The U.S. FDA approved Corcept Therapeutics Inc.’s oral, selective glucocorticoid receptor antagonist, Lifyorli (relacorilant), nearly four months ahead of schedule for adults with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer. A short time after the agency approved Lifyorli, it cleared Denali Therapeutics Inc.’s Avlayah (tividenofusp alfa) under the accelerated approval pathway for mucopolysaccharidosis II, also called Hunter syndrome, ahead of the April 5 PDUFA date. Read More
Only a few months after reporting what it called “unprecedented” phase I data for its BCR-ABL1 tyrosine kinase inhibitor in chronic myeloid leukemia, Terns Pharmaceuticals Inc. agreed to an acquisition by Merck & Co. Inc. valued at about $6.7 billion. For Terns, the deal validates the decision last year to switch focus from its metabolic pipeline to oncology and, for Merck, it’s the latest move as the big pharma looks to shore up its offerings ahead of patent expirations for cancer blockbuster drug Keytruda (pembrolizumab). Read More
Maze Therapeutics Inc. continues its journey toward a pivotal program after sharing positive top-line data from the phase II Horizon study with MZE-829, an oral, small-molecule, dual-mechanism APOL1 inhibitor, in patients with broad APOL1-mediated kidney disease (AMKD). Read More
Chaos continues at the U.S. CDC and its Advisory Committee on Immunization Practices (ACIP) with the resignation of ACIP member Robert Malone and the impending deadline for the president to nominate a new CDC director following the dramatic exit last year of Susan Monarez and months of acting directors. Read More
Innovent Biologics Inc.’s efdamrofusp alfa (IBI-302) met the primary endpoint in the phase III Star trial in neovascular age-related macular degeneration (nAMD), and the Suzhou, China-based company will submit an NDA to China’s National Medical Products Administration. Read More
Repeated promotional claims Patrick Soon-Shiong made about Immunitybio Inc.’s Anktiva – such as “We have now discovered and developed this drug … approved for bladder cancer, but it actually can treat all cancers” – landed the Culver City, Calif., company a strongly worded warning letter from the U.S. FDA. Read More
The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) is to offer an early review of nonanimal data to give companies more confidence that evidence generated with new approach methodologies, such as organoids and microphysiological systems, will be accepted as part of marketing authorization applications. Read More
The U.S. FDA has issued a final order to reclassify optical diagnostic devices for melanoma detection and electrical impedance spectrometers from class III to class II, with special controls required. Read More
New hires and promotions in the biopharma and med-tech industries, including: A3P, Abivax, Adrax, Altathera, Camp4, Icecure, Idel, Leapfrog, Mentice, Mineralys, Over T, Protillion, Quidelortho, Realta, Umoja. Read More
Biopharma and med-tech companies raising money in public or private financings, including: Amani, Karyopharm, Outlook, Research Alliance, Rybodyn, Sernova, Sol-Gel, Turn, Virchow. Read More
Clinical updates for biopharma and med tech, including data readouts and publications: Aardvark, Belay, Biontech, Hoth, Innovent, Karyopharm , Ocugen, Prestige, Radiopharm, Spectral, Vantive. Read More
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Cephx, GE, Liviwell, Mars, Pharming, QT Imaging, Regeneron, Sanofi. Read More
