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Data on the primary endpoint of BioNTech’s/Duality Biologics’ pivotal Phase III study of its HER2 antibody-drug conjugate BNT323/DB-1303 are not yet public, However, BioNTech says that progression-free survival is better than with Roche’s second-line breast cancer therapy Kadcyla.
Experts from the six science academies united in EASAC have called for the immediate establishment of a transparent framework across the EU for the production of biotechnologically manufactured meat alternatives.
Belgian VIB spin-out MRM Health NV is using fresh funds raised in a €55m follow-on financing round to make its microbiome preparation MH002 licensable in an ongoing Phase IIb study for the indication ulcerative colitis. With €55m (US$64m) in Series B financing,
Swiss pharma major Novartis AG is investing money in the inhibition of the Parkinson’s target alpha-synuclein, which has already failed several times in clinical trials. The Swiss company is licensing the siRNA programme ARO-SNCA from Arrowhead Pharmaceuticals for US$200m.
California-based Cytokinetics Inc (CYTK) recorded a big jump in Nasdaq prices, at 40.45%, after presenting the results of its Phase III MAPLE-HCM study at the European Society of Cardiology Congress 2025.
Polpharma Biologics SA and MS Pharma SA have signed licensing agreements for Polpharma’s vedolizumab (PB016), ocrelizumab (PB018) and guselkumab (PB019) biosimilars in the Middle East and North Africa (MENA) region.
The US Roche unit Genentech Inc has signed a US$400 million licence deal with British NativeMS specialist OMass Therapeutics Ltd. Under the exclusive collaboration and licence agreement, Genentech intends to commercialise therapies for inflammatory bowel disease.
Sanofi SA has received FDA marketing approval for Wayrilz (rilzabrutinib). Unlike three existing causal treatments for immune thrombocytopenia (ITP), the oral drug inhibits both processes that drive the autoimmune disease. Analysts therefore predict peak sales twice as high as those of previously approved ITP drugs.
British company Sitala Bio Ltd, founded in 2021 by NLRP3 inflammasome expert Matt Cooper, is paying US$670m and giving up to 10% of its shares to Chinese company Shanghai Fosun Pharmaceutical Group Co. Ltd. in exchange for the development and marketing rights to the low-molecular-weight inflammation blocker FXS6837.
Eli Lilly, the US market leader in the lucrative diabetes and obesity space, is now challenging its competitor Novo Nordisk in the area of oral GLP-1 receptor agonists. Lilly’s orforglipron has met the primary endpoint of its registration study and is set to be submitted for approval in the United States.