FDA issues complete response letter to Telesta’s BLA for MCNA
In this letter, the FDA communicated that an additional Phase 3 clinical trial for MCNA would be necessary to adequately establish MCNA’s efficacy and safety. The FDA also
ProBio has entered into an exclusive worldwide licensing agreement with South Korean biotechnology firm AbTis to develop and commercialise an early-stage therapeutic antibody asset.
Matinas BioPharma president and CEO Roelof Rongen said: "The encouraging preclinical data demonstrating MAT2501’s oral bioavailability and its targeted delivery of amikacin directly to the site of infection
Andexanet alfa, which is in Phase 3 clinical development in the U.S. and Europe, is designed to reverse the anticoagulant activity of Factor Xa inhibitors, includingEliquis (apixaban). Bristol-Myers
The conjugate is subsequently labeled with indium-111 (111In) and other potential radioisotopes for in vivo diagnostic imaging and treatment of cancers. Panacea Pharmaceuticals COO Steven Fuller said: "Panacea