👋 Good morning! Last week, the FDA told Moderna to take its flu vaccine filing and try again. This week? “Come on in.”

After issuing a refusal-to-file letter over concerns that Moderna’s comparator did not reflect the best available U.S. standard of care, the agency has now accepted an amended application for mRNA-1010. The decision came just over a week after the rejection, an unusually fast reversal that has the biotech back on track for a potential approval by Aug. 5, in time for the 2026–27 flu season.

The revised filing splits the path: full approval for adults 50 to 64 and accelerated approval for adults 65 and older, with a post-marketing study commitment. Translation: compromise achieved.

Type A meetings with the FDA typically take 30 days. Moderna speedran the process. If regulatory drama were a rom-com, this would be the airport chase scene.

🏭 Johnson & Johnson Drops $1B on Pennsylvania Cell Therapy Plant
With $55 billion earmarked for U.S. expansion, Johnson & Johnson just added detail to the plan: a $1 billion next-gen cell therapy manufacturing facility in Pennsylvania. The Montgomery County plant will create 500 permanent biomanufacturing jobs and more than 4,000 construction roles while it is built. The move aligns with broader domestic investment efforts as pharma companies navigate tariff threats and geopolitical pressure. J&J is not just hedging policy risk. It is locking in U.S. cell therapy capacity for the long game.

💰 Novartis Bets $1.7B on AI-Designed Macrocycles
Novartis is paying $100 million upfront to partner with Unnatural Products in a cardiovascular deal worth up to $1.7 billion in milestones. The prize is an AI-guided macrocyclic peptide platform designed to generate potent, selective therapies that can be delivered orally or via injection. Novartis will handle development and commercialization, while Unnatural Products collects milestones and royalties. Big Pharma continues its favorite hobby: outsourcing early innovation, insourcing late-stage execution.

🧪 Gilead Hands Over $80M for Synthetic Lethal Cancer Play
Gilead secured global rights to Genhouse Bio’s clinic-ready MAT2A-targeting cancer therapy, paying $80 million upfront with up to $1.45 billion in milestones on the table. The asset, GH31, already has clearance to enter trials in both China and the U.S. It is the second synthetic lethal pickup for Gilead in recent months, signaling a clear oncology strategy: stack precision bets and see which one hits. The synthetic lethal arms race is officially global.

💸 Lilly Pays $100M for IL-6 Antibody Second Chance
Eli Lilly is betting that CSL’s phase 3-stage IL-6 antibody clazakizumab deserves another shot. The $100 million upfront deal gives Lilly rights outside CSL’s ongoing cardiovascular study in dialysis patients, even after a kidney transplant rejection trial was terminated early for lack of efficacy. CSL remains eligible for milestones and royalties. Lilly gets optionality. CSL gets a partner willing to rerun the experiment somewhere else.

🥼 NIH Director Takes Over CDC. Jay Bhattacharya will step in as acting CDC director following Jim O’Neill’s departure, adding another leadership shuffle to federal health agencies.

📈 Roche Eyes Kidney Expansion for Gazyva. Phase 3 data showed superior remission rates over tacrolimus in primary membranous nephropathy, setting up regulatory talks.

💊 Novartis Files Rhapsido in Chronic Hives Subtype. The oral BTK inhibitor hit its phase 3 endpoint in chronic inducible urticaria and could become the first targeted therapy in the condition.

🥇 Lilly’s Zepbound Combo Scores Again. Pairing Zepbound with Taltz delivered added benefit in obese psoriasis patients in a phase 3b trial.

👁️ Ocular Therapeutix Tops Eylea in Phase 3. Axpaxli beat Regeneron’s blockbuster in wet AMD, though shares fell 25% as investors debated how strong the win really was.

🏭 Stada Invests €85M in Saudi Hub. The German drugmaker is building a Middle East manufacturing site to supply essential medicines across the MENA region.

🧬 Boehringer Axes Inhaled Gene Therapy. The company scrapped its cystic fibrosis program after phase 1/2 data failed to support further development.

Ten months after biotech leaders sent letters sounding the alarm, Senate HELP Committee chair Bill Cassidy has released an 18-page vision for reshaping the FDA. The message is not subtle. If the U.S. wants to stay competitive, the agency needs more flexibility, more transparency and fewer bottlenecks.

Cassidy’s proposals touch nearly every pressure point: expanding novel trial designs, modernizing rare disease pathways, rethinking accelerated approval beyond oncology and clarifying biosimilar interchangeability. More than 80% of accelerated approvals between 2010 and 2021 went to cancer drugs. Cassidy argues that needs to change. Rare disease developers, many of them small companies running 70% of late-stage programs, are shouldering high regulatory costs in a system not built for personalized medicine.

At the same time, FDA Commissioner Marty Makary is warning that the U.S. is losing ground to China in early-stage drug development. Hospital contracting, ethics reviews and IND processes are described as “clunky.” China now runs more clinical trials than the U.S. and could account for 35% of FDA approvals by 2040. That is not just competition. That is acceleration.

The political twist? Cassidy voted to advance Robert F. Kennedy Jr. to lead HHS while also voicing vaccine concerns. Now he is calling for accountability and collaboration at an agency that has experienced layoffs, leadership churn and rising industry frustration. Reform is no longer a partisan talking point. It is becoming a competitiveness argument.

Biotech does not fear tough regulators. It fears unpredictable ones. If Congress and FDA leadership align around clearer rules, faster early-stage processes and modernized rare disease pathways, the U.S. keeps its edge. If not, capital and trials will continue to migrate.

In biotech, speed is strategy.

That is how much Bayer is allocating to settle ongoing and future Roundup claims tied to alleged non-Hodgkin lymphoma injuries. The structure includes capped annual payments over up to 21 years, part of an effort to contain litigation that has already cost the company more than $10 billion. Nearly 197,000 cases have been filed. Bayer insists the settlement contains no admission of wrongdoing. But at this scale, legal strategy becomes balance sheet strategy.

Here’s what biotech Redditors are talking about:

🧨 Things like this get destroyed much quicker than they can be rebuilt.
Redditors reacted strongly to reports that a key U.S. infectious disease center is scrubbing pandemic preparedness and biodefense language from its website. Many worry it echoes early 2020 complacency. Others pointed out how difficult it is to rebuild institutional capacity once talent and funding disperse. Stability, in biotech and public health, is compounding. So is instability.

😤 Five hour interview… for a three month contract.
Another thread detailed a five hour interview process for a short-term role, followed by total silence. Some commenters demanded companies be named and shamed. Others warned that in this job market, few can afford to burn bridges. The biotech hiring process may be broken. But so is the leverage equation.

🗾 Innovacell Targets $92M Tokyo IPO. Japan’s biotech IPO drought could end Feb. 24 as the cell therapy company prices shares at 1,350 yen.

👃 Cyrano Smells Phase 3. Its smell loss therapy hit its phase 2 endpoint in 151 patients and is heading to pivotal trials.

🍄 Compass Scores Second Phase 3 Win. Psilocybin therapy for treatment-resistant depression cleared another hurdle, sending shares up 30% and teeing up filing talks.

🧠 Korsana Raises $175M to Sneak Antibodies Past the Blood-Brain Barrier
Korsana Biosciences emerged from stealth with $175 million and a plan to tackle Alzheimer’s by hijacking the brain’s iron transport system. Its lead candidate binds transferrin receptors to cross the blood-brain barrier and clear amyloid plaques, with a clinical debut planned for 2027. Founder Jonathan Violin is aiming for injections instead of the cumbersome IV infusions required by current therapies. In a crowded Alzheimer’s field, delivery may be the real differentiator.

🫀 February 19, 1985 — Artificial Heart Milestone
William J. Schroeder became the first artificial heart recipient to leave the hospital after receiving the Jarvik 7 device. He survived 620 days, the longest at the time. A reminder that medical breakthroughs are rarely smooth, often controversial and always a mix of hope and hard lessons.

If your boss shut down your idea on Monday, do not panic.

Apparently, you just need seven days and a revised slide deck.

The FDA went from “refusal to file” to “see you in August” faster than most of us can schedule a follow-up meeting. So update the slide deck. Rebook the conference room. Pretend you were never annoyed.

That’s all for today. See you Tuesday for the next issue. 👋

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