Following a recent string of emergency use authorizations (EUA) for their jointly developed COVID-19 vaccine, BNT-162b2, Pfizer Inc. and Biontech SE said Dec. 14 that results from an ongoing German trial have helped illustrate "the multiple arms of the immune system that are activated" by the product to fight SARS-CoV-2. Separately, Moderna Inc. raised to 200 million the number of doses of its COVID-19 vaccine candidate it will supply to the U.S. government.
Corrective and preventive action (CAPA) has a long and difficult history where med tech is concerned. Kathryn Merrill, the global quality/regulatory program director for Medtronic plc, of Dublin, said on a recent webinar that one of the main sources of uncertainty is that many in industry are not clear as to which circumstances dictate that a CAPA should be opened.
HONG KONG – Takeda Pharmaceutical Co. Ltd. has received Chinese approval for Takhzyro (lanadelumab), its fully human monoclonal antibody, delivered via subcutaneous injection, for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 and older.
PARIS – Cardiawave SAS has been granted authorization by the French National Agency for Medicines and Health Products Safety to extend its clinical trial in France and treat patients with calcific aortic stenosis (AS).
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: USTR seeking input on nations with poor IP protections; NICE sticks with ABI to evaluate PAD; Health Canada to extend COVID-19 flexibilities.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avelas Biosciences, Foldax.
The latest global regulatory news, changes and updates affecting biopharma, including: Health Canada to extend COVID-19 flexibilities; USTR seeking input on nations with poor IP protections.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Acceleron, Amag, Ascletis, Antengene, Astrazeneca, Avelas, Biontech, Codagenix, Daiichi Sankyo, EMD, Gamida, Gannex, Graphite, Legend, Merck KGaA, Mindmed, Open Orphan, Pfizer, Sobi.
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