The Food and Drug Administration will attach a warning for Guillain-Barré syndrome to the Johnson & Johnson vaccine. Federal regulators have found that the risk of developing the condition is three to five times higher among people who have received the vaccine, though the overall chances are still very low. (The New York Times)
Generic manufacturers of the Zantac heartburn pill won’t face lawsuits over the drug’s link to cancer, even though brand-name drugmakers will. The pills were recalled in 2019 after the FDA found that some contained high levels of a known carcinogen. (STAT)
Novo Nordisk will pay $100 million upfront for Prothena’s ATTR amyloidosis pipeline. Prothena’s top candidate is the PRX004 antibody, an anti-amyloid immunotherapy. (Endpoints News)
Acting FDA commissioner Dr. Janet Woodcock has called for a watchdog review of the agency’s relationship with Biogen leading up to the controversial approval of Aduhelm. FDA officials reportedly worked with Biogen executives to get the drug to market, a STAT investigation found. (Politico)
Israel is partnering with NRx Pharmaceuticals to commercialize its homegrown COVID-19 vaccine, BriLife. NRx has arranged for rapid Phase 2b/3 testing in Israel, Georgia and Ukraine, which will include tens of thousands of volunteers. (Reuters)
