China’s National Medical Products Administration (NMPA) has accepted for review Hightide Therapeutics Inc.’s NDA for HTD-1801 for type 2 diabetes, marking the Shenzhen-based company’s first NDA submission and a major step toward commercialization.
The strife-marked Duchenne muscular dystrophy (DMD) space drew forth another outspoken political figure in the shape of Sen. Ron Johnson (R-Wisc.), who said he was “enraged” by the U.S. FDA’s refusal to consider PTC Therapeutics Inc.’s Translarna (ataluren) for the treatment of nonsense mutation disease.
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Astrazeneca, BMS, Chiesi, Claritas, Daiichi, Immunitybio, Incyte, Johnson & Johnson, Junshi, MBX, Nanosonics, PMV, Precision, Protalix, Sangamo, Savara.
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Actuate, Baymedica, DT-Axis, Eledon, Etcembly, Fujitsu, Galecto, Inmed, Kuva Labs, Kyron.bio, Lisata, Newcelx, Servier, Zelluna.
Biopharma and med-tech companies raising money in public or private financings, including: AN2, Defence, Invea, Korro, Lyell, Relmada, SS Innovations, Telo Genomics.
Rapport Therapeutics Inc. added $20 million to its cash runway for its lead phase III oral seizure drug, RAP-219, through a potential $328 million license deal signed with Tenacia Biotechnology Co. Ltd.
Australia’s Telix Pharmaceuticals Ltd. is advancing a potential challenger to Novartis plc’s dominant prostate cancer radioligand therapy, Pluvicto (lutetium [177Lu] vipivotide tetraxetan), after reporting that the safety lead-in portion of its global phase III Prostact trial met its primary objectives.
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