Shares of Provention Bio Inc. plunged in trading after a Food and Drug Administration advisory committee narrowly supported the company’s diabetes prevention drug, teplizumab.
The U.S. Food and Drug Administration accepted for priority review the Biologics License Application submitted by Janssen Biotech Inc. for ciltacabtagene autoleucel (cilta-cel). The investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy is intended for the treatment of patients with relapsed and/or refractory multiple myeloma (MM).
Three members of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee published their objections to Biogen’s experimental drug aducanumab for Alzheimer’s disease in a JAMA article.
The U.S. Food and Drug Administration accepted for Priority Review Pfizer Inc.’s Biologics License Application for TicoVac, the company’s tick-borne encephalitis vaccine for active immunization to prevent TBE in individuals 1 year of age and older.
Bristol Myers Squibb reported that the company was abandoning the BCMA CAR-T therapy orva-cel and taking a $470 million write-off.
AstraZeneca spinout Albireo Pharma is moving closer to securing regulatory approval for the company’s treatment of pruritus in patients with progressive familial intrahepatic cholestasis (PFIC).
The U.S. Food and Drug Administration accepted for review Impel NeuroPharma’s 5O5(b)(2) New Drug Application (NDA) for INP104 for the acute treatment of migraine headaches with or without aura in adults.
The U.S. Food and Drug Administration accepted for priority review Pfizer Inc.’s Biologics License Application (BLA) for the 20-valent pneumococcal conjugate vaccine (20vPnC) candidate, as submitted for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults ages 18 years and older.
The U.S. Food and Drug Administration’s PDUFA dates for the last week of November 2020 include a review of Liquidia Technologies’ NDA for LIQ861 for the treatment of pulmonary arterial hypertension (PAH).
Shares of Alkermes were up in trading after the Ireland-based company announced the experimental schizophrenia drug ALKS 3831 was overwhelmingly supported by an advisory committee for the U.S. Food and Drug Administration.