In December 2024 BioWorld recorded 212 clinical trial updates, an increase from 180 in November and closely aligning with 219 in October. The month saw 16 successful phase III outcomes, along with two mixed results and two trial failures. Eli Lilly and Co. reported that its FDA-approved weight-loss drug Zepbound (tirzepatide) outperformed Novo Nordisk A/S’s Wegovy (semaglutide) in the phase IIIb Surmount-5 trial.
The U.S. FDA approved 19 drugs in December, an increase from 10 in November. In total, 228 FDA approvals were granted in 2024, averaging 19 per month. Seven new molecular entities were approved in December, bringing the year's total to 49.
Med-tech stocks experienced a turbulent year of ups and downs in 2024, as the BioWorld Med-Tech Stock Index saw lows of almost 15% and gains of nearly 5% before closing the year up 0.21%. This modest rebound follows consecutive declines of 4.44% in 2023 and a steep drop of 39.58% in 2022.
With more than five dozen generics already tentatively approved for 10 of the drugs selected for the next round of the Medicare Price Negotiation Program, the impact of the negotiations won’t be limited to just the brand drugs.
It’s one thing for the scientific community to propose a fundamental change to the way obesity is defined and diagnosed. But it’s another for that proposal to be adopted by regulators, especially when the current definition that relies primarily on the body mass index is entrenched in guidance and obesity drug development and approval.
As more Asia biotechs turn to regenerative medicine to address disorders without a cure, Medipost Inc. is continuing global expansion with Cartistem, its allogeneic human umbilical cord blood-derived mesenchymal stem cell product that gained clearance in South Korea in 2012 to treat knee osteoarthritis.
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