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Welcome back to Endpoints Weekly, your review of the major biopharmaceuticals headlines of the week. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints weekly. New to Endpoints? Register here.
One of the most interesting parts of this job is getting the chance to discuss cutting edge science and technology with the people behind them. You can see a lot of those conversations in this week’s lineup. – Amber Tong
Merck’s C-baked overhaul
On the heels of Roger perlmutter and Ken frazier Departure, Michael nally left his role as Marketing Director at Merck for Greener Pastures. Apparently in contention for CEO position as Frazier retires, Nally ultimately lost to CFO Robert davis, who now runs a new C-suite with Dean li as R&D manager and Frank Clyburn, first president of the global oncology business and most recently Commercial Director, in Nally’s previous role.
Eli Lilly stirs up controversy over Alzheimer’s disease
Nothing sparks excitement and controversy as instantly and intensely as Alzheimer’s disease – like Eli lilly has once again demonstrated with the presentation of mixed results from its Phase II trial of donanemab. While the pharmaceutical giant announced a statistically significant result for the unconventional primary endpoint it chose, even optimists have been cautious about jumping to conclusions as critics have focused on the meh numbers over the secondary endpoints ( which represented more traditional measures used in previous studies) and Side Effects. Lilly, however, maintained the data was “extremely important” and is optimistic about its next pivot before heading to regulators – at that point it could also have precedent in Biogen’s aducanumab.
FTC promises crackdown on pharmaceutical mergers and acquisitions
Rebecca Kelly Slaughter did not mince words when calling the pharmaceutical mega-fusers. Now as Acting President of the FTC, she pledges to ‘rethink’ the antitrust watchdog review approach by creating an international task force to review these agreements and promising to review any new offers on offer. in light of behaviors such as pricing, reverse payments and other regulatory abuses. The group will include state attorneys general, the Department of Justice, as well as UK, EU and Canadian regulatory counterparts. At least one big buyout may be in play.
FDA holds line on Covid-19 antibodies
Emerging variants of the coronavirus threaten to undermine all three Eli Lilly and Regeneron antibody treatments that have been cleared for emergency use, and the FDA is committed to staying on top. US government no longer distributes Lilly’s bamlanivimab in California, Arizona and Nevada due to prevalence of viral variant, Acting Commissioner Janet Woodcock said a meeting of doctors. And after issuing a letter asking the two companies to monitor the activities of their drugs, his agency clarified the available data on the performance of bamlanivimab alone, bamlanivimab plus etesevimab and the imdevimab / casirivimab cocktail.
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