The FDA is mired in uncertainty with some staffers losing their jobs over the weekend and more potentially to come, vaccines and psychedelic therapies could be facing very different futures under newly confirmed HHS Secretary Robert F. Kennedy, Jr., Moderna continues its downward revenue slide and Merck, Regeneron, BMS and more face strong patent headwinds.
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President Trump has been on a staff cutting rampage since taking office, and this weekend, the hammer came down on an undisclosed number of FDA employees. The firings—which reportedly affected staffers within the FDA’s centers for food, medical devices and tobacco products—came days after Robert F. Kennedy Jr. was confirmed as HHS secretary.
One space that could have an ally in RFK Jr. is psychedelic therapies, which the new HHS boss has accused the FDA of “suppressing,” along with stem cell therapies. On the flip side, Kennedy is a well-known vaccine critic, though his confirmation didn’t affect the approvals of a pair of vaccines—one for GSK’s meningococcal shot and another for Bavarian Nordic’s chikungunya jab.
One notable vaccine maker, however, is struggling. Moderna reported Q4 and 2024 earnings last week, revealing full-year revenue of just over $3 billion—less than half of the nearly $7 billion the company brought in the year before. Adding insult to financial injury, Moderna is also laying off around 50 employees on its digital team.
Moderna isn’t the only company facing challenges. Several biopharmas, including Merck, Regeneron and Bristol Myers Squibb are facing patent headwinds that, according to William Blair, are the strongest they’ve been in nearly 15 years. It’s also a difficult climate in which to stay alive as a biotech, to which the 13 bankruptcies in 2024 can attest.
Finally, BioSpace launched a new NextGen podcast series this week, in which senior editor Annalee Armstrong speaks with execs from four of our NextGen Class of 2025 companies—starting with COUR Pharmaceuticals.
