Introduced last year as a pilot program, the U.S. FDA Commissioner’s National Priority Voucher (CNPV) could be here to stay – at least for the duration of Marty Makary’s tenure as FDA commissioner. Since the FDA unveiled the CNPV last June, it has welcomed 18 products from 16 companies into the “game-changer” program for patients, as Makary described it. The goal is to provide an “ultrafast review pathway,” one to two months instead of the standard 10 to 12 months, for drugs and biologics of strategic national importance while maintaining the FDA’s scientific and regulatory standards, according to the agency.
Eli Lilly and Co. is deepening its investment in artificial intelligence-driven drug discovery through a multibillion-dollar expansion of its collaboration with Hong-Kong listed Insilico Medicine Inc. in a move that could broaden its reach into next-generation metabolic therapies.
A regulatory plod that began in 2023 – and met with success in many other territories – at last crossed the U.S. FDA finish line when Novo Nordisk A/S secured approval of Awiqli (insulin icodec) injection 700 units/mL, the first and only once-weekly, long-acting basal insulin.
The debated and ultimately stock-denting March 26 news from Wave Life Sciences Inc. pushed into the spotlight other firms working with INHBE and activin E.
Aconcagua Bio Inc. has divulged new calcitonin (CALCR; CT-R) and amylin receptor agonists intended for use in the treatment of pain, neurodegeneration, bone, metabolic and cardiovascular disorders.
The Shanghai Institute of Materia Medica of the Chinese Academy of Sciences has synthesized new polycyclic heteroaryl compound acting as glucagon-like peptide 1 receptor (GLP-1R) agonists potentially useful for the treatment of diabetes and obesity, among others.
A next-generation triple incretin therapy jointly developed by Novo Nordisk A/S and China’s United Biotechnology outperformed semaglutide in a phase II trial, signaling intensifying competition in the GLP-1 obesity and diabetes market.
Apparently put off by data with a higher dose, investors in Wave Life Sciences Inc. backed away after the company rolled out data from the phase I portion of its first-in-human Inlight trial evaluating 250 mg of WVE-007, an INHBE GalNAc-siRNA prospect, in otherwise healthy overweight or obese adults.
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