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Ones of the coolest parts of this job is getting the chance to discuss cutting-edge science and technologies with the people behind them. You can see plenty of those conversations in this week’s lineup. — Amber Tong
Merck’s C-cuite shakeup
On the heels of Roger Perlmutter and Ken Frazier’s departure, Michael Nally has left his chief marketing officer post at Merck for greener pastures. Reportedly in the running for the CEO job as Frazier retires, Nally ultimately lost out to CFO Robert Davis, who is now leading a fresh C-suite with Dean Li as R&D chief and Frank Clyburn, inaugural president of the global oncology business and most recently chief commercial officer, in Nally’s previous position.
Eli Lilly stirs Alzheimer’s controversy
Nothing drums up excitement and controversy quite as instantly and intensely as Alzheimer’s — as Eli Lilly has once again demonstrated with the presentation of mixed results from its Phase II trial of donanemab. While the pharma giant heralded a statistically significant result for the unconventional primary endpoint it chose, even the optimists were cautious to jump to conclusions while critics homed in on the meh numbers on the secondary endpoints (which represented more traditional metrics used in previous studies) and side effects. Lilly, though, maintained the data were “tremendously important” and is upbeat about its upcoming pivotal before heading to regulators — by which time they may also have a precedent in Biogen’s aducanumab.
FTC pledges pharma M&A crackdown
Rebecca Kelly Slaughter didn’t mince words in calling out pharma megamergers. Now as FTC’s acting chair, she’s vowing to “rethink” the antitrust watchdog’s review approach by setting up an international working group to scrutinize these deals and vowing to consider new proposed deals in light of conduct like price fixing, reverse payments and other regulatory abuses. The group will comprise state attorneys general, the Department of Justice, as well as UK, European and Canadian regulatory counterparts. At least one big buyout may be on the line.
FDA holds the line on Covid-19 antibodies
Emerging variants of the coronavirus are threatening to undermine the three antibody treatments from Eli Lilly and Regeneron that have been authorized for emergency use, and the FDA is vowing to stay on top of it. The US government is no longer distributing Lilly’s bamlanivimab into California, Arizona and Nevada because of the prevalence of a viral variant, acting commissioner Janet Woodcock told a meeting of doctors. And after releasing a letter requiring the two companies to monitor the activities of their drugs, her agency spelled out the available data on the performance of bamlanivimab alone, bamlanivimab plus etesevimab, and the imdevimab/casirivimab cocktail.
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