Food and Drug Administration (FDA)
NEWS
In the CRL, the FDA indicated that the single registrational trial (106 Phase III) did not provide sufficient proof of efficacy to demonstrate benefit.
The FDA’s decision is based on positive results from two Phase III trials, the PROTECT and CONSTANT, on the drug’s efficacy.
The FDA’s Antimicrobial Drugs Advisory Committee voted 13 to 10 to recommend emergency authorization of molnupiravir. Read more about the authorization here.
ImmunoGen shares positive results from its Phase III SORAYA trial, which is evaluating the use of mirvetuximab soravtansine for treating ovarian cancer.
Ablaze has aligned itself with RayzeBio, giving Ablaze a solid start with an in-licensing agreement to bring Rayze’s products to the greater China market.
Early tests of Regeneron’s antibody cocktail show it isn’t as effective against Omicron while a separate tests of Eli Lilly’s antibody cocktail also demonstrated the same.
Omicron has caused the U.S. to install travel bans against several South African countries while vaccine makers rush to test their vaccines against it. For that news and more, continue reading.
Results from its GEM-3 trial on VYJUVEK demonstrated statistical significance in its ability to promote complete wound healing within six months compared to a placebo.
The latest data from Merck and Ridgeback Biotherapeutics’ MOVe-OUT trial on the use of molnupiravir to treat COVID-19 in adults has shown a lower efficacy than previously reported.
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