The FDA has posted two draft guidances for the transition of policies from the pandemic to more normal times. One of these is the long-awaited draft for transitioning a device from an emergency use authorization (EUA) to a conventional premarket status, which offers a 180-day grace period for an EUA after the agency identifies a date on which the EUA will be terminated.
LONDON – The latest cut of data from a study tracking the COVID-19 pandemic in near real time in Scotland indicates the Omicron variant of SARS-CoV-2 is two-thirds less likely to result in hospitalization than the Delta variant.
With Omicron spreading rapidly, U.S. COVID-19 vaccine producers are facing increasing pressure to up their production and to do more to ensure their vaccines are accessible globally.
Astrazeneca plc has confirmed it is working with Oxford University to produce a vaccine against the Omicron variant of the SARS-CoV-2 virus. The Cambridge, U.K.-based pharma was one of the first to get a COVID-19 vaccine okayed by regulators, after acquiring rights to the shot from Vaccitech plc, a spin-out from Oxford University’s Jenner Institute specialist vaccine unit.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avacta, Phillips, Sight Sciences.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: BD, Carestream Dental, Cue Health, Envista, Everly Health, Ixensor, Lucira, Nevro, Nalu.
The largest swings in stock price in 2021 can partly, or mostly, be attributed to the COVID-19 pandemic, as biopharma solutions either saved the world or fell short, depending on the newest emerging variant. Those ups and downs have led the BioWorld Biopharmaceutical Index to a nearly flat position in comparison with the beginning of the year. It is up by only 0.33%. The Nasdaq Biotech Index, however, is up 4.6%, while the Dow Jones Industrial Average, representing the broader markets, is up by 14.13%.
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