Clinical updates for biopharma and med tech, including data readouts and publications: Aardvark, Belay, Biontech, Hoth, Innovent, Karyopharm , Ocugen, Prestige, Radiopharm, Spectral, Vantive.
Biopharma and med-tech companies raising money in public or private financings, including: Amani, Karyopharm, Outlook, Research Alliance, Rybodyn, Sernova, Sol-Gel, Turn, Virchow.
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.
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.
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.
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.
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.
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.
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).
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.
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