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.
In addition to the four COVID-19 vaccines it has provisionally approved, Australia’s Therapeutic Goods Administration (TGA) is recommending that two more vaccines – Sinovac Biotech Ltd.’s Coronavac and Astrazeneca plc-Serum Institute of India’s Covishield – be considered “recognized vaccines.”
DUBLIN – Redhill Biopharma Inc. is claiming a 62% relative reduction in day 42 mortality from COVID-19 among hospitalized severe patients who received its oral drug, opaganib, as compared with those on placebo. It is also reporting a shorter median time to discharge (10 days vs. 14 days) and a higher proportion of patients on treatment being able to breathe unassisted by day 14 (77% vs. 63.5%).
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