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.
Keeping you up to date on recent developments in diagnostics, including: Data flaws sink current AI models for COVID-19 diagnosis; Smartphone-based gaze may provide a scalable, digital biomarker of mental fatigue; AI developed to predict disease based on genetic mutations; High blood fats, sugars alter antigen processing.
Shares of mRNA therapeutics specialist Translate Bio Inc. (NASDAQ:TBIO) fell 30.9% to $17.76 on March 18 over concerns about a new interim analysis of phase I/II data for its cystic fibrosis (CF) candidate, MRT-5005. Several dosing regimens of the inhaled candidate failed to improve a key measure of lung function vs. placebo, in contrast to an earlier readout on other doses tested in the ongoing study, called Restore-CF.
LONDON – Astrazeneca plc’s COVID-19 vaccine is safe and effective and the benefits well outweigh any risks, according to a review carried out by the EMA, following reports of blood clots in people who received the vaccine.
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