Phase 3 Study News Today

Monday, the FDA informed Mesoblast Limited (NASDAQ:MESO) that following additional consideration, the available clinical data from its Phase 3 study MSB-GVHD001 appears sufficient to support submission of the proposed Biologics License Application (BLA) for remestemcel-L for pediatric patients with steroid-refractory acute graft versus host disease (SR-aGVHD). “We thank the agency for their collaborative approach. The responses and guidance from FDA are clear and provide us with a high le...

-- One oral presentation and five late-breaking posters accepted -- NEEDHAM, Mass., March 10, 2021 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ: CHMA), (“Chiasma” or the “Company”), a commercial-stage biopharmaceutical company utilizing its delivery platform technology to develop and commercialize oral therapies to improve the lives of patients with rare diseases currently treated with burdensome and painful injections, as evidenced by its recent approval of MYCAPSSA as ...

Process Begins for COVID-19 Vaccines Emergency Use by Angela Mohan on  February 22, 2021 at 11:13 AM Dr. Reddys has started the process with the Drugs Controller General of India (DCGI) for Emergency Use Authorization (EUA) of Russian vaccine candidate, Sputnik V. As part of the review process, Dr Reddys will present the safety profile of the Phase 2 study, and interim data of the Phase 3 study, which is expected to complete by February 21. Sputnik V, developed by the Gamaley...