Food and Drug Administration (FDA)
NEWS
Murepavadin is the lead, pathogen specific, Phase III antibiotic belonging to the OMPTA family and potentially the first drug of a new class of antibiotics against Gram-negative bacteria in more than 50 years
MediciNova, Inc. announced that the U.S. Food and Drug Administration has completed its review of the protocol and determined that MediciNova may proceed with a Phase 2b/3 clinical trial of MN-166 in amyotrophic lateral sclerosis.
Novartis will use a priority review voucher to expedite review of the treatment that could hit blockbuster status within two years of launching.
TLC announced the successful completion of its End-of-Phase II meeting with the U.S. Food and Drug Administration (FDA) on receiving guidance, and discussing the clinical and regulatory pathway for a potential U.S. approval of TLC599, a BioSeizer® liposomal formulation of dexamethasone sodium phosphate for the treatment of knee osteoarthritis.
Cambridge, Mass.-based Alnylam Pharmaceuticals indicated that its ENVISION Phase III trial of givosiran was positive for acute hepatic porphyria (AHP).
The FDA’s approval marks the first personalized treatment targeting susceptible FGFR genetic alterations for patients with metastatic bladder cancer.
Developing a Human Factors Validation Plan with Consideration for the Digital Health Marketplace
Polyphor AG announced that the US Food and Drug Administration has designated murepavadin as a Qualified Infectious Disease Product in four additional indications; hospital-acquired bacterial pneumonia, acute bacterial skin and skin structure infection, bloodstream infection and complicated intra-abdominal infection.
It should be no surprise that the Washington, DC and Baltimore areas are considered strong for life sciences. This is BioSpace’s BioCapital Community Hotbed.
JOBS
IN THE PRESS