The next major shock wave to hit the U.S. biopharma and med-tech industries could be the fiscal 2026 federal budget. Nearly one-third of the discretionary budget for the Department of Health and Human Services (HHS) could be wiped out, according to the White House Office of Management and Budget’s “pre-decisional” budget proposal, or passback, for HHS.
Days after Pfizer Inc. pulled the plug on its oral GLP-1 candidate danuglipron, Eli Lilly and Co. aired positive top-line data from the phase III trial called Achieve-1 testing orforglipron vs. placebo in adults with type 2 diabetes and inadequate glycemic control with diet and exercise alone.
Glycomine Inc. secured $115 million in a series C financing round to support the advancement of GLM-101 into a phase IIb study in patients with phosphomannomutase-2 congenital disorder of glycosylation (PMM2-CDG).
China’s National Medical Products Administration (NMPA) has accepted Innocare Pharma Ltd.’s NDA for its second-generation pan-tropomyosin receptor kinase inhibitor, zurletrectinib (ICP-723), for treating adults and adolescents with advanced solid tumors harboring neurotrophic tyrosine receptor kinase gene fusions.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accent, Atsena, Celltrion, Immunitybio, Lyell Immunopharma, Precision, Scilex, Valneva.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biocon, Boehringer, Catalent, Cellino, Cue Biopharma, Daiichi Sankyo, Invo Fertility, Karis, Lisata, Mural Oncology, Naya, Norgine, Oak Hill, Roche, Regeneron, Rege Nephro, Statera, Syros, Theravia, Tivic Health Systems, Wayfinder.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: BMS, Entera, Eyestem, Faron, Hoth, Metavia, Plus, Sanofi, Toragen.
After more than three years of discussion, the World Health Organization’s Intergovernmental Negotiating Body (INB) has agreed on a proposal to prevent, prepare and respond to a pandemic. The plan is born, the INB proposal said, out of inequities around the world that slowed timely and equitable access to health products to respond to the COVID-19 pandemic.
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