HONG KONG - Mumbai-based Glenmark Pharmaceuticals Ltd. has been granted manufacturing and marketing approval for the launch of its antiviral drug, favipiravir, for the treatment of mild to moderate COVID-19, a move it deems a “landmark development for COVID-19 patients in India.”
A second attempt by Nabriva Therapeutics plc to win U.S. approval for the antibiotic Contepo (fosfomycin) has been undone by COVID-19. Manufacturing issues stymied the original NDA. This time, restrictions of FDA staff travel to Europe sunk the venture, leading to a new complete response letter (CRL) for the candidate as a potential treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Altimmune, Basilea, Bio-Thera, Deciphera, Merck, Nabriva, Regeneron, Resverlogix, Sanofi.
Evoke Pharma Inc., of Solana Beach, Calif., which has struggled in the past year through troughs in its stock price and doubts from the FDA in its quest for approval for Gimoti (metoclopramide), was vindicated today as the FDA approved the treatment for adults with acute and recurrent diabetic gastroparesis.
Smart assisted surgery company Naviswiss AG, of Brugg, Switzerland, has gained U.S. FDA clearance for its miniature navigation technology for hip replacement surgery. The hand-held system, with an open platform that supports all implant vendors, is being offered on a fee per-use basis.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acasti, Ampio, Ascentage, Beigene, Innovent, Nymox, Ovid, Plakous, Redhill, Regeneron, Sanofi.
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