At a session of the American Association for Cancer Research Virtual Annual Meeting II, multiple FDA regulators gave presentations on various topics to help drug companies understand the ever-evolving oncology regulation.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: EMD Serono, Genprex, Medivir, Merck, Sinovac, Tizona, Viracta.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Fulcrum, GBT, Hemoshear, Imara, Innate, Mayne, Medigene, Neurorx, Novartis, Relief, Philogen.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Immunovative, Mirror Biologics, Karuna, Karyopharm, Marker, Myovant, Novaremed, Pharmacyclics, Polynoma, Reneo, Renibus, Santhera.
Xpovio (selinexor), an oral selective inhibitor of nuclear transport from Karyopharm Therapeutics Inc., of Newton, Mass., received FDA approval today for treating adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. Xpovio will be available immediately in the U.S., the company said, and, due to COVID-19 restrictions, the launch will be a virtual one.
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.
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