Shares of bluebird bio fell in trading after the company announced that the sickle cell disease gene therapy treatment bb1111 will not be submitted to the U.S. Food and Drug Administration for two more years.
Spectrum Pharmaceuticals announced that an inspection of the Hanmi Bioplant in South Korea will be necessary before the U.S. Food and Drug Administration can approve the company’s Biologics License Application for Rolontis (eflapegrastim).
Junshi Biosciences, based in Shanghai, China, announced that an Independent Monitoring Committee (IDMC) decided the company’s Phase III JUPITER-02 trial had met the pre-specified primary endpoint at the interim analysis.
Bristol Myers Squibb and bluebird bio are eying a potential quick approval for a CAR-T treatment for multiple myeloma after the U.S. Food and Drug Administration accepted the Biologics License Application under priority review for idecabtagene vicleucel.
ADC Therapeutics SA announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration for loncastuximab tesirine (Lonca) for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma.
bluebird bio Inc. announced updated results from the clinical development program for the company’s investigational elivaldogene autotemcel (eli-cel, Lenti-D) gene therapy in patients with cerebral adrenoleukodystrophy (CALD), including long-term results from the Phase 2/3 Starbeam study and data from the Phase 3 ALD-104 study.
The U.S. Food and Drug Administration’s approval-review schedule for August includes the Biologics License Application for Bristol Myers Squibb and Juno Therapeutics’ lisocabtagene maraleucel (liso-cel) for relapsed or refractory large B-cell lymphoma after at least two previous therapies.
Shares of Biogen jumped more than 11 percent after the company announced the U.S. Food and Drug Administration accepted the Biologics License Application (BLA) for aducanumab, an investigational treatment for Alzheimer’s disease.
The U.S. Food and Drug Administration issued a Complete Response Letter regarding DBV Technologies’ Biologics License Application (BLA) for investigational Viaskin Peanut (DBV712), a non-invasive, once-daily epicutaneous patch to treat peanut allergies in children ages 4 to 11 years.
Bristol Myers Squibb and bluebird bio announced the submission of their Biologics License Application (BLA) to the U.S. Food and Drug Administration for idecabtagene vicleucel for the treatment of adult patients with relapsed and refractory multiple myeloma.
