Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Camurus, Guardant, Karl Storz, Pharmaessentia, Roche, Wave.
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Amgen, Biontech, Chemocentryx, Chiesi, Emalex, Forus, Kalvista, Moderna, Pharmaessentia, Pfizer, Precision, Sanofi, Snke, Teva, Veraxa.
Biopharma and med-tech companies raising money in public or private financings, including: Atossa, Cequr, Edesa, Humacyte, Ideaya, Kardigan, Nyxoah, Thruflo.
New hires and promotions in the biopharma and med-tech industries, including: Ambros, Aspen, Bighat, Dentsply, Fedora, Harbour, Oriva, Palisade, Phoremost, Poxel, Relmada, Viking, Vir.
Oricell Therapeutics Holdings Ltd.’s glypican-3 (GPC3)-targeted autologous CAR T therapy, Ori-C101, is heading into a confirmatory registration phase II trial in patients with GPC3-positive advanced hepatocellular carcinoma, positioning it as the first GPC3-directed immune cell therapy – and the first CAR T therapy for liver cancer – to reach that stage of development.
Takeda Pharmaceutical Co. Ltd.’s oral TYK2 inhibitor zasocitinib (TAK-279) demonstrated statistical superiority over Bristol Myers Squibb Co.’s first-in-class Sotyktu (deucravacitinib) in a top-line phase III Latitude Atlas readout of moderate to severe plaque psoriasis.
The industry is in support of the EU Biotech Act but says it needs to go further to restore Europe’s competitive position in biopharma. Instead of incremental adjustments, there should be wide-ranging change to create a system that supports the full lifecycle of drug development, from academic research and clinical development, to manufacturing and commercialization.
Biopharma deal value through the first five months of 2026 reached $135.36 billion, outpacing every prior year and topping 2025’s previous high of $103.92 billion. May was the year’s biggest month so far at $41.78 billion in transactions, making it one of the strongest individual months on record, and far outpacing April’s $13.87 billion. May 2026 comes in third in recent years in terms of deal value, after October 2023’s $44.91 billion and December 2022’s $42.45 billion.