Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4D Molecular, Acer, Cocrystal, Intellia, Lexicon, Pfizer, Relief, Rheacell, RDIF, Tenax.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Astrazeneca, Eurobio, Fortress, Gemini, Landos, Lumen, Mosaic, Q-State, Strongbridge, Surrozen, Xeris.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aim, Apexigen, Cassava, Covicept, Dialectic, Elicio, Entera, Legacy, Panther, Pharmather, Precirix, Takeda, Vaxart.
Advocates have continued to press for more widespread use of rapid antigen tests in the home as a primary instrument for returning to economic normalcy, and the FDA has granted an emergency use authorization (EUA) to Acon Laboratories Inc., of San Diego, for the company’s Flowflex rapid antigen test for at-home use. According to the FDA, Acon said the COVID-19 test will be produced at a rate of 200 million a month by February 2022, a clip that should go a long way toward restoring vigor to a lagging U.S. economy.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acon Labs, Amber Implants, Iotamotion, Nyxoah.
LONDON – The EMA set out the reasons for why it is diverging from the FDA on booster doses of Pfizer Inc.’s/Biontech SE’s COVID-19 vaccine, despite having reviewed the same data.
Francis Collins, perhaps one of the U.S.’ biggest cheerleaders for the promise of medical science, announced Oct. 5 that he will be ending his nearly 13-year tenure as NIH director by the end of the year, but he won’t be hanging up his lab coat. The 71-year-old Collins will continue to lead his research lab at the NIH’s National Human Genome Research Institute.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Allovir, Arcutis, Astrazeneca, Biontech, Celltrion, Coherus, Cour, Daiichi, Heron, Himalaya, Janssen, Kite, Moderna, Novartis, Pfizer, Relmada, Turning Point, Zosano.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aditxt, Aipharma, Alloy, Alzecure, April19, Dr. Falk, Enveric, Evenus, Lanier, Mindmed, Mydecine, Nabriva, Pacira, Regenerx, Renexxion, Secarna, Taysha, Vedanta, Vistagen.
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