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CBER's Director Quit Once, Came Back, and Now He's Gone for Good
Vinay Prasad, director of the FDA center that greenlights gene therapies, vaccines, and biologics, is leaving for good after a tenure defined by rare disease rejections, a vaccine memo that rattled the industry, and a formal workplace investigation. He was fired last July, then returned a few weeks later after FDA Commissioner Marty Makary vouched for him. This time, nobody's asking him back. During his watch, CBER blocked multiple rare disease therapies, refused to even review Moderna's flu vaccine application, and pushed out at least seven senior leaders. The center released groundbreaking frameworks for bespoke gene therapy approvals, but no successor has been named, leaving one of biotech's most critical regulatory bodies in a leadership vacuum.
Why it matters: CBER oversees roughly a fifth of the FDA's novel drug approvals, including the hottest areas of biotech innovation. A leadership vacuum here ripples through every company developing CAR-T therapies, CRISPR treatments, mRNA vaccines, and next-generation biologics.
Read more →Deals and M&A
Servier Drops $2.5 Billion on a One-Drug Biotech Focused on Kids' Brain Cancer
A privately held French pharma company just paid a 68% premium to acquire Day One Biopharmaceuticals, whose sole approved drug treats pediatric brain tumors. Ojemda pulled in $155 million in 2025 revenue, but Day One was still burning cash. Servier, which grew oncology sales 54.6% last year, is betting it can own the standard of care from first diagnosis to relapse in a market with almost no competition.
Read more →GSK Writes a $950 Million Check for a Drug That's Never Treated a Patient
GSK paid $950 million, all upfront, for 35Pharma's pulmonary hypertension drug HS235, which has only completed Phase 1 testing in healthy volunteers. The target: a multibillion-dollar market where Merck's Winrevair is already pulling in over $350 million per quarter. GSK is betting HS235's cleaner safety profile and metabolic benefits could carve out a massive second-mover advantage.
Read more →Bavarian Nordic's CEO Steps Down After Shareholders Torpedoed a $3.1 Billion Takeover
Denmark's biggest pension fund told a private equity consortium its $3.1 billion bid undervalued the mpox vaccine maker, and the deal collapsed at 60% acceptance. CEO Paul Chaplin, who backed the sale, is now leaving. With the stock trading below fair value estimates and the mpox boom fading, Bavarian Nordic becomes one of biotech's most interesting acquisition targets.
Read more →Pipeline and Platform Shifts
Flagship's $159 Million tRNA Bet Cuts 35% of Staff in One Day
Alltrna, the Flagship Pioneering-backed company engineering transfer RNA into drugs, just cut 19 people (its third layoff round). The 36 remaining employees are trying to push a completely novel drug modality into the clinic. It's part of a broader wave hitting Flagship's portfolio, where at least five companies have cut staff since mid-2025.
Read more →Vertex Trimmed Jobs While Posting $12 Billion in Revenue. Here's Why.
Biotech's most profitable company trimmed roles at its Providence, Rhode Island facility in what it called a functional reorganization. At a small fraction of headcount, it barely registers, but it reflects a broader industry pattern: even winners are pruning old priorities to fund expansion into pain, gene editing, and kidney disease. Vertex is guiding for nearly $13 billion in 2026 revenue.
Read more →CRO Shakeup
IQVIA Buys Charles River's Discovery Labs to Own Drug Development From Day One
For $145 million, IQVIA picked up five European discovery labs and a small-molecule AI platform from Charles River Laboratories. The deal gives the clinical trials giant something it never had: wet-lab discovery capabilities at the earliest stages of drug development, plus non-animal testing methods that regulators are increasingly demanding. Charles River, meanwhile, gets leaner and more profitable on purpose.
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