Merck & Co. Inc. has turned to Asia for a second time to get into the GLP-1 market, this time to Shanghai-based Hansoh Pharmaceutical Group Co. Ltd. for its investigational preclinical oral small-molecule GLP-1 receptor agonist. Hansoh is getting $112 million up front and could bring in another $1.9 billion in milestone payments. Merck said the addition to its GLP-1 arsenal is “to provide additional cardiometabolic benefits beyond weight reduction.”
Wall Street must wait until 2025 for data from the higher-dose cohort in Tenaya Therapeutics Inc.’s phase Ib/II study with gene therapy TN-201 for MYBPC3-linked hypertrophic cardiomyopathy (HCM), but shares (NASDAQ:TNYA) closed Dec. 17 at $1.41, down $1.47, or 51%, after results from the first cohort rolled out.
After Keros Therapeutics Inc.’s voluntary halt of dosing in two arms of its phase II study in pulmonary arterial hypertension, the company’s stock crumpled after a year of muscular performance and its recent and massive deal with Takeda Pharmaceutical Co. Ltd.
China’s National Medical Products Administration (NMPA) granted new approvals to several Chinese biopharmaceuticals this week, including expanding indications of four different cancer drugs and clearing one sublingual tablet for stroke.
Novartis AG lost its bid, at least for now, to delay generic competition to its blockbuster heart drug, Entresto (sacubitril, valsartan), on the basis of patent infringement.
At the Breakthroughs in Muscular Dystrophy special meeting held in Chicago Nov. 19-20, 2024, and organized by the American Society of Gene & Cell Therapy (ASGCT), multiple interventions at the RNA level were among the approaches that were presented to fight muscular dystrophies.
Since the isolation of the gene that causes Duchenne muscular dystrophy (DMD), scientists have progressed in understanding the mechanisms that lead to muscular diseases that can be evident from the early stages of childhood. This has led to the development of diagnostics and therapeutics, some approved by the FDA.
With the U.S. FDA approval of Attruby (acoramidis) for transthyretin amyloidosis with cardiomyopathy (ATTR-CM), Bridgebio Pharma Inc. is taking on an industry giant. The next-generation, oral, small-molecule stabilizer of transthyretin will take on Pfizer Inc.’s Vyndamax (tafamidis, Vyndaqel), a TTR stabilizer approved in 2019 for ATTR-CM but expected to lose exclusivity in late 2028. The approval was based on a phase III study that showed Attruby significantly reduced death and cardiovascular-related hospitalizations. The NDA, which had a Nov. 29 PDUFA date, was approved Nov. 22.
An international consortium of thousands of scientists is creating the Human Cell Atlas, a three-dimensional map of all the cells in the body. The goal is to understand all the cells that make up human tissues, organs and systems, which will enable multiple medical applications. This collection of cell maps is openly available for navigation at single-cell resolution, identified through omics analyses that reveal the tridimensional distribution of each cell.
“It all comes down to outcomes,” said Michael Davidson, CEO of Newamsterdam Pharma Co. NV, which hailed “robust” and “consistent” data from its phase III study testing a fixed-dose combination of CETP inhibitor obicetrapib plus established anti-cholesterol drug ezetimibe, even as investors focused on a couple of findings that turned up lower than expected, sending shares of the company (NASDAQ:NAMS) down 15.5% to close Nov. 20 at $20.01.
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