The FDA has issued two new approvals, one for a cell-based pandemic influenza A (H5N1) vaccine and the other is the first approval for treating peanut allergy.
PERTH, Australia – Australian stem cell therapy company Mesoblast Ltd. has filed the final module of its rolling BLA submission for its allogeneic mesenchymal precursor cell therapy, remestemcel-L, after it showed strong survival rates in children with acute steroid-refractory graft-vs.-host disease (aGVHD).
HONG KONG – Aiming to increase the financial stability of the national health care insurance system, Japan has announced a list of 17 drugs for which prices will be reduced.
LONDON – Brexit finally becomes a reality at midnight central European time on Jan. 31, but for the life sciences industry uncertainty continues, as the U.K. enters an 11-month transition phase during which the terms of its future relationship with the EU must be negotiated.
Medtronic plc has gained CE mark approval for its Cobalt and Crome portfolio, the company’s first implantable cardiac defibrillators (ICDs) and cardiac resynchronization therapy-defibrillators (CRT-Ds) to offer connected health via Bluesync technology. The portfolio will be rolled out on a country-by-country basis throughout Europe, with initial implants in select countries to begin soon.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) looked with favor on a bucketload of would-be drugs, issuing positive opinions for the European Commission to consider across a range of indications.
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