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.
The latest global regulatory news, changes and updates affecting biopharma, including: CDER makes COVID-19 EUA data easier to find; NICE recommends use of CLL drug.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Celularity, Chinese Academy, Peptomyc, Precigen, Sangamo.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Antion, Astrazeneca, Biontech, Boston Pharma, Can-Fite, CR20, Dyadic, Exelixis, Gilead, GSK, Hoth, Indivumed, ITM, Ix, Matrisys, Merck & Co., Merck KGaA, Novamind, Novo Nordisk, Onk, Pfizer, Pyxis, Selexis, Spybiotech, Telix, University of Oxford, Veraxa, Xlife.
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