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.
BEIJING – The current speed of new developments in the 2019-nCov outbreak is illustrated by a Jan. 28, 2020, press conference in Munich, where Andreas Zapf, head of the infection task force in the Bavarian ministry for health and food safety, briefed reporters on the first confirmed German case.
The U.S. FDA’s emphasis on internationalized regulations continues with the agency’s adoption of ISO 14971, the risk management framework published by the International Organization for Standardization (ISO). The FDA said it will accept declarations of conformity to the previous edition until December 2022, giving device makers roughly three years to update their systems.
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