👋 Good morning! Vinay Prasad’s tenure running the FDA’s biologics shop always felt a little… combustible.

Now it’s officially ending.

After less than a year as director of the FDA’s Center for Biologics Evaluation and Research, Prasad will depart the agency at the end of April. The oncologist-turned-regulator had technically been on a one-year leave from academia, but his short stint overseeing vaccines and gene therapies produced a surprising amount of turbulence.

Rare disease advocates never warmed to his stricter regulatory posture. Gene therapy developers accused the agency of moving the goalposts. And industry frustration spilled into headlines as several high-profile therapies ran into unexpected resistance.

The most dramatic example? A Huntington’s disease gene therapy from uniQure that had investors, regulators and patient groups openly sparring in public. Check out the Deep Dive section halfway down the page for the full uniQure vs. FDA story. It’s a juicy one.

For now, the FDA is searching for a new CBER chief. Whoever takes the job will inherit one of the most politically charged desks in biotech. Vaccines, gene therapies and cell therapies now sit squarely at the intersection of science, money and Washington theater.

And as Prasad’s tenure proved, that intersection can get loud.

🤝 Novo and Hims End the GLP-1 Breakup Saga
Just weeks after threatening legal war, Novo Nordisk and telehealth platform Hims & Hers are suddenly back on speaking terms. Novo dropped its patent lawsuit after the companies struck a deal allowing Hims to sell branded semaglutide products including Ozempic and Wegovy. In return, Hims agreed to stop broadly marketing compounded GLP-1 knockoffs except in rare clinical cases. Hims stock promptly rocketed more than 50% in premarket trading. The whole saga feels like that couple who breaks up loudly… then shows up to brunch together the next week.

💰 Servier Writes $2.5B Check for Day One Biopharma
Servier is doubling down on rare oncology with a $2.5 billion acquisition of Day One Biopharmaceuticals. The prize is Ojemda, an FDA-approved RAF inhibitor for pediatric low-grade glioma that launched last year. Beyond the commercial drug, Servier also gets a pipeline of programs targeting both pediatric and adult tumors. The deal comes with a hefty 68% premium for Day One shareholders. Rare cancer drugs remain one of biotech’s most reliable deal magnets.

🏅 Regeneron’s Obesity Entrant Shows Zepbound-Level Weight Loss
Regeneron’s Chinese partner Hansoh Pharma reported up to 19.3% weight loss in a phase 3 trial for its GLP-1/GIP drug olatorepatide. That puts the therapy within striking distance of Eli Lilly’s Zepbound, which reached about 21% in its own studies. Regeneron licensed the drug last year for $80 million upfront as part of its late entry into the obesity race. Matching Lilly on efficacy is one thing. Convincing doctors and insurers to switch is another.

👍 J&J’s Myeloma Combo Earns Ultra-Fast FDA Nod
Johnson & Johnson secured the third approval under the FDA’s National Priority Voucher pilot program for its Tecvayli and Darzalex combination in multiple myeloma. The phase 3 trial showed an 83% reduction in the risk of progression or death compared to standard regimens. When regulators see blockbuster-level data, the fast lane apparently gets even faster.

💉 Pfizer Breaks Into China’s Obesity Market
Pfizer officially joined the GLP-1 race in China after regulators approved ecnoglutide, developed by partner Sciwind Biosciences. The approval follows a deal worth up to $495 million for commercialization rights in the country. Sciwind will continue running development and manufacturing while Pfizer handles the commercial push. With China’s obesity rates climbing quickly, the market opportunity is enormous. Even in the GLP-1 gold rush, geography still matters.

💊 Roche’s Prized Pill Stumbles. Roche’s oral SERD giredestrant missed the primary endpoint in a phase 3 breast cancer study testing it alongside Pfizer’s Ibrance.

⚖️ Senators Probe Drug Pricing Deals. Senate Democrats led by Ron Wyden are demanding evidence that pharma companies’ “most favored nation” pricing deals will actually save Medicaid money.

💸 Lonza Spins Off Capsule Business. Lonza is selling its capsules and health ingredients unit to Lone Star Funds in a deal that could eventually exceed $4 billion.

🙌 AbbVie’s $350M Amylin Bet Shows Promise. A phase 1 trial of AbbVie’s amylin analog produced roughly 10% weight loss at 12 weeks.

📈 Xenon’s Epilepsy Drug Blows Away Phase 3. The company’s anti-seizure candidate cut seizure rates by more than 50% for some patients, sending shares up over 40%.

💰 Nemluvio Gets a Blockbuster Upgrade. Galderma now expects its inflammatory skin drug to exceed $4 billion in peak annual sales.

🌏 Taiwan Earmarks $755M for Drug Supply Security. The government is investing $755 million to strengthen domestic pharmaceutical manufacturing and reduce reliance on imports.

The FDA and uniQure are having the kind of argument that usually stays behind closed doors.

At the center is AMT-130, a gene therapy designed to slow Huntington’s disease by reducing production of the toxic huntingtin protein. Early data looked promising. After three years, treated patients appeared to decline about 75% slower than similar patients in a natural history database.

uniQure believed that was enough to start approval discussions.

The FDA disagreed.

Regulators want a randomized trial with a sham surgery control.

That means some patients would undergo anesthesia and a small scalp incision but receive no therapy.

uniQure argues the design raises ethical concerns. Patients would undergo brain surgery and potentially wait years before learning they received placebo.

The FDA says that comparison is exactly the point.

Huntington’s progression is highly variable, and many endpoints rely on physician assessments and patient-reported outcomes. When patients believe they received treatment, placebo effects can be powerful. Comparing treated patients to an external database does not capture that bias.

In other words: the agency does not dispute the numbers. It disputes the comparison.

The dispute quickly escalated into something more public.

An anonymous FDA official accused uniQure of presenting “distorted” comparisons to make the therapy look more effective. The company pushed back, calling the comments unprecedented and misleading.

Former FDA leader Janet Woodcock even weighed in, criticizing the agency’s stance.

Meanwhile, the broader rare disease community is watching closely. Several recent therapies have hit regulatory walls, and advisory committee meetings for rare diseases have dropped sharply over the past year.

The uniQure fight is really about a larger dilemma.

Gene therapies are expensive, invasive and often tested in tiny patient populations. Regulators must balance urgency against scientific certainty.

Too strict, and promising therapies die in development. Too flexible, and ineffective treatments slip through.

For Huntington’s patients, the debate is existential.

For the FDA, it’s about proving that hope still has to pass a control arm.

The timing added another layer to the story.

Just weeks after the uniQure standoff spilled into public view, Vinay Prasad announced he would step down as head of the FDA Center for Biologics Evaluation and Research, the division that oversees gene therapies and vaccines.

The agency never connected the two events. But the Huntington’s debate had already become one of the most visible flashpoints in the growing tension between regulators, biotech companies and rare disease advocates.

Whoever takes the CBER job next will inherit the same problem.

How much uncertainty should regulators tolerate when the disease has no cure and time is running out? 🤷

That’s the number of lives reportedly saved by LifeVac, a suction-powered anti-choking device that just received FDA clearance. The tool is designed as a last resort when standard choking protocols like the Heimlich maneuver fail. Essentially, it creates suction to pull a lodged object out of the airway. Yes, it looks suspiciously like a plunger for your face. But when it’s the difference between breathing and not breathing, aesthetics become negotiable.

Here’s what biotech Redditors are talking about:

✌️ Good riddance Prasad… but who replaces him?
Many commenters celebrated the news that Vinay Prasad will depart the FDA, arguing that approval standards seemed to shift unpredictably during his tenure. Several pointed to the uniQure and Moderna episodes as examples where companies felt blindsided by regulatory reversals. Others were less enthusiastic about the victory lap. Their concern: the next CBER chief could be even more unpredictable depending on the political winds in Washington.

💰 Wait… you guys still get bonuses?
Another thread asked biotech workers what raises or bonuses looked like this year in a tight hiring market. The most common answer landed around a 3–5% raise and roughly a 10% bonus. But plenty of employees said payouts came in below expectations. Several Danaher employees vented that bonuses missed targets after the company underperformed.

💼 Lilly Goes Direct to Employers. The company launched Employer Connect, a platform allowing businesses to offer Zepbound coverage directly through workplace health plans.

😂 SNL Roasts Amgen’s Otezla. A viral sketch portrayed the psoriasis drug as a mysterious ancient entity with no weaknesses and possibly its own timeline.

👁️ BCI Retinal Implant Raises $230M. Science is pushing its PRIMA brain-computer interface implant toward commercialization for patients with advanced macular degeneration.

🏢 Portal Opens Utah Biotech Hub. The venture firm is launching a 30,000-square-foot incubator in Salt Lake City to support early life science startups.

🕵 Atavistik Bio Raises $160M to Target the Hard-to-Reach
Atavistik Bio just secured $160 million to push its allosteric drug discovery platform forward. Instead of hitting the obvious “active” sites on proteins, the company targets hidden allosteric pockets that can still alter protein function. The approach may unlock targets traditional small molecules struggle to reach. Its lead candidate, ATV-1601, is headed toward human trials for hereditary hemorrhagic telangiectasia later this year. Same proteins. Sneakier binding strategy.

🌐 March 10, 2000 — The Dot-Com Bubble Peaks
The Nasdaq hit its all-time high during the internet boom, capping a 600% surge fueled by venture capital, startup mania and a lot of companies suddenly describing themselves as “internet platforms.” Two years later, the index had fallen 78% and roughly $5 trillion in market value evaporated. History rarely repeats perfectly. But when every company starts adding the same buzzword to its pitch deck, investors tend to get nostalgic for 2000.

The dot-com bubble reminds us that hype cycles can get loud before reality shows up with a calculator.

So if the industry starts describing everything as “AI-powered precision biology,” maybe keep one eye on the Nasdaq chart from 2000.

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

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