A U.S. FDA advisory panel voted unanimously against approving Johnson & Johnson’s V-Wave Ventura shunt for heart failure patients not helped by medications. The circulatory panel voted emphatically 15-0 against use of the shunt for heart failure patients not helped by medications based on effectiveness and its benefit-risk profile. On the question of safety, the panelists did vote 9-6 in favor of the device.
Contineum Therapeutics Inc.’s midstage study of its multiple sclerosis drug, PIPE-307, missed its primary and secondary endpoints, dropping the stock on Nov. 21. Top-line phase II results from the Vista study of the M1 receptor agonist PIPE-307 for treating relapsing-remitting multiple sclerosis saw no significant changes in binocular 2.5% low contrast letter acuity in the treatment arms, a key efficacy measure.
About a month after rolling out positive phase I/II data with its candidate for metastatic, castrate-resistant prostate cancer (mCRPC), Halda Therapeutics Inc. disclosed the plan by Johnson & Johnson (J&J), which is paying to take over the company for $3.05 billion in cash.
Breaking up isn’t so hard to do, it seems. Just two years after spinning off its consumer products as Kenvue Inc., Johnson & Johnson aims to part ways with its orthopedics unit, which will take up the Depuy Synthes name first created when Synthes Inc. married into the J&J Depuy ortho unit in 2012 for a tidy sum of $19.7 billion. Depuy was itself acquired in 1998.
Breaking up isn’t so hard to do, after all. Just two years after spinning off its consumer products as Kenvue Inc., Johnson & Johnson aims to part ways with its orthopedics unit, which will take with it the Depuy Synthes name first created when Synthes Inc. married into the J&J Depuy ortho unit in 2012 for a tidy sum of $19.7 billion. Depuy was itself acquired in 1998.
Johnson & Johnson Medtech won out over a jury verdict that found the company’s Depuy Synthes liable for $20 million for infringing a patent claimed by Rasmussen Instruments LLC.
Pharma companies are collaborating to boost the power of artificial intelligence (AI) in drug discovery by allowing access to proprietary structural data to train a large language model. Each of the partners is contributing data from several thousand experimentally determined protein:ligand interactions, creating one of the most diverse datasets and the richest chemistry assembled to date for model training.
Pharma companies are collaborating to boost the power of artificial intelligence (AI) in drug discovery by allowing access to proprietary structural data to train a large language model.
The debate around the U.S. 340B prescription drug discount program is once again heating up in court and in Congress. A day after the American Hospital Association called on the FTC and Department of Justice to investigate alleged antitrust issues with the rebate models a few drug companies have proposed, some members of Congress raised concerns Sept. 9 about how providers are abusing the program. Meanwhile, a U.S. appellate court heard arguments that same day on whether states can speak in the silence of the federal law that created the program more than 30 years ago.
Less than two months after receiving priority review status for an NDA, Johnson & Johnson won U.S. FDA approval of Inlexzo, its intravesical gemcitabine-releasing system previously known as TAR-200, to treat adults with Bacillus Calmette-Guérin-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ, with or without papillary tumors.
