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.
The administration of President Joseph Biden announced March 17 a $10 billion allocation of funds for testing to reopen schools in the final months of the current school year, a source of revenues that was provided by the recently passed $1.9 trillion American Rescue Plan. The news follows by one day a new FDA policy on screening tests that allows test developers to distribute tests designed to screen those who are asymptomatic without first validating the test for this use, although there are still questions as to whether this new push will yet again crimp vital testing supplies.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aptamer, Belmont Medical Technologies, Bioiq, Cytosorbents, Diamir, Emulate, Interpace, GE Healthcare, Leinco, Magventure, Mologic.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA sets up webpage, template for screening; Stryker’s STAR ankle exhibiting fracture risk.
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