Focused on oral therapies for obesity, diabetes and rare diseases, Boston-based Syntis Bio Inc., which raised $15.5 million through seed funding last year, emerged from stealth to advance its synthetic tissue-lining technology and a pipeline of candidates.
The U.S. FDA clamped a full clinical hold Biomea Fusion Inc.‘s phase I/II study of BMF-219 for treating type 1 diabetes and type 2 diabetes. The hold sank the stock on June 7 as the company looked to find answers so it could sit down with the agency to discuss next steps.
Novo Nordisk A/S’s once-weekly human insulin analogue for adults with type 1 diabetes mellitus could be a useful tool for patients and physicians, the U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee said May 24, but it also agreed that the risks outweighed the benefits for improving glycemic control.
Once-daily insulin treatment is getting a challenge from Novo Nordisk A/S’s once-weekly option. The U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee meets Friday, May 23, to review the BLA for once-weekly Awiqli (insulin icodec), a human insulin analogue from Novo for adults with type 1 diabetes mellitus.
As a meeting looms of the U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee to evaluate a similar product from Novo Nordisk A/S, Eli Lilly and Co. made public positive top-line phase III data with its once-weekly insulin, efsitora alfa, in adults with type 2 diabetes using insulin for the first time and in those who require multiple daily injections.
Innovent Biologics Inc.’s glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor dual agonist, mazdutide, met the primary endpoint of superiority in a head-to-head phase III trial in Chinese patients with type 2 diabetes compared to Eli Lilly and Co.’s GLP-1, dulaglutide, for glycemic control.
Homerun success of Novo Nordisk A/S’ semaglutide, which recently became the U.S.’s biggest blockbuster drug, is serving as an “inflection point” for obesity therapeutics and fueling the drive for new and improved therapies, speakers said at Bio Korea 2024 on May 8.
In the wake of Novo Nordisk’s semaglutide nabbing the title of the U.S.’s biggest blockbuster drug, it’s little surprise that Amgen Inc.’s obesity candidate, Maritide (maridebart cafraglutide), hogged the stage during the firm’s first-quarter earnings call after market close May 2, with company executives touting promising phase II data and a differentiated profile, sending shares of Thousand Oaks, Calif.-based Amgen (NASDAQ:AMGN) up nearly 12% to close May 3 at $311.29.
South Korea’s HK Inno.N Corp. said on May 2 that it gained exclusive development and commercial rights to Hangzhou, China-based Sciwind Biosciences Co. Ltd.’s once-weekly, injectable glucagon-like peptide-1 (GLP-1) agonist, XW-003 (ecnoglutide), in South Korea to treat type 2 diabetes and obesity.
Follow-on biologic makers in China have been working to capitalize on looming patent cliffs of blockbuster biologics. Advancing biosimilars of denosumab (Prolia/Xgeva; Amgen Inc.) and semaglutide are the latest examples.
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