Agency biologics investigator questioned site classification downgrades and belated response to Merck & Co. plant informant’s concerns.

The US FDA has accepted the Swiss biotech's "huge" NDA file for daridorexant which the company hopes will be more successful on the insomnia market than other DORA sleep treatments such as Merck & Co's Belsomra.

Bharat Biotech’s COVID-19 vaccine has shown 80.6% efficacy in interim data from Phase III clinical trials, slightly better than the 79.3% reported by Sinopharm and significantly higher than Sinovac’s 50.6% for their vaccines based on similar technology. Supply deals are already on the way, with Brazil having signed up for 200 million doses.

ReWalk plans to use the proceeds to fund sales, R&D and reimbursement expenses related to its ReStore and Personal 6.0 devices as it continues to face negative effects of pandemic.