A change at the top of Sanofi

As we mentioned above, CEO Paul Hudson was let go by the board of the French pharma giant, or as Sanofi's announcement described it, Hudson's "Director mandate" was not renewed. Add that to your business lexicon for another way of saying,"You're fired."

Hudson is being replaced by Belén Garijo, the CEO of Merck KGgA. She starts on April 29.

As my STAT colleague Drew Joseph explains in his story this morning, Hudson was appointed Sanofi's CEO in 2019 with a mandate to ramp up the company's research programs and deliver more commercial blockbusters. Recent clinical setbacks have made that task more challenging, and now, Hudson is spending more time with his family.

Sanofi said that Garijo, a Spaniard who has run Merck KGga since 2021, "will bring an increased rigor" to preparing it for the future.

venture capital

European VCs launch biotech advocacy coalition

In an effort to boost capital for biotech startups and industry firepower in the E.U., a cohort of European life sciences investors — including Novo Holdings, Omega Funds, and Sofinnova Partners — is banding together to form the European Life Sciences Coalition.

The group argues that while Europe's science base is strong, its capital markets are not, STAT's Andrew Joseph writes. Of 67 E.U.-based biotechs that went public in the past six years, 66 listed on other exchanges, particularly in the U.S. The coalition is teaming up with the trade association Invest Europe and courting institutional investors like pension funds, and even floating the idea of a Nasdaq-style exchange based in the E.U.

"Today, we think it's the right time that venture capitalists and biotechs are invited to the table, and are a bit more vocal," Sofinnova partner Cedric Moreau told STAT.

vaccines

Prasad superseded FDA career staff on Moderna flu vaccine

FDA biologics chief Vinay Prasad overruled career staff and refused to accept Moderna's application for an mRNA influenza vaccine for adults 50 and older, escalating tensions between the agency and vaccine makers. STAT's Lizzy Lawrence broke the news that agency scientists were prepared to review the filing, but Prasad, who leads the Center for Biologics Evaluation and Research, signed an unusual refusal-to-file memo arguing that Moderna's trial used the wrong comparator, even though the company maintains the design had previously been cleared by FDA.

The move underscores a tougher, and increasingly unpredictable, stance on vaccines under an administration skeptical of mRNA technology.

"From a vaccine perspective, Prasad has injected an enormous dose of anxiety and lack of clarity into the process," said Peter Pitts, a former FDA associate commissioner. "That equals a lack of desire to invest in new and important technologies."

adam's biotech scorecard

FDA stance toughens on rare disease drugs, too

Speaking of Prasad, STAT's Adam Feuerstein suggests the regulator appears to be behind the rejection of a growing list of cell and gene therapies for rare diseases. (Sign up for Adam's weekly Biotech Scorecard newsletter here!)

While it's possible recent applications were flawed, companies including UniQure, Ultragenyx, Atara, and Capricor have also faced setbacks, suggesting a broader pattern. Long before joining the agency, Prasad has been skeptical of surrogate endpoints and single-arm studies. It seems like he's now applying a higher approval bar to gene therapies, even as FDA leadership publicly emphasizes flexibility for rare diseases.

rare disease

BridgeBio dwarfism drug beats BioMarin rival

BridgeBio Pharma said this morning that its oral drug infigratinib significantly accelerated growth in children with achondroplasia in a pivotal trial. The medicine outperformed BioMarin's injectable therapy, vosoritide, and positions the company to seek U.S. and European approval later this year, STAT's Damian Garde writes.

In a study of more than 100 children, the daily pill increased annualized growth by 2.1 centimeters versus placebo — a 1.74-centimeter adjusted difference — exceeding the 1.57-centimeter gain seen in BioMarin's registration study. This is BridgeBio's third straight Phase 3 win, and could allow the rare disease company to dominate market share in a field projected to surpass $4 billion annually.

That said, a debate continues within the dwarfism community over whether cosmetic height-focused treatments are necessary — with many saying achondroplasia isn't a disability.

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