Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biontech, Pfizer.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbvie, Brickell, Bristol Myers, Celltrion, Denali, G1, Genetx, Inhalon, Jounce, Minervax, Timber, Ultragenyx.
Brii Biosciences Ltd. shared interim data from a phase III trial of its neutralizing monoclonal antibody (mAb) combination therapy for SARS-CoV-2, BRII-196 and BRII-198, that showed a 78% reduction in the risk of hospitalization or death in patients receiving single dose of the cocktail.
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.
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