Aureka Biotechnologies closed a $100 million Series B to expand biological foundation models, closed-loop automated experimentation and antibody-drug discovery. Granite Asia funded the first tranche; an unnamed strategic investor led a later tranche, with…
FDA issued a Complete Response Letter for ITM’s 177Lu-edotreotide NDA in gastroenteropancreatic neuroendocrine tumors. ITM said the letter cited chemistry, manufacturing and controls and third-party commercial-facility inspection items, without identifying clinical, nonclinical, or safety…
Sionna Therapeutics reported that adding the NBD1 stabilizer SION-719 to Trikafta for 14 days did not achieve the Phase IIa trial’s key activity endpoint. Mean placebo-adjusted sweat chloride change was −1.0 mmol/L with p=0.7….
A peer-reviewed Nature Medicine study from the University of Pennsylvania characterized 4-1BB-costimulated CD19 CAR T cells up to 10.1 years after infusion in 38 patients with B-cell non-Hodgkin lymphoma. Beyond year five, the CAR…
Innovent Biologics and Daiichi Sankyo entered an exclusive agreement for commercialization of VANFLYTA (quizartinib) in China. Innovent will hold sole commercialization rights and lead market promotion, while Daiichi Sankyo retains development, manufacturing and supply…
China’s NMPA accepted Alebund Pharmaceuticals’ new drug application for AP301, a non-absorbed fiber-iron phosphate binder for hyperphosphatemia in maintenance-dialysis patients with chronic kidney disease. The filing is supported primarily by the 474-patient, 52-week RESPOND-1…
Scholar Rock will remove Catalent Indiana from the apitegromab biologics license application after FDA classified the site’s April inspection as Official Action Indicated. FDA review is proceeding with a second U.S. fill-finish facility, and…
The FDA approved Takeda’s Orzeyful (oveporexton), an oral orexin receptor 2 (OX2R)-selective agonist, for narcolepsy type 1 in adults. Takeda and multiple independent outlets describe it as the first medicine approved to address the…
A peer-reviewed Blood study combined single-cell multiome profiling with a three-dimensional, N-cadherin-supported culture system, pharmacologic YTHDF2 inhibition and the self-renewal agonist UM729 to expand serially transplantable human long-term hematopoietic stem cells (LT-HSCs) with balanced…
