The FDA’s device center has generated a raft of warning letters for products related to the COVID-19 pandemic, and released another six such letters for the week of Aug. 9. However, the ostensible justification for those warnings varies considerably, as does the elapsed time between the date of the warning letter and its issuance on the FDA’s warning letter webpage.
LONDON – Stopping people under 40 from receiving Astrazeneca plc’s COVID-19 vaccine has put an end to the serious blood-clotting syndrome associated with the product, with no new cases in the U.K. for the past four weeks, according to an expert panel of hematologists.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akouos, Belief, Dermavant, Fibrogen, GW, Innocare, Lantern, Merck, Phasebio, Reata, Roivant, SFJ.
Sinovac Biotech Ltd. said booster shots of its Coronavac vaccine against SARS-CoV-2 induce strong immune responses in adult and elderly populations following a considerable loss of antibodies six to eight months after completing the current two-dose regimen.
SK Bioscience Ltd. has won approval from the South Korean Ministry of Food and Drug Safety (MFDS) to begin a phase III trial for its COVID-19 vaccine candidate GBP-510, making the recombinant protein antigen vaccine the first domestically developed candidate to make it to late-stage testing. “We aim to begin the phase III trials within August and to have the data ready by early 2022,” a company spokesman told BioWorld.
Rick Bright, who filed a whistleblower complaint last year against the U.S. Department of Health and Human Services (HHS) after he was removed from his position as director of the Biomedical Advanced Research and Development Authority (BARDA), reached an undisclosed settlement with HHS, the U.S. Office of Special Counsel reported Aug. 9.
MRNA’s the thing and special purpose acquisition company (SPAC) Environmental Impact Acquisition Corp. is following as it will merge with privately held mRNA-developer Greenlight Biosciences Inc.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Phase Scientific.
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