According to the latest annual overview published by trade association France Biotech, French med-tech, biotech, and e-health companies have adapted rapidly to the COVID-19 pandemic. Many French health care companies have faced real difficulties in all areas of procurement, R&D, and sales. As of February, a quarter of these French companies were redirecting their research activity towards the coronavirus.
Most of the med-tech companies doing business during the COVID-19 pandemic are experienced and already have their FDA compliance systems in place. However, Dennis Gucciardo, a partner at the D.C. office of Morgan, Lewis & Bockius LLP, told BioWorld that while the FDA will give industry sufficient time to transition their emergency use authorizations (EUAs) to conventional premarket filings, the cost of setting up a quality management system may be greater than some current EUA holders are willing to bear.
Data from two Novavax Inc. clinical trials show its COVID-19 vaccine had 100% protection against severe disease, including hospitalization and death, paving the way for an emergency use authorization submission in the U.S. Mild and moderate COVID-19 was dramatically reduced in both studies, according to the data, and some efficacy was confirmed in variant strains.
DUBLIN – Apeiron Biologics AG reported March 12 that APN-01, recombinant angiotensin converting enzyme 2 (ACE2; alunacedase alfa) failed to attain the primary endpoint of lowering all-cause death or the need for invasive mechanical ventilation in hospitalized patients with severe COVID-19.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Eisai, J&J, RDIF, Sanofi, Takeda.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Atossa, Bergenbio, Boehringer, Harbour, Inhibrx, Novavax, Noxxon, Sanofi, Swedish Orphan, Translate.
What started with Austrian regulators suspending use of one batch of Astrazeneca plc’s COVID-19 vaccine has expanded into precautionary holds in Denmark and other EU countries as PRAC, the EMA’s safety committee, investigates whether blood clots, which have resulted in at least two deaths in Europe, are connected to the vaccine.
The U.S. FDA has granted emergency use authorization (EUA) to Breath Direct Inc. for its BDR-19 critical care ventilator for the treatment of critical care patients with respiratory insufficiency. Initial shipments of the device are expected within weeks. The EUA marks a major milestone for the fledgling Long Beach, Calif.-based company, which was started by medical device entrepreneur Darren Saravis in the early days of the pandemic.
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