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Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, Appili, Biogen, Cytodyn, Dr. Reddy’s, Innovation, Kempharm, Nicox, Ocular, Onconova, Orchard, Polyphor, Takeda, Uniqure, Vertex, Ziopharm.
LONDON – The EMA has issued a positive opinion on Pfizer Inc./Biontech SE’s COVID-19 vaccine, BNT-162b2, becoming the first regulator to recommend a full marketing authorization, rather than approval for emergency use. The vaccine, now brand named Comirnaty, still has to go through the formality of being approved by EU member state governments, but the EU health commissioner, Stella Kyriakides, has said she expects roll out to start on Dec. 27.
The U.S. FDA has granted emergency use authorization (EUA) for thousands of products for the COVID-19 pandemic, and the agency is legally required to advise companies of their post-pandemic options for new marketing authorization. Conversely, companies that fail to deal with inventory for expired EUAs may find themselves in the crosshairs of the FDA, whistleblowers, and federal and state attorneys, suggesting that manufacturers of devices should have a plan for dealing with unused inventories once the public health emergency comes to an end.
CAJICA, Colombia – After a lengthy process, French spinal-cord implants manufacturer Implanet SA received marketing authorization by Cofepris, the Mexican health care surveillance agency, to distribute its Jazz platform in the Latin American country. Martillac, France-based Implanet is now looking to train surgeons in Mexico to use its Jazz platform that is designed to improve the treatment of spinal pathologies requiring vertebral fusion surgery.
A day after the FDA’s Vaccines and Related Biological Products Advisory Committee lent its support to Moderna Inc.’s COVID-19 vaccine, the agency granted it emergency use authorization (EUA). About 20 million doses will be delivered by the end of December and the rest in the first quarter of 2021, according to Moderna.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: DOJ arraigns test maker for investor fraud.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beroni Group, Canon Medical, Scone Medical Solutions.
The latest global regulatory news, changes and updates affecting biopharma, including: EMA updates on cyberattack; CDSCO extends import leniency; FDA’s obsolete human tissue rule on scrapheap.
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