Food and Drug Administration (FDA)
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Pfizer apparently hasn’t begun any combination trials in human beings of Paxlovid, and no reported human tests are using the drug in combination with other therapies.
The current president, CEO and board member, Keith Kendall, is departing Aquestive. He will be replaced by Daniel Barber, its current chief operating officer.
Axsome Therapeutics announced that it published the results of its Ascend Phase-II clinical trial of AXS-05 to treat Major Depressive Disorder in The American Journal of Psychiatry.
Cytokinetics filed with the SEC reporting that the FDA planned to hold an advisory committee meeting to review its New Drug Application (NDA) for omecamtiv mecarbil.
Dark Horse Consulting Group (DHC), based in Walnut Creek, Calif., submitted proposed draft guidance to the FDA for gene therapy safety.
COVID-19 would have claimed over 110,000 more lives in 2021 if vaccines weren’t available, according to a Pfizer-sponsored report on the first year of the U.S. vaccination program.
Orphazyme has several products with potential, with biopharma company KemPharm acquiring nearly all of the company’s assets and operations.
Akebia Therapeutics’s partner Otsuka Pharmaceutical Co. announced plans to terminate its global license agreements with Akebia for vadadustat.
In addition to lowering of blood sugar, Mounjaro also enabled patients to lower their weight by 15 to 23 pounds. The drug compared well to other diabetes medications including Novo Nordisk’s semaglutide.
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