👋 Good morning! If you’re looking for the most stable job in U.S. public health right now, it might be updating the org chart.

Jim O’Neill, deputy secretary at HHS and acting CDC director, is out. That leaves the CDC without a confirmed leader… again. President Trump has not named a replacement, permanent or interim. The most senior official on paper is principal deputy director Ralph Abraham, who was sworn in by HHS Secretary Robert F. Kennedy Jr. in December, but even he has deferred leadership questions back to the White House.

This follows the brief 28-day tenure of former CDC Director Susan Monarez, who was fired last year after reportedly refusing to “preapprove” recommendations from the CDC’s vaccine advisory panel. Now O’Neill’s exit adds another chapter to what has become a revolving door at the nation’s top public health agency.

Meanwhile, vaccine policy remains politically radioactive. Leadership churn at the CDC. High-profile FDA clashes over flu shots. And internal shakeups at HHS. If stability builds trust, this is not exactly a trust-building exercise.

Some agencies measure productivity in publications. Others in approvals. Right now, HHS might measure it in resignation letters.

✌️ Sanofi Swaps CEOs, Stock Drops 5%
Sanofi has replaced CEO Paul Hudson after six years marked by R&D stumbles and uneven growth, tapping Merck KGaA chief Belén Garijo to take over April 29. Olivier Charmeil will serve as interim CEO starting Feb. 17. Garijo is expected to bring what Sanofi called “increased rigor” to R&D execution and governance. Translation: fewer pipeline whiffs, more productivity. Investors were not immediately convinced. Shares fell nearly 5% in premarket trading, with some analysts questioning whether Garijo’s track record at Merck KGaA’s pharma unit was strong enough to justify the bet. New leadership. Same pressure. The pipeline clock keeps ticking.

💊 Lilly Stockpiles $1.5B in Oral GLP-1 Inventory
Eli Lilly is not getting caught short again. The company disclosed $1.5 billion in pre-launch inventory as of Dec. 31, most tied to oral GLP-1 candidate orforglipron. For context, that is nearly triple the roughly $550 million it had stockpiled a year earlier. The move is a direct response to early shortages that plagued Mounjaro and Zepbound and helped fuel a compounding gray market. With an FDA decision now expected April 10, Lilly appears determined to launch at scale on day one. When you’re going head-to-head with Novo’s Wegovy pill, you do not want to run out in week two.

⚖️ Biohaven CEO Says FDA Is “Systemic” Problem
After the FDA rejected Biohaven’s spinocerebellar ataxia therapy, CEO Vlad Coric is not staying quiet. He argues the decision reflects a broader shift at the agency that is slowing rare disease innovation, pointing to similar friction around Regenxbio and Stealth BioTherapeutics. He also referenced the FDA’s recent refusal to review Moderna’s flu vaccine. Coric’s warning: if there is no clear regulatory path forward, programs die. And in rare disease, that means patients are left with nothing. The biotech industry has long tolerated tough regulators. What it struggles with is unpredictability.

🤷‍♀️ Moderna’s Breakeven Target? “Fresh and Fluid.”
Moderna reported $678 million in Q4 revenue and $1.9 billion for full-year 2025, landing at the high end of prior guidance. Shares climbed nearly 9% after earnings. But one word was conspicuously absent: breakeven. The company previously targeted 2028 as its profitability milestone. After the FDA refused to review its flu vaccine mRNA-1010, executives now say that path is “fresh and fluid.” CFO Jamey Mock acknowledged the uncertainty, noting it is difficult to project forward without clarity on a potential $1 billion revenue opportunity. Moderna may still grow 10% in 2026, primarily internationally. But flu was supposed to help stabilize the respiratory franchise. That math just got harder.

👊 AbbVie Sues Over Botox IRA Inclusion
AbbVie has joined the growing wave of litigation against the Inflation Reduction Act’s drug pricing provisions, arguing that Botox should be excluded from Medicare negotiations. The company’s angle is specific: Botox contains human serum albumin derived from plasma, and plasma-derived products are explicitly excluded under the statute. CMS has said plasma-derived products will be exempt. AbbVie says Botox qualifies. At stake is not just one aesthetic blockbuster, but how narrowly or broadly CMS interprets the law’s exclusions. When billions are on the table, statutory definitions get very detailed very fast.

🫤 Seres Pauses Lead Program, Cuts Staff 30%. Months after laying off 25% of staff to fund its microbiome therapy SER-155, Seres is halting the trial and trimming another 30% as cash runway stretches only into Q3.

🩸 Disc Medicine Gets CRL. The FDA rejected rare blood drug bitopertin despite priority review, citing reliance on a surrogate endpoint.

📉 Icon Revokes Guidance. The CRO launched an accounting probe after discovering revenue may have been overstated by less than 2%, sending shares down nearly 37%.

🇮🇪 Novo Eyes Ireland Expansion. With Wegovy pills flying in the U.S., Novo plans to boost overseas supply capacity in Athlone to regain GLP-1 momentum.

🦴 Ultragenyx Cuts Staff 10%. After failed brittle bone trials and fresh FDA manufacturing questions, 130 employees are heading out.

😬 CSL Profit Plunges 80%+. Net profit fell from $2 billion to $384 million, weighed down by $715 million in restructuring and $1.1 billion in impairments.

💰 Alnylam Turns Profitable. After 23 years, the RNAi pioneer posted $314 million in GAAP net income, with TTR franchise revenue projected to grow 83% in 2026.

Europe produces world-class science. It just does not keep the upside.

A new European Life Sciences Coalition has launched with backing from Novo Holdings, Sofinnova Partners, Forbion, Omega Funds and others representing €24 billion ($28.6 billion) in life science assets. Their message is blunt: Europe cannot finance its own biotech future.

European VC accounts for just 7% of global venture capital. The U.S. controls 63%. China holds 14%. Of the 67 EU-based biotechs that went public last year, all but one listed outside the EU. That is not a pipeline issue. That is a capital markets issue.

Europe is home to five of the top 10 pharma companies by revenue. The industry supports 29 million EU jobs. Yet scaling companies still flee to U.S. exchanges and American growth capital. Fragmented markets, regulatory hurdles and shrinking pools of specialized VCs have limited growth-stage funding. In January, investment firm Gimv exited life sciences altogether. Meanwhile, Andreessen Horowitz just launched a $700 million biotech fund in the U.S., and China continues executing on a multi-year biotech dominance plan. Capital follows conviction. Right now, Europe is asking for more of both.

Brussels is trying. The European Commission recently floated a Biotech Act to accelerate development timelines. The European Investment Bank committed €150 million alongside Angelini Industries to fund biotech, medtech and digital health companies. Servier launched a €200 million venture fund focused on European oncology and neurology startups.

Those are meaningful moves. But when U.S. venture deploys tens of billions annually, €150 million feels more symbolic than structural.

Biotech is not just an industry. It is strategic infrastructure. If Europe cannot provide deep, patient capital through Phase 3 and commercialization, it will keep exporting innovation. That means exporting jobs, manufacturing, and long-term economic leverage.

The coalition’s pitch is simple: if Europe wants to compete, it has to pay for it. Because in biotech, science wins awards. Capital wins markets.

That is the estimated annual taxpayer cost of FDA biologics chief Vinay Prasad commuting biweekly from San Francisco to Maryland. The number surfaced as scrutiny builds around his decision to overrule staff and issue a refusal-to-file letter to Moderna’s flu vaccine. Add internal complaints and mounting political pressure, and it is safe to say the travel budget is not the only thing under review.

Here’s what biotech Redditors are talking about:

👩‍🔬 What’s the point of my PhD if I can’t get a job?
A Reddit thread captured the biotech job market mood. One hiring manager admitted there are so many PhD applicants that interviews must be prioritized toward candidates with industry experience. Others were more blunt: claiming leadership because you mentored undergrads or overstating technical expertise is not helping. Entry-level scientist means entry-level. The market is tight, but self-awareness still matters.

👏 Being contrarian doesn’t mean being right.
In a separate thread, commenters dissected reports that Vinay Prasad overruled FDA staff on Moderna’s flu vaccine filing. Some praised whistleblowers inside the agency. Others argued Prasad built his brand on contrarian takes in oncology and vaccines. The debate now is less about personality and more about process. Who is steering regulatory decisions, and how predictable are they?

💸 VC Recovery, With Discipline. Biopharma deal value hit $33.8 billion in 2025 as investors favored fewer, larger, de-risked bets.

🏢 Boston Vacancy Hits 28%. Life science real estate availability reached an all-time high as new construction slowed.

❌ Moderna Cuts R&D Spend 31%. Spending fell to $3.1 billion in 2025 as major Phase 3 respiratory trials wound down.

🩺 Surge Therapeutics Injects Immunotherapy at the Moment of Surgery
Surge is betting that removing a tumor and then walking away is a missed opportunity. Its lead candidate SRG-514 is injected directly into the tumor bed during surgery, aiming to wipe out residual cancer cells before recurrence begins. Founder Michael Goldberg built the company around a simple premise: if 9 million patients undergo tumor resection each year and 40% recur within five years, why not deliver therapy at the exact moment of highest vulnerability? Backed by Robert Langer and fresh off dosing the final patient in Phase 1, Surge plans a pivotal Phase 3 in breast cancer this summer. If successful, it could turn the operating room into the first line of immunotherapy.

🌊 February 17, 1969 — SEALAB III Tragedy
American aquanaut Berry L. Cannon died of carbon dioxide poisoning while attempting to repair a leak in the Navy’s SEALAB III underwater habitat. A failed carbon dioxide absorbent canister ended the mission and led to the program’s abandonment.

If you feel like every week brings another resignation, firing, or “leadership transition” at NIH, CDC, or HHS… you are not imagining it.

At this rate, the best investment in biotech might be in the company making name plates for office doors at public health organizations. 😅

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

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