Structure Therapeutics Inc.’s stock climbed 34.6% following a readout of what analysts call “competitive” and “exceptional” phase Ib data at 28 days of oral small-molecule glucagon-like peptide 1 (GLP-1) receptor agonist GSBR-1290 in healthy overweight or obese individuals. Shares (NASDAQ:GPCR) rose $12.95 to close Sept. 29 at $50.42. At the same time as the data readout, the San Francisco-based company agreed to a $300 million private placement with several large health care institutional and mutual fund investors, extending Structure’s runway through the end of 2026. Read More
After a nearly year-long delay pegged to COVID-19 travel restrictions, the U.S. FDA has approved Amicus Therapeutics Inc.’s Pompe disease drug, introducing competition for Sanofi SA’s standard-of-care treatment and anticipating blockbuster sales. The combination of Pombiliti (cipaglucosidase alfa-atga) and Opfolda (miglustat) 65-mg capsules was approved for adults with late-onset Pompe disease, who weigh at least 40 kg and who are not improving on their current enzyme replacement therapy. Read More
National support for the biosimilar sector and the domestic industry’s efforts to increase production and sales may not be enough for South Korean biosimilar firms to box out competition in the ever-changing regulatory court of the U.S. “Competition in U.S. negotiations and rebates are fierce,” Choi Sung-ho, chairman of the Korean Society for Bioeconomy, said. “Even if you get listed, it is crucial to be placed in an advantageous class to lower out-of-pocket costs. Read More
January-August 2023 saw clinical trial data up 1.22% compared to the same time period last year. In the first eight months of this year, BioWorld reported on 2,314 drugs in phase I-III, compared to 2,286 in the same timeframe in 2022. The number of trial updates is down 13.24% from the 2,667 in 2021 and down from 2020’s 2,363, but up 20.46% from 2019’s 1,921. Read More
The Advanced Research Projects Agency for Health (ARPA-H) reported the opening of a series of regional offices that focus on both administrative and research assignments, a development that may bolster cures and treatments for tough-to-treat conditions. However, the U.S. House and Senate have different ideas about how much money the agency will receive in 2024, casting a cloud of uncertainty over how many projects the agency will be able to finance in the twelve months that will start on Oct. 1, 2023. Read More
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Clinical updates, including trial initiations, enrollment status and data readouts and publications: Actinium, Alligator, Ascletis, Biolinerx, Bionomics, Cantargia, Crystal, Edesa, Elicio, Harpoon, Immunogenesis, Imunon, J&J, Mabwell, Sagimet, Synthekine. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: AI, Akeso, Better, Modex, Orphai, PTC, Remegen, Renovaro, Thymmune. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akebia, Akeso, Alpha Cognition, Antibe, Baudax, Biomea, Bolt, Brainstorm, Calliditas, Everest, Fabre-Kramer, Karuna, Merck & Co., Oncopeptides, Stada, Takeda. Read More
