to invest the time and money to get a working vaccine across the finish line. So even just initiating clinical trials is a moment to celebrate.

Recruitment for the trial has begun, which will assess safety and how effectively the vaccine triggers an immune response. They are aiming for 50 healthy adults.

A few more sips: ChAdOx1 BDBV, developed by Oxford’s Vaccine Group and Pandemic Sciences Institute, carries DNA expressing the BDBV glycoprotein inside a weakened adenovirus shell.

2. From the Bench

The Tea: A few weeks back we covered a new oral psoriasis med, as an alternative to the landscape of injectables, with promising data. We discussed how the IL-23 landscape is moving toward this more convenient route of administration.

This week we’re looking at another new oral drug for psoriasis. It is being developed by Avere Therapeutics, which just went public earlier this week! AVR-001 is an interleukin-23 (IL-23) receptor antagonist, blocking the binding of IL-23 to it’s cytokine receptor. I took the previous figure and updated it to include AVR-001 and denote which of the meds of each mechanism of action are oral versus injection.

As you can see, AVR-001 has a competitor — Icotyde (made by J&J) — which was approved earlier this year. What’s different? Mostly the dosing schedule. While Icotyde is a once-daily medication, AVR-001 is being developed as a once-weekly. Finally, you can see that the injectable space is saturated with options. The newer drugs are investigating other mechanisms of action that can be as safe & effective while allowing for formulation in a pill.

Message me if you have a recent science development you’d like to see featured!

3. Bio[Tech]

The Tea: If you hadn’t heard of the parasite known as Cyclospora before this month, you most likely have now. As the United States experiences unusually high numbers of cyclosporiasis (as of writing this, the current outbreak has sickened almost 7,000 people in 34 states), I wanted to dive a bit into the diagnostic tests used to detect it.

Molecular-based gastrointestinal (GI) screening tests are very sensitive and have the ability to detect multiple targets at once. Hospitals that receive patient stool samples either send them out to a certified lab for the test to be run, or run them in-house if they’ve adopted the technology. There are a handful of approved PCR tests that detect the presence of select bacteria, viruses, or parasites that could be the culprit when a patient comes in with GI symptoms. In particular, these include Cyclospora:

• BioFire GI Panel Mid (developed by bioMerieux)

• EasyScreen GI Parasite Detection Kit (developed by Genetic Signatures)

• QIAstat-Dx (developed by Qiagen)

• Gastrointestinal Pathogen Panel (Mayo Clinic LDT)

A few more sips: Some labs or hospitals may not be set-up for PCR testing and opt for more standard microscopy techniques. The problem is that the amount of shed parasite in the sample is often really low resulting in poor detection. It’s recommended consecutive stool samples from multiple days are tested to confirm a negative result. Hospitals should seek out molecular-based testing!

4. The Rulebook

The Tea: A few weeks ago we covered the OMB proposed changes to grant funding (2 CFR part 200) with public comments closing just this week.

The count of responses alone (nearly half a million!!!) demonstrate how serious people feel about the implications of the changes.

An early analysis out of NC Chapel Hill (using AI classification that, of course, will only give us a preliminary view of outlook) showed that about 95% of comments were in opposition of the changes - an overwhelming majority. While it only captured the first ~50k responses, if the subset is a representation of the whole, a revisit of the proposed changes is warranted.

5. The Human Side

The Tea: In this opinion piece, talks us through both why the U.S. has been unable to identify the source of the current Cyclospora outbreak & the dangers of the misinformation that has been circling.

And while Cyclospora, is difficult to trace at baseline, the underlying cuts to surveillance and staffing last year, have undoubtedly made this worse. In the wake of a prolonged period of no identified source, Dr. Kat discusses the danger of the “invented certainty” that circled the internet while the public searched for ways to reduce risk.

“False reassurance is not a neutral outcome. It is a risk that looks like safety.” - Dr. Kat

Biotech Term of the Week

Paid Subscriber Bonus Content

Laboratory-Developed Test

Subscribe now

Read more

👋🏻 It’s been a minute, so I wanted to remind you who is behind the writing! My name is Annicka, I am an industry biotech scientist (experience in analytical development and CMC regulation), I got my PhD in Bioengineering studying AAV gene therapies, and I have also been an online science communicator since 2020.

That combination is why I try to go a layer deeper than most biotech news — not just what happened, but what it means mechanistically and regulatorily. I love making fit-for-purpose figures that help bring it all together, hence the tagline: Part newsletter, part textbook. All biotech.

Thank you so much for being here.

Let’s get into this week’s cup of biotech tea. ☕ If you only have time for one this week, I’d start with #3!

• 2026 may be a record-breaking M&A year for the biotech space ➡️

• A new recombinant protein therapy for autoimmune kidney disease, IgAN ➡️

• Another GLP-1 landscape expansion toward a slow-release implantable device ➡️

• Advancing domestic manufacturing through the FDA PreCheck Pilot Program ➡️

• A physicians take on if you really need 8 hours of sleep ➡️

• Bonus (paid): Market Exclusivity (6th of FDA Encouraging Innovation series) ➡️

1. Story I’m Watching

The Tea: The biotech space is buzzing with merges & acquisitions (M&As) this year, with over 45 deals at a value of around $135B*! In all of 2025, which was actually one of the better years recently, total deal value was $133B. If the second half of this year is as busy, 2026 may be a record year for deals. And what’s more, there is quite a bit of diversity amongst both what is being purchased, and by whom. Let’s break down the M&A 2026 surge into 3 takeaways:

1. The buyer pool has broadened to include more mid-size companies. This is likely on the tail of biotech valuation starting to rebound (but still being much less than the 2020-2021 peak), giving companies that have been outpriced the last few years, an window of opportunity to acquire with their cash reserves.

2. There is diversity in purchased assets. So far this year, oncology is around 33% of total deal value, with immunology-based therapeutics coming in around 29% and neurology-focused drugs around 14%. The remainder cover women’s health, rare disease, and infectious disease.

3. Finally, it is becoming more common to see deals structured to include Contingent Value Rights (CVRs) into deal structures. Essentially, when buyer and seller don’t necessarily agree on the risk profile of a certain early-stage asset, you can put in the deal that money will be tied to certain program milestones. For example, Apellis shareholders will receive $41 per share upfront (from Biogen), plus up to an additional $4 per share based on annual sale goals of their macular degeneration therapy, Syfovre.

A few more sips: Endpoints News covered the first half of 2026 (45 deals at $125B) but since reporting, Vertex acquired Crinetics Pharma for $10B! So, we’re already over the 2025 deal total!

2. From the Bench

The Tea: There is a new therapy on the market for IgA nephropathy (IgAN), an kidney autoimmune disease caused by the buildup of abnormal antibodies in the kidneys. Vera Therapeutics was awarded approval of Trutakna, a recombinant protein therapy that works by reducing the production of these abnormal IgA antibodies, slowing disease progression.

IgAN therapies on the market today, have left room for improvement, with many patients still seeing loss of kidney function over time. Most similar to Trutakna is Otsuka, which was approved by the FDA just last year. While Otsuka targets one important protein in the pathway that leads to abnormal antibody buildup (APRIL), Trutakna targets two (APRIL & BAFF).

The data from the Phase 3 study showed that there was a significant reduction in the protein-to-creatinine ratio which is a strong indicator of kidney function. The group taking Trutakna showed a 45.7% reduction from baseline while the placebo group showed only a 6.8% reduction.

Message me if you have a recent science development you’d like to see featured!

3. Bio[Tech]

The Tea: The GLP-1 space is rapidly evolving as companies compete to find safer, more effective, or more convenient options for patients. Toward the goal of improving convenience… Novo Nordisk, which produces the oral semaglutide Wegovy, just announced a partnership with medtech company, Vivani Medical, to evaluate, and potentially help advance, Vivani’s slow-release implantable GLP-1 system.

Vivani has a proprietary NanoPortal platform technology designed to remain stable in the body and release medication over an extended period of time. The platform can be custom designed per molecule and has demonstrated efficacy using larger molecules and peptides. The therapy is loaded within the device reservoir and slowly released through custom-size nanotubes on the ends of the device.

Vivani has been working on a semaglutide device, NPM-139, and they plan to initiate a Phase 1 trial comparing it to Wegovy injections this year.

A few more sips: On their website, Vivani discusses ‘The Goldilocks Effect’ of nanotube pore size. The ratio of molecule size to pore size is critical for determining release kinetics.

4. The Rulebook

The Tea: The FDA announced the first seven companies participating in their PreCheck Pilot Program, aimed to aid in the readiness of new domestic manufacturing facilities for therapies of unmet needs.

Participants get to engage with the FDA both for building out the manufacturing facility & for the drug application. Pre-submission FDA meetings will provide technical guidance for getting the facility operational and try to identify issues before they potentially delay a submission.

The following companies are the pilot participants:

Amneal Pharma, Cellares Corp., Eli Lilly, FUJIFILM Biotech, Kriya Therapeutics, Kyowa Kirin, and Regeneron.

5. The Human Side

The Tea: In this New York Times opinion piece, Dr. McCormick, a primary care physician, takes us through why the long-held recommendation of 8 hours of sleep is too simplified.

“Both sleep and insomnolency, when immoderate, are bad.” - Hippocrates

While sleep is, of course, biologically very critical, we know that individual needs will vary greatly. Like with all guidelines, they are meant to provide useful guidance that covers the majority, but never fully cover all the nuance. I enjoyed that this piece summarized the general holes to look out for in epidemiology studies, historical sleep patterns we can learn from, as well as what we can observed from other cultures that live differently.

Biotech Term of the Week

Paid Subscriber Bonus Content

Market Exclusivity

Subscribe now

Read more

• Influenza treatment generic approved by the FDA in time for fall Flu season! ➡️

• Building muscle in muscular dystrophy with epigenetic-based therapy ➡️

• A new lung ex-vivo perfusion system may lead to more accepted organs ➡️

• 8 new members of the advisory committee set to meet on peptides in July ➡️

• The similarities between early-career scientists & professional football players ➡️

• Bonus (paid): Orphan Drug Designation (5th of FDA Encouraging Innovation series) ➡️

1. Story I’m Watching

The Tea: The FDA has approved the first generic for the single-dose influenza treatment, XoFluza (baloxavir marboxil).

Most people are familiar with Tamiflu for influenza treatment — but unlike Tamiflu, XoFluza (made by Genentech) is a single-dose treatment and generally better tolerated. But up until now, it’s been quite a bit more expensive (and often not covered by insurance), and therefore harder to find and lesser known.

Norwich Pharmaceuticals obtained FDA approval for it’s generic version, which will provide a lower cost alternative for the upcoming flu season!

A few more sips: Tamiflu (oseltamivir) and XoFluza (baloxavir) work by blocking specific steps in the influenza virus lifecycle. Oseltamivir works by stopping newly made viruses from releasing from the cell. It inhibits the neuraminidase protein on the virus surface which acts as the final rope cutter. Baloxavir inhibits a key protein in the viral RNA polymerase (a cap-dependent endonuclease) that is necessary for viral replication.

2. From the Bench

The Tea: A gene silencing drug successfully harnessed epigenetics to help muscular dystrophy patients gain muscle mass.

Epicrispr Biotechnologies, based in the Bay Area, announced that in a Phase 1/2 trial EPI-321 lead to an average increase in lean muscle of about 0.8 pounds in 3 patients that have facioscapulohumeral muscular dystrophy (FSHD).

EPI-321 is an AAV-based gene therapy carrying the genetic code for what they call their Gene Expression Modulation System (GEMS) — a DNA-binding protein, a guide RNA, and a modulator protein. In the case of this therapy the system recognizes the Dux4 gene, which is turned off in normal cells but remains on in patients with FSHD. Their delivered modulator is designed to add methyl groups to Dux4, acting as an off-switch for expression.

Note that the system isn’t changing the sequence of DNA at all, but rather changing the chemical groups attached to the genome - this is epigenetics!

Message me if you have a recent science development you’d like to see featured!

3. Bio[Tech]

The Tea: A new workflow for pre-transplant lung evaluation has become possible following the recent premarket approval of the LungFX device, developed by Lung Bioengineering.

The LungFX is an ex-vivo lung perfusion system (EVLPs), allowing donated lungs to be perfused in a controlled environment so they can be be properly assessed prior to being accepted by a transplant center for a recipient. But what’s different about this? EVLPs aren’t new. But the infrastructure required to house the device and run it properly, has been limiting. The current EVLP workflow requires a transplant center commit to an organ prior to evaluation.

A drawback to this system is that if the transplant center does not accept the lung, there may not be enough time to transport somewhere else.

The LungFX system is set up to run in two centralized hub facilities (Maryland and Florida) where the lungs are evaluated, and then offered up to transplant centers prior to transporting.

This provides more transplant centers the opportunity to accept before time runs out. It also reduces the burden of multiple facilities housing the infrastructure for EVLP. Finally, if EVLP is concentrated in just a few facilities, you could make an argument for the quality of work being better.

4. The Rulebook

The Tea: The FDA just added the names of 8 new members of the Pharmacy Compounding Advisory Committee (PCAC) that will meet in July to discuss loosening peptide restrictions.

The PCAC is responsible for evaluating the 503A Bulk Drug Substance List which determines which ingredients compounding pharmacies can legally use. The July meeting is set to cover BPC-157, KPV, TB-500, MOTS-C, Emideltide (DSIP), Semax, and Epitalon.

When the announcement of the new members was made, it was met with a lot of concern for bias and lack of expertise (very reminiscent of the concern with the changes to the Advisory Committee for Immunization Practices or ACIP). Several of the members are known to sell or promote peptides.

Back in April we covered RFK Jr. openly hinting at his preference to make peptides more accessible, as well as the FDA announcement to reevaluate several Category 2 substances.

A few more sips: A reminder that none of the 7 peptides have FDA approval that provides a solid indication for use or proof of safety or efficacy. But below is a table summarizing what they are promoted for in the wellness space.

5. The Human Side

The Tea: As the FIFA World Cup is in full swing, this piece is a fun read. In this opinion piece in Nature Career Columns, Sarah Blackford, an academic career consultant, reflects on the similarities between early-career scientists and professional athletes.

“At the early-career stage, both professional footballers and academic researchers are driven by the kind of passion and talent that can demand sacrifices in home life, leisure and personal time. For players, this means long hours at the training ground dreaming of a winning goal in the national league or on the international stage. For researchers, it means hopes for a breakthrough discovery or highly cited paper.” - Sarah Blackford

Biotech Term of the Week

Paid Subscriber Bonus Content

Orphan Drug Designation (ODD)

Subscribe now

Read more

• mRNA-based flu vaccine recommended by FDA advisory committee ➡️

• A CAR-T therapy milestone hit with first solid-tumor approval ➡️

• Dexcom’s OTC continuous-glucose monitor expands to children ➡️

• Denali Therapeutics makes gains by selling their Priority Review Voucher ➡️

• How do you feel about genetic screening in infants? An opinion piece. ➡️

• Bonus: Commissioner’s National PRV (4th of FDA Encouraging Innovation series) ➡️

1. Story I’m Watching

The Tea: The mRNA vaccine platform is expanding with the FDA’s vaccine advisory committee unanimously recommending Moderna’s mFlusiva (mRNA-1010) for adults over 50 this past week. The FDA has now committed to make a decision by August 5th.

mFlusiva is an mRNA-based vaccine similar to that of the Moderna and Pfizer COVID-19 vaccines. A lipid nanoparticle encapsulates three mRNAs that each encode for the hemagglutinin (HA) glycoproteins of influenza A-H1N1, A-H3N2, and B-Victoria. The Phase 3 trial data was published in NEJM last month and showed that the the mRNA-based vaccine reduced the risk of influenza-like illness by 26.6% relative to the standard-dose vaccine it was compared to! This bump in efficacy combined with the added technology benefit of quicker seasonal pivots, may be a game changer for protecting against seasonal strains.

A few more sips: In February it was announced that the agency would not even review the application because they felt that the clinical data did not have a sufficient control arm — they wanted Moderna to compare the new mRNA-based flu vaccine against a currently approved high-dose flu vaccine, instead of a standard-dose. The high-dose flu vaccine is currently what’s recommended for adults over 65. Moderna had revealed that the agency, while hoping for the high-dose comparator, also noted that they would accept the standard dose in the Phase 3 study. The reversal in February left the industry confused. The recommendation by the VRBPAC indicates this concern no longer exists.

2. From the Bench

The Tea: A new CAR-T therapy milestone has been achieved with the first solid-tumor CAR-T therapy approved in China! There are around a dozen approved CAR-T therapies globally but they are for cancers like leukemia, lymphoma, and multiple myeloma, not solid-tumors, which account for a large portion of cancers.

CARsgen, a biotech company headquartered in China, has been developing satri-cel, which is a CAR-T therapy that uses a patient’s own T-cells, after being engineered to recognize a protein known as Claudin 18.2 (CLDN18.2), to treat specific CLDN18.2+ gastric and stomach cancers. Satri-cel’s Phase 2 data, which consisted of patients that had all failed at least 2 prior treatment plans, demonstrated a subtle but meaningful increase in survival (~8 months vs 5.5 months).

I enjoyed this summary on Instagram by Dr. Yasmin Mohseni who works in CAR-T research.

A few more sips: A particular challenge of solid-tumor CAR-T therapy is identifying a target antigen that is not also on healthy tissue. The discovery of CLDN18.2 is an incredibly important advancement for this reason. It is minimally expressed in normal tissue but upregulated in gastric and gastroesophageal junction adenocarcinomas (GEAs).

Message me if you have a recent science development you’d like to see featured!

3. Bio[Tech]

The Tea: We have another FDA approval to discuss (the theme of this week, it seems)! Stelo, made by Dexom, is now the first over-the-counter continuous glucose monitor for children.

Stelo was approved for use in adults in 2024 and is a way to better inform people about how daily lifestyle and diet choices impact their glucose levels. It’s a small, waterproof, device placed on the back of the arm that can be worn for up to 15 days at a time. A small flexible wire is inserted by the applicator into the arm’s subcutaneous tissue, and near real-time glucose values (up to 15 min old) are displayed on the paired phone application. Interstitial blood glucose levels are measured by the wire biosensor, and readings are transmitted via a Bluetooth transmitter.

With this new pediatric clearance, the hope is for the device to be a useful tool in managing prediabetes in children over 2 years old, but who are not using insulin.

4. The Rulebook

The Tea: Denali Therapeutics has sold a previously awarded priority review voucher (PRV) for $195M!

P.S. This bounces nicely off last week’s Biotech term of the Week (where we discussed what a PRV is and how to get one).

Denali Therapeutics is a Bay Area biotech company focused on developing drugs that can cross the blood-brain-barrier (BBB). They were awarded a PRV earlier this year, with the approval of AVLAYAH, an enzyme replacement therapy for pediatric Hunter syndrome treatment. It has not yet been announced who the buyer is. Denali will use it for their clinical pipeline which includes therapies for Sanfilippo syndrome, dementia, Pompe disease, and Alzheimer’s.

A few more sips: Denali has developed a proprietary TransportVehicle (TV) platform that is designed to help large molecules cross the BBB. The TV platform uses engineered Fc domains that bind to native transport receptors (e.g. transferrin, CD98). Target therapies are ferried through the BBB by the specialized transporter.

5. The Human Side

The Tea: The NIH is funding a study to genetically screen 30,000 infants for a panel of different conditions that are able to be treated within the first year of life. This opens up the potential for parents to take early action to prevent or slow-down disease. In this NYT opinion piece, Dr. Daniela Lamas, a physician and mother, walks us through how she thinks about infant genetic screening. She lands on the side of knowledge is power but also understands the hesitancy.

“At the core of our hesitation is a concept called genetic exceptionalism — the idea that genetic information is uniquely dangerous, uniquely frightening, uniquely deserving of protection. For decades this has been a foundational assumption in medical ethics. It has shaped consent laws, insurance protections and the way doctors decide what to tell patients and what to withhold. The question worth asking now is whether that exceptionalism still serves us.” - Dr. Lamas

In her piece she walks us through her experience as a new mother but also earlier infant screening datasets that, to the surprise of some, show that receiving genomic results didn’t increase parental anxiety as much as expected. Dr. Lamas is a proponent of genetic screening but, importantly, building a system that is ready to support it (genetic counseling, parental leave, trained pediatricians, etc.).

Biotech Term of the Week

Paid Subscriber Bonus Content

Commissioner’s National Priority Voucher (CNPV)

Subscribe now

Read more

• Competition in the oral medication for Psoriasis space ➡️

• Using ultrasound to deliver RNA/DNA using microbubbles ➡️

• A more discreet insulin bolus batch for meal-time dosing ➡️

• First approved active sunscreen ingredient in over 25 years ➡️

• Biopharma may be losing out on early AI talent to big tech ➡️

• Bonus (paid): Priority Review Vouchers (3rd of FDA Encouraging Innovation series)➡️

1. Story I’m Watching

The Tea: Psoriasis treatment, which for years has been dominated by frequent antibody injections, is moving toward a future with more oral medication options with the introduction of small-molecule and peptide drugs. Last week, data for a new oral psoriasis candidate, zasocitinib (made by Takeda) demonstrated superiority over the first-in-class drug Sotyktu (made by BMS).

So we’re all on the same page, psoriasis is an immune-mediated chronic disease that results in inflammation and the build up of skin cells causing patchy, red, and itchy skin. Treatment strategies include blocking cytokine signaling (yellow: small-molecule enzyme inhibitors), blocking cytokine binding (green: receptor antagonists), and neutralizing cytokines (blue: monoclonal antibodies).

Zasocitinib is a small-molecule TYK2 inhibitor, stopping the activation of the downstream pathway after cytokine binding. Recent Phase 3 results of the LATITUDE head-to-head study showed that with zasocitinib, “more than 35%” of trial patients showed clearer skin compared to only 14% with Sotyktu (in quotes because data came from a press release). Of note, people taking zasocitinib started to show better improvement as early as 8 weeks, which is meaningful for patients.

2. From the Bench

The Tea: SonoThera just raised $125M for their ultrasound-based gene therapy pipeline. The top two candidates they are pushing toward the clinic are for Duchenne Muscular Dystrophy (DMD) and autosomal dominant polycystic kidney disease.

Most gene therapies you hear about are utilizing a lipid-based nanoparticle or a virus shell to deliver the genetic cargo. In the case of SonoThera, they are utilizing ultrasound to deliver their DNA or RNA alongside microbubbles that carefully disrupt the cell membrane, making it so the nucleic acid can get to the target.

SonoThera isn’t the first to develop ultrasound-based technology for drug delivery. They are among the first to combine the technology with RNA/DNA delivery. Insightec is a medtech company that has developed a precision ultrasound technology that can target highly specific regions of the body paired with MRI. Lotus Neuro is a brand new biotech startup that peeled off of Insightec to develop the technology for delivering to the brain and crossing the blood brain barrier.

A few more sips: Ultrasound delivery has a few potential advantages. One, unlike with viral vectors, the size of the genetic payload is not as limited. For example, when using AAV, there is only 4.2kb space to put your therapeutic gene. Two, redosing is safer with microbubble delivery. Using AAV as an example again, after the first dose, the body will produce anti-AAV antibodies, making future doses less effective (or not possible). Delivery with microbubbles doesn’t produce a lasting immune response.

Message me if you have a recent science development you’d like to see featured!

3. Bio[Tech]

The Tea: Meal-time dosing of insulin is getting easier for patients looking to move away from the standard pen injector. CeQur, a Swiss company, just got two new FDA clearances expanding the use of their CeQur Simplicity insulin patch. On the tails of this success, they also announced raising $100M in seed funding for moving the expansion to commercialization.

What is it? A slim, water-proof, and convenient insulin bolus patch that gives 2U of insulin with the quick squeeze of two side buttons. Up until this week it had only been cleared for use for 4 days at a time, but the latest clearance extends that to 7 days. It also opens the door for a version that gives 1U dosing, which gives better bolus precision for users.

While syringes, pens, and pumps are able to deliver variable amounts of insulin depending on the situation, they are less discreet, less convenient and can require a lot of training. This fills a gap for some Type 1 and Type 2 diabetes patients who are looking for a simple meal-time bolus system.

4. The Rulebook

The Tea: The FDA has approved the first new UV filter in over 25 years — bemotrizinol or BEMT. If you’ve purchased sunscreen while abroad, it’s very likely you’ve already used it. Because it’s such an excellent UV filter, BEMT has been approved in Europe since 2000 and even longer in many Asian countries.

So what was the road block in the U.S.? At a high-level, really strict data requirements. Maximal Usage Trials (MUsTs) are required for topical product NDAs in order to assess how much of the product is systemically absorbed. If the MUsT results find that absorption is over 0.5ng/mL, animal studies that assess reproductive toxicity and carcinogenicity are required. This level of data is not required for approval abroad, because sunscreens are regulated as cosmetics, not drugs.

BEMT, because it is a very bulky molecule, has low systemic absorption (around 0.1ng/mL). Therefore, it already didn’t trigger the animal study requirements. So, the reason it’s taken so long is honestly one of regulatory failure. The last few years we have seen several versions of laws, acts, and guideline updates to try and give the whole landscape a much-needed refresh. It’s very likely that the 2025 provisions in H.R. 5371, which pushed the FDA toward broader data acceptance for sunscreens, finally moved the needle on allowing approval based on the 25+ years of global post-market safety data.

A few more sips: If you’re interested in a recently updated overview of sunscreen, I’d highly recommend this post by .

Your Local Epidemiologist

Here comes the (sun)screen

Summer is close! While sunscreen may seem like an easy health decision, many people, especially younger and health-conscious ones, have questions. Sunscreen health advice and rumors are everywhere, and we’re seeing this reflected in national surveys…

Read more

4 months ago · 558 likes · 56 comments · Dr Michelle Wong and Katelyn Jetelina

5. The Human Side

The Tea: In this opinion piece, we learn a tale of caution for pharma companies losing out on the next generation of AI talent to the more attractive salaries of big tech. Mazdak Abulnaga is a high-performing 33-year-old post-doc developing health and science related AI models. But when he, and others like him, are asked where they are headed, pharma isn’t top priority. Salaries not only tend to be lower but pharma has a ways to go when it comes to embracing AI and showing up in tech spaces as invested players.

Biotech Term of the Week

Paid Subscriber Bonus Content

Priority Review Vouchers (PRVs)

Subscribe now

Read more

🙏🏼 A few of you have already claimed the Early Supporter discount (lifetime access at $20/year), and I’m excited to welcome more readers to Biotech Term of the Week. The offer closes tonight and won’t be offered again. If you've been considering supporting The Biotech Tea ☕, now is a good time.

Get 33% off forever

Let’s get into this week’s cup of biotech tea. ☕ If you only have time for one this week, I’d start with #1!

• A peak into CEO-to-Worker salary ratios and insights➡️

• We hear about the measles vaccine but what about a new antibody treatment?➡️

• An tissue engineered heart muscle patch used for heart failure patients➡️

• Do blood pressure wearables get regulated as medial devices?➡️

• A physician-scientists take on the ‘reference paradox’ for job applications➡️

• Bonus (paid): Humanitarian Device Exemption (2nd of FDA Encouraging Innovation series) ➡️

1. Story I’m Watching

The Tea: Endpoint News has begun releasing parts of their biopharma employee salary report for 2025 and they reported the median biopharma salary (which they weighted for head-count of company) was $115.6k. That’s higher than the typical salary for an employee of an S&P500 company.

What struck me most was looking at the CEO-to-Worker salary ratios. ThermoFisher has the highest (1120) with the CEO making $79.9M. Novo Nordisk has the lowest (19.9) with the CEO making $3.5M.

I spent some time looking at the numbers, graphing them in ways that helped bring some stories to light, and coming up with groups I felt were insightful.

• Worker-Pay Leaders I defined as companies with a CEO-to-Worker ratio <100 and a median worker pay >$200k. You can see no CEOs make more than $25M in this category. Incyte just barely misses the grouping because while the median worker salary was quite high, the CEO made $32.1M.

• High Disparity Zone I defined as a CEO-to-Worker ratio >200. While the majority of companies in this group have higher bucketed CEO salaries, Revvity is unique for this category in that the CEO makes less than $15M. But because the typical median worker salary is so low, it makes it into this category.

Take a look at the graph and let me know what insights you find!

A few more sips: Portland, OR was the first place to pass a business tax surcharge based on CEO-to-Worker salary ratios. In San Francisco the ‘Overpaid CEO tax’ narrowly failed passing just last week. And in 2025, the Tax Excessive CEO Pay Act was reintroduced, aiming for the same kind of penalty system for high disparities between CEOs and workers.

2. From the Bench

The Tea: With the unfortunate resurgence of Measles, better understanding how vaccine-derived antibodies neutralize the virus (where exactly they bind) is important information for developing antibody therapies.

Real quick: It may surprise you when you realize that we don’t already have a Measles-specific treatment, but it’s because preventing infection of the highly contagious virus, through vaccination, is so effective. And with the disease being eradicated in the U.S. in 2000, efforts for a treatment weren’t prioritized and new technology hasn’t been applied. Back to the findings…

Researchers at La Jolla Institute for Immunology recently published their work characterizing antibodies from people who had been immunized and data showing what specific regions the antibodies recognize on two important viral surface proteins — hemagglutinin (H) and fusion (F). This kind of virus-to-antibody mapping work isn’t novel, but it fills important gaps in our understanding of Measles virus immunity. It opens the door to developing an antibody therapy that could be used for pre- or post-exposure therapy in high-risk groups if Measles cases continue to rise.

A few more sips: There is also work being done to develop antivirals against Measles! A lab at Georgia State University, in particular, recently published data on a broad spectrum drug targeting machinery of orthoparamyxoviruses (e.g. measles & parainfluenza). The work was funded by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institutes of Health (NIH). It has yet to be tested in humans but showed promise in animal studies.

A few more sips:

Message me if you have a recent science development you’d like to see featured!

3. Bio[Tech]

The Tea: Researchers in Germany have engineered a patch of heart muscle derived from stem-cells that shows potential in boosting weakened heart tissue in heart failure patients.

At late stages of heart failure, the heart loses its ability to effectively pump blood, and you see a significantly lowered left ventricular ejection fraction (LVEF). It is in those scenarios that a patient may be indicated for a left ventricular assist device (LVAD), which is literally a pump that is inserted into the ventricle of the heart that assists the heart in circulating blood throughout the body. (Fun fact: Yours truly worked as an LVAD tech part time during undergrad and it was a really fun job that exposed me to clinical care and retrospective research).

A total of 16 patients (who had heart failure and a LVEF less than 35%) received the engineered heart muscle patch and were followed up for 3 months. The heart wall showed an increase in thickness and the LVEF demonstrated a small improvement.

4. The Rulebook

The Tea: Earlier this year the updated FDA guidance that relaxed regulation on wearables (low-risk devices) “intended for only general wellness”, which has opened the floodgates for companies to offer blood pressure readings.

“FDA may consider certain products that use non-invasive sensing (e.g. optical sensing) to estimate, infer, or output physiologic parameters (e.g. blood pressure, oxygen saturation, blood glucose, heart rate variability) to be general wellness products when such outputs are intended solely for wellness uses…” - Guidance Doc

In just the last few months the list of wearables with this feature has skyrocketed — Whoop, Oura, Samsung, Pin Pulse, just to name a few (Apple sought FDA clearance for it’s feature). While some consumers may appreciate this added feature, many are skeptical that allowing devices to give this kind of information without regulation could result in patients not seeking accurate diagnostic measurements and proper care.

A few more sips: How does a wearable blood pressure measurement even work? Most of the devices repurpose the sensor used to measure heart rate but apply specific algorithms that try to use the readings to infer pulse volume and pressures. At the end of last year the American Heart Association published a statement warning against the lack of accuracy and precision in the cuff-less blood pressure tech.

5. The Human Side

The Tea: In this opinion piece by physician-scientist Bibek Aryal, he argues against the usefulness (and hinderance) of letters of recommendations for first round job applications.

His reasoning is two-fold: in a highly digital era, we no longer rely on letters from former employers to confirm skills, publications, or degrees. Second, it is a privilege (and something quite out of our control) to have mentors that will take the time (often again and again) to write recommendations.

Aryal isn’t anti-recommendation entirely, but suggests that they be only used for finalists.

Biotech Term of the Week

Paid Subscriber Bonus Content

Humanitarian Device Exemption (HDE) (FDA Encouraging Innovation series)

Subscribe now

Read more

🎉 Lucky Issue 13!!!

I’m thrilled to see this community grow faster than I imagined. To celebrate, I’m opening 10 early supporter spots at 33% off for life ($20/year) ☕

Get 33% off forever

Paid subscribers get the Biotech Term of the Week, where we break down biotech concepts, technologies, or terms you’ll encounter again & again in the industry. We’re starting a new series, and I’d love more readers to join us.

Let’s get into this week’s cup of biotech tea. ☕ If you only have time for one this week, I’d start with #1!

• Researchers get a standing ovation for pancreatic cancer data ➡️

• A gene editor for cholesterol reduction may change heart disease treatment➡️

• Sleep apnea detection using Apple watch sensors➡️

• Proposed change to grant review tighten criteria & shift priorities➡️

• The story of an American ER physician surviving Ebola➡️

• Bonus (paid): Grant Programs (1st of FDA Encouraging Innovation series)➡️

1. Story I’m Watching

The Tea: It’s likely you’ve heard (or seen videos) about the standing ovation earned by Phase III clinical trial results for pancreatic cancer drug, daraxonrasib, presented at the American Society of Clinical Oncology (ASCO) annual conference.

The trial showed that daraxonrasib, a small-molecule inhibitor made by California-based biotech Revolution Medicines, doubled the survival of patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) compared to gold standard chemotherapy. While the median overall survival on chemo was only 6.6 months, those on the trial drug saw a median survival of 13.2 months.

A few more sips: Not being in this specific field myself, I immediately wanted to better grasp how this fits into the larger pancreatic cancer therapy picture. This gives context to the standing ovation.

It turns out that more than 90% of PDACs have a mutation in KRAS (part of the RAS family) that favors the ON state, driving lots of important cell pathways, including cell proliferation.

Small-molecule inhibitors that halt cell pathways, are not new, but it also turns out that KRAS has a particularly “smooth” binding domain and years of work in this space has yielded relatively few successes in blocking the pathway. Research in 2013 identified a “druggable” pocket which eventually led to the approval of two KRAS G12C (the particular mutation) inhibitors that try to lock KRAS in the OFF state — sotorasib and adagrasib. These two drugs, were celebrated upon their approval as well!

We also have a whole emerging modality called protein degraders that have been applied to the RAS pathway. The idea is to tag these proteins for the cell’s disposal machinery so they don’t even exist to propagate the cell proliferation pathways. In March, successful human data was reported on a degrader called setidegrasib, showing it could reduce tumors in lung and pancreatic cancer.

Finally, we get to daraxonrasib (which got the claps). Scientists at Revolution Medicines took the approach of blocking the binding site of RAS while in the ON state, preventing it from binding to proteins that are next steps in critical pathways (downstream signaling inhibition).

I hope this mini crash-course on KRAS and pancreatic cancer helps you understand the importance of the latest findings.

2. From the Bench

The Tea: While many gene therapies are targeting rare genetic diseases, Eli Lilly just released positive Phase 1 data for their gene editing drug, VERVE-102, in the heart disease space.

Besides not often hearing gene therapy and cardiovascular disease in the same sentence, what, in particular, is new about this? Well, we already know that inhibiting the PCSK9 gene in the liver results in reduced low-density lipoprotein (LDL) cholesterol, lowering risk of cardiovascular disease — currently, doctors can prescribe PCSK9 inhibitors in the form of an oral medication that needs to be consistently taken in order to see it’s long-term benefits to health.

VERVE-102 shifts the burden off the patient with a single IV dose that directly modifies the DNA in liver cells to perpetually turn-off (or lower expression of) the PCKS9 gene. The Phase 1b trial was tested in 35 individuals with hypercholesterolemia or premature coronary artery disease and in all but the lowest doses, there was a significant and lasting reduction in LDL.

A few more sips: I am not only looking forward to the future trial data on VERVE-102, but also VERVE-201, which uses the same platform technology but targets ANGPTL3 with the hopes of reducing both LDL cholesterol and triglyceride. That data isn’t expected until late next year or early 2028.

And while we’re talking about the line-up, I found it interesting that the earlier version of this drug (VERVE-101) showed liver toxicity and Lilly has said that their redesign of the lipid nanoparticle (LNP) carrier now minimizes that concern. The LNP now includes a particular sugar (GalNAc) that improves liver cell entry in a way that improves patient safety. VERVE-102 was already in their pipeline at the time of halting VERVE-101. An example of how an iterative pipeline can be beneficial.

Quick call back to issue No. 5 where we discussed another gene editor using LNPs (it was a split system with AAV carrying part too!) for the treatment of urea cycle disorders.

Message me if you have a recent science development you’d like to see featured!

3. Bio[Tech]

The Tea: Apple recently released a sleep apnea feature on the Apple watch, which evaluates disruptions in breathing during sleep.

Sleep apnea, which affects an estimated 30 million people in the U.S., is defined by what is known as apnea-hypopnea events or the apnea-hypopnea index (AHI). Apple has developed a new algorithm that takes motion readings from the watch’s triaxial accelerometer sensor and identifies what it thinks are breathing disturbances that could be apnea-hypopnea events. The consumer can review breathing disturbance values in application, but they will also be sent a notification if the algorithm detects an elevated disturbance read over a 30-day period, suggesting they may want to be evaluated for sleep apnea. Apple revealed data on their design, implementation, and validation phases, which included thousands of participants, in a white paper.

A few more sips: When it comes to wearables and wellness values, the major question is whether or not the proxy for a true diagnostic test will hinder (or unnecessarily prompt) proper care. To address this, Apple states in it’s technical white paper, that they took a cautious approach. While specificity for the alert was 98.5% (meaning you are very unlikely to get an alert if you do not have sleep apnea), sensitivity only came in at 66.5% (meaning the device will not alert quite a large portion of people who do have sleep apnea).

4. The Rulebook

The Tea: Late last week the U.S. Office of Management and Budget (OMB), which oversees the federal budget, released a proposal to significantly revise the way federal research grants are approved and what they can fund.

Some of the larger proposed changes? Agency senior appointees would be required to review all grants (and have ultimate veto power), the President’s policy priorities would be prioritized, grants could be terminated at any time, and the rules for what grant money can be used for gets much tighter (for example, needing pre-approval for conference attendance & not covering journal fees).

In part, the aim is to reduce spending, but they also state that the changes would keep activities “consistent with law and policy”, hold recipients “accountable when they fail to meet relevant standards”, and “ensure that basic American principles of equality and equal opportunity are upheld”.

A few more sips: I found this article by incredibly helpful for breaking down the long list of proposed changes and what their implications are.

5. The Human Side

The Tea: Craig Spencer is an emergency medicine physician and public health professor at Brown University, but in this NYT piece he’s speaking as an Ebola survivor.

He contracted the virus during the outbreak of Zaire ebolavirus in West Africa between 2014 and 2016, which resulted in over 11,000 deaths and spread through 10 countries. Spencer carefully lays out why the current outbreak is so dangerous — from a geography riddled with violence, a species of ebolavirus with no vaccine or treatment, and a U.S. administration that has retreated from robust global humanitarian aid.

Biotech Term of the Week

Paid Subscriber Bonus Content

Grant Programs (FDA Encouraging Innovation series)

Subscribe now

Read more