One day after BridgeBio Pharma struck a nearly $1 billion oncology pact with Bristol Myers Squibb, the California-based company announced plans to sell a priority review voucher received in February.
Taiho Oncology Inc. and Taiho Pharmaceutical Co. Ltd. announced that the U.S. Food and Drug Administration accepted for priority review the New Drug Application (NDA) for futibatinib in the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma (CCA) harboring FGFR2 gene rearrangements, including gene fusions.
Shares of bluebird bio fell in trading on March 7 after the company revealed its dire financial straits.
Legend Biotech has a target action date of February 28 for the company’s BLA for ciltacabtagene autoleucel (cilta-cel) for adults with relapsed and/or refractory multiple myeloma. The BLA was submitted by Legend’s collaboration partner, Janssen Biotech Inc., a Johnson & Johnson company.
Eli Lilly said on Jan. 28 the company expects the U.S. Food and Drug Administration to decline the approval of expanded use of the rheumatoid arthritis drug Olumiant as a treatment for adults with moderate-to-severe eczema.
The U.S. Food and Drug Administration agreed to place Regeneron Pharmaceuticals Inc.’s Biologics License Application (BLA) for the Covid-19 drug REGEN-COV under priority review with a target action date of April 13, 2022.
Moderna Inc. completed the real-time review process needed for a full approval for the company’s Covid-19 vaccine in people aged 18 years and older.
Ipsen’s New Drug Application (NDA) for palovarotene – an oral, investigational, selective RARγ agonist for the prevention of heterotopic ossification (new bone formation) as a potential treatment option for people living with the progressive disabling and ultra-rare genetic disorder fibrodysplasia ossificans progressiva (FOP) – was accepted by the U.S. Food and Drug Administration.
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).
Pfizer Inc. began testing fully vaccinated adults over 65 in a new study that uses the company’s 20-valent pneumococcal conjugate.