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 digital therapeutics market has surged during the pandemic and looks likely to markedly change health care long after the current crisis abates. The need for distance, limited in-person appointments, increased stress and mental health issues, and a more relaxed U.S. FDA approach have created the ideal environment for the rollout of therapies patients can use from home on their own time. Increasingly, clinical trials demonstrate the effectiveness of the new options and users praise the convenience.
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.
PARIS – Tilak Healthcare SAS is signing an ophthalmology partnership agreement with Novartis AG from Basel, Switzerland, to expand international distribution of its vision monitoring technology, Odysight.
Neurotech startup Nēsos Corp. has emerged from stealth with a novel approach for the treatment of rheumatoid arthritis. Using wireless earbuds, the technology delivers electrical fields to targeted areas of the brain to help regulate immune function. The company recently raised $16.5 million in a series A round to advance clinical development of its first e-immunotherapy product.
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.
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