China-based Hutchmed failed to get the U.S. Food and Drug Administration’s approval for the company’s proposed drug for pancreatic cancer.
FDA Action Alert: Immunocore, Reata, CTI, Gilead and Legend/JanssenBiologics 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 Melanoma
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.
The U.S. Food and Drug Administration approved Truseltiq (infigratinib) under the accelerated approval program for the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma (CCA) harboring an FGFR2 fusion or rearrangement.
2021 is shaping up to be another banner year for biotech companies. According to BioSpace, funds appear to be in near-endless supply as companies advance next-gen technologies and therapeutics for the health of all. BioSpace reviews a few raking in cash for their programs.
According to a research collaboration among UCLA investigators and Merck KGaA, berzosertib has shown promise for Covid-19 and is also being touted for the drug’s unusually broad effect in treating a range of cancers.
FDA Grants Full Approval of Deciphera Pharmaceuticals’ Qinlock for Treatment of Fourth-Line Gastrointestinal Stromal TumorApprovals, Breakthrough Therapy Designation, Clinical Studies, Fast Track Designation, FDA, FDA Oncology Center of Excellence, FDA/Regulatory, Gastrointestinal Stromal Tumors, Kinase Inhibitors, New Drug Approvals
The U.S. Food and Drug Administration approved Deciphera Pharmaceuticals Inc.’s Qinlock (ripretinib) for the treatment of adult patients with advanced gastrointestinal stromal tumor who have received prior treatment with 3 or more kinase inhibitors, including imatinib.
AstraZeneca and Merck & Co. announced that the U.S. Food and Drug Administration approved the kinase inhibitor Koselugo (selumetinib) for the treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas.
Merck & Co. Inc. is buying ArQule Inc. for $2.7 billion, seeking to tap into the drug developer’s experimental blood cancer therapy that targets genetic mutations.
AstraZeneca is significantly expanding the company’s footprint in China with the establishment of a global R&D center and launch of a $1 billion fund aimed at supporting that nation’s healthcare sector.
Bayer, Bristol-Myers Squibb and Ono Pharmaceutical teamed up to study the most common type of metastatic colorectal cancer.