Several South Korean biotech and biopharmaceutical companies completed IND submissions or won nods to start clinical trials in either the U.S. or South Korea, including SK Bioscience Co. Ltd., Genosco Inc., Pimedbio Inc., Sillajen Inc. and Ami Pharm Co. Ltd.
The vaccine dominoes continue to fall in the U.S. This time one fell on the FDA’s Vaccines and Related Biological Products Advisory Committee, as one of Health and Human Services Secretary Robert Kennedy’s most outspoken critics was removed from the panel nearly a year and a half before his term was to expire.
Oddsmakers placing their bets on which drugs will be in play for round 3 of the U.S. Inflation Reduction Act (IRA) price negotiations are doing some reshuffling, thanks to an orphan drug provision tucked into the Trump administration’s One Big Beautiful Bill Act (OBBBA) that was signed into law on the Fourth of July.
Argo Biopharmaceutical Co. Ltd. and its RNAi work drew Novartis AG back to the table for a third time, as the companies entered a potential $5.2 billion deal involving cardiovascular-focused assets, including a right to first negotiation for BW-00112, an angiopoietin-like protein 3-targeting siRNA in phase II testing in severe hypertriglyceridemia.
Enlaza Therapeutics Inc. will take charge of research through nominating candidates in its potentially $2 billion-plus deal with Vertex Pharmaceuticals Inc. For its efforts, Enlaza is getting $45 million in an up-front payment and equity investment, plus the opportunity to bring in more than $2 billion in research, development, regulatory and commercial milestones and tiered royalties on net sales.
Enlaza Therapeutics Inc. will take charge of research through nominating candidates in its potentially $2 billion-plus deal with Vertex Pharmaceuticals Inc. For its efforts, Enlaza is getting $45 million in an up-front payment and equity investment, plus the opportunity to bring in more than $2 billion in research, development, regulatory and commercial milestones and tiered royalties on net sales.
Cyted Health Ltd. raised $44 million in a series B financing round to expand the reach of Endosign, its capsule sponge technology, in the U.S. Endosign is a minimally invasive device used to collect cell samples from the esophagus for the early detection of esophageal diseases, offering the potential to transform early cancer detection and improve health outcomes.
Telix Pharmaceuticals Ltd. received an FDA complete response letter (CRL) a day after the Aug. 27 PDUFA date for its BLA for radiopharmaceutical renal cancer imaging agent, Zircaix (TLX250-CDx, 89Zr-DFO-girentuximab).
The recombinant fusion protein drug telitacicept from Remegen Co. Ltd. and Vor Bio Inc. has notched a phase III win in treating adults with IgA nephropathy. The clinical trial of the fusion protein hit the primary endpoint, reducing proteinuria, too much protein in patients’ urine, in stage A of the study in China.