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.
Twelve years on from the World Health Organization formally raising the alarm, antimicrobial resistance continues to grow, and despite numerous public and private incentives and initiatives, the pipeline of antibiotics in development is thinner than ever.
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