The latest global regulatory news, changes and updates affecting medical devices and technologies, including: SUNSET rule suspended; Alliance calls for speedy nomination of FDA commissioner; Pandemic costly to TB effort; FDA announces May 4 patient data meeting.
CAJICA, Colombia – Countries in Latin America have joined those in Europe expressing mixed reactions about continuing their vaccination plans with the AZD-1222 SARS-CoV-2 vaccine developed by Astrazeneca plc and the University of Oxford, following reports of alleged adverse events.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BMS, Idorsia, J&J, Kiniksa, RDIF.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Hua, Oramed, Premas, RDIF, Revive, Strides, Vtv.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amyndas, Bluesky, Clovis, Eisai, Idera, Incyte, Merck & Co., Sarepta.
A U.S. Senate committee met March 18 to review the federal government’s response to the COVID-19 pandemic, during which former FDA commissioner David Kessler said the Trump administration’s vaccine contracts were expensive, but effective in ensuring a robust supply. Nonetheless, Sen. Chris Murphy (D-Conn.) said one vaccine manufacturer had recently voiced an interest in charging more on a per-dose basis for its vaccine, and suggested that the cost of booster shots should perhaps be examined anew by the Biden administration.
HONG KONG – SK Bioscience Ltd.’s shares soared as much as 30% in their KOSPI board debut on Thursday. The 22.95 million shares on offer opened at ₩130,000 (US$115.08) and were trading at ₩169,000 by the close of the trading day, raising ₩1.5 trillion, or $1.33 billion. SK Bioscience had priced the shares at the top of the ₩49,000 to ₩65,000 range.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA grants de novo for Biofire multianalyte assay; No injuries or deaths associated with Acist Kodama recall; Supreme Court to hear assignor estoppel case; Cardiac rehab bill resurfaces in U.S. House.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biofire, Boston Scientific, Braintale, Catalyst, Life Spine, Stimdia.
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