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This author has not written his bio yet.
But we are proud to say that Victor Kotsev contributed 17 entries already.
Italy’s Newron Pharmaceuticals has disclosed that the FDA kept U.S. enrollment in a Phase 3 trial of its schizophrenia drug evenamide on hold, citing five deaths across all the drug’s clinical studies. The company will ask the agency to lift the hold by screening patients for hidden heart-rhythm disorders, including with genetic tests.
Genmab and AbbVie’s bispecific antibody epcoritamab, added to R-CHOP chemoimmunotherapy, cut the risk of progression or death by 51% in a Phase 3 trial in newly diagnosed diffuse large B-cell lymphoma (DLBCL).
Novo Nordisk will pay China’s Jiangsu Hengrui Pharmaceuticals $300 million (€264 million) upfront, in a deal worth up to $2.6 billion (€2.3 billion), for rights outside Greater China to HRS-1596, an experimental obesity and diabetes pill that the companies say could be taken once a week.
European biotech and clinical-research figures broadly agree with nine major drugmakers whose chairs signed a letter urging governments to reward new medicines better, but say the fixes go well beyond price.
Beacon Therapeutics’ gene therapy laru-zova met its U.S. pivotal endpoint in X-linked retinitis pigmentosa, while results on the trial’s separately designated European primary efficacy measure were less clear-cut.
Novartis has stopped developing its TREM2 antibody VHB937 (lifonebart) in amyotrophic lateral sclerosis (ALS) after the 251-patient Phase 2 ASTRALS trial missed its primary and secondary endpoints, and shortly after Axoltis Pharma suffered a similar Phase 2 setback.
Danish biotech ResoTher Pharma’s heart attack drug RTP-026 was well tolerated and showed early efficacy signals in a 66-patient Phase 2a trial, according to results announced Sept. 14 that clear a key condition for Swedish-listed Hunter Capital RTO 1’s planned reverse acquisition of the company.
GSK has agreed to acquire full global rights to a preclinical trispecific T-cell engager for multiple myeloma from China-based Chimagen Biosciences in a deal worth up to $750 million (€650 million), its second purchase from the company in under two years.
CDMO company Northway Biotech has opened a €61 million cell therapy and personalized medicine center in Vilnius that is being qualified for GMP manufacturing, and the company says it expects a manufacturing authorization from Lithuania’s State Medicines Control Agency within six months.
Italian pharma Menarini Group has licensed European rights to bofanglutide for obesity and excess weight, a long-acting GLP-1 receptor agonist from China’s Gan & Lee Pharmaceuticals dosed once every two weeks, for €62 million upfront, up to €664 million in milestones, and “double-digit” royalties. Menarini will handle regulatory submissions and commercialization across 39 European markets.