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.
U.S. Food and Drug Administration Accepts for Priority Review Taiho Oncology’s New Drug Application for Futibatinib for Cholangiocarcinoma
Accepted NDA, Cholangiocarcinoma, Clinical Trials, FDA/Regulatory, FGFR2 gene, Gene fusions, New Drug Applications, PDUFA, Priority Review Status, R&D, Small-Molecule InhibitorsTaiho 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.
FDA Action Alert: Immunocore, Reata, CTI, Gilead and Legend/Janssen
Biologics License Application (BLA), Chronic Kidney Disease, Clinical Trials, FDA/Regulatory, Genetic Mutations, Gilead, Kinase Inhibitors, Multi-drug resistant HIV-1 infection, Multiple Myeloma, Myelofibrosis, PDUFA, Priority Review Status, R&D, Uveal MelanomaLegend 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 says FDA could deny expanded use of arthritis drug for eczema
AbbVie, Aopecia Areata, Arthritis, Blockbusters, Clinical Trials, Eczema, Eli Lilly, FDA, Hair Loss, Hospitalized COVID-19 Patients, Janus Kinase (JAK) Inhibitors, New Indications, Pfizer, Priority Review Status, R&D, Rivalries, TherapeuticsEli 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.