Celltrion Inc. has bagged its first green light outside Asia for its COVID-19 monoclonal antibody Regkirona (regdanvimab) with an emergency use authorization in Brazil. Brazil’s Anvisa gave the EUA for the drug to treat high-risk adult patients, including those aged 65 or older, with mild and moderate COVID-19 symptoms on Aug. 11. The regulator reached its decision on the drug, also known as CT-P59, via a unanimous vote.
The FDA has authorized two batches of Johnson & Johnson’s COVID-19 vaccine from a troubled Emergent Biosolutions Inc. manufacturing facility to be made available under emergency use authorization (EUA) while determining that several other batches were unsuitable for use. While the FDA would not confirm the number of unsuitable batches, the newly authorized batches, however, can be used in the U.S. or exported.
There are now two FDA-backed monoclonal antibody COVID-19 treatments after the agency granted Glaxosmithkline plc (GSK) emergency use authorization (EUA) for single-dose sotrovimab to treat mild to moderate COVID-19 in adults and children as young as 12. Vir Biotechnology Inc. collaborated on the program.
With the global COVID-19 pandemic and variants raising expectations about the need for booster shots, more companies are jumping into the vaccine space. But unless those sponsors have been engaging “in an ongoing manner” with the U.S. FDA on developing the manufacturing process and clinical trial program for their vaccine candidates, their emergency use authorization (EUA) requests may be denied, according to a new FDA guidance on EUAs for COVID-19 vaccines.
The FDA’s operations have been badly hampered by the COVID-19 pandemic, but Jeff Shuren, director of the agency’s Center for Devices and Radiological Health (CDRH), said review times for most non-COVID product categories should resume their normal clip by the end of 2021. However, he acknowledged that the lag for in vitro diagnostics (IVDs) may not be fully resolved until 2022 because of the resources needed to review emergency use authorizations for tests for the SARS-CoV-2 virus.
HONG KONG – Celltrion Inc. continues its quest to take its Diatrust COVID-19 Ag Rapid Test overseas, after receiving the FDA’s emergency use authorization (EUA). The Incheon, South Korea-based company also submitted results of clinical trials in which 450 people throughout the U.S. were tested between February and March 2021 to the regulator, with the trial results currently under review.
The FDA reported a new streamlined pathway for diagnostic testing as part of a serial testing program using pooled samples, a pathway that should enable the further reopening of the economy. However, the FDA’s Tim Stenzel said April 21 that this new pathway relied on accumulated data for molecular testing, and that the agency lacks sufficient data to provide a similar mechanism for this use of antigen tests.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA says backlog of non-COVID applications will be cleared in eight weeks; NIH awards $33M for return-to-school efforts; Advamed tells CMS not to delay on MCIT.
“There is a big need for a drug in outpatients. If you could treat them and keep them out of hospitals, that would be important and play a big role in getting us through this pandemic,” Romark Laboratories LC’s CEO, Marc Ayers, told BioWorld.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA adds fingerstick sample to roster of COVID EUAs; NICE: Sonata system not backed by head-to-head studies.
