Johnson & Johnson received U.S. FDA investigational device exemption to begin the pivotal clinical trial for the Ottava robotic surgical system. If the trial goes well, Ottava could pose a significant challenge to decades-long dominance of the robotic surgical market by Intuitive Surgical Inc.’s Da Vinci system.
Device makers are not necessarily fond of the need to acquire Medicare coverage by picking off one Medicare administrative contractor at a time, but Cleerly Labs Inc. worked this path with gusto.
More than two years since emerging from stealth, Vesalius Therapeutics Inc. signed its first major pharma deal with GSK plc. Worth up to $650 million and possibly more if an option is exercised, the multitarget alliance aims to discover and develop novel treatments for Parkinson’s disease and another neurodegenerative indication.
Flare Therapeutics Inc. will receive $70 million in cash up front from Roche Holding AG, and the deal could ultimately bring the company about $1.8 billion plus royalties. Flare will search for small molecules that can be used to treat undruggable transcription factors to treat cancer. Also, Novartis AG will pay computational-chemistry expert Schrödinger Inc. $150 million up front and as much as $2.3 billion in milestones to develop several candidates along with up to $892 million in R&D and milestone payments.
The competitive menin-inhibitor space chalked further data from Syndax Pharmaceuticals Inc., which disclosed positive top-line results from the pivotal phase II portion of the Augment-101 study, designed to test oral small-molecule revumenib for safety and efficacy. But shares of the firm (NASDAQ:SNDX) closed Nov. 12 at $16.21, down $5.57, or 26%, after the Augment-101 numbers were disclosed.
More than two years since emerging from stealth, Vesalius Therapeutics Inc. signed its first major pharma deal with GSK plc. Worth up to $650 million and possibly more if an option is exercised, the multitarget alliance aims to discover and develop novel treatments for Parkinson’s disease and another neurodegenerative indication.
Flare Therapeutics Inc. will receive $70 million in cash up front from Roche Holding AG, and the deal could ultimately bring the company about $1.8 billion plus royalties. Flare will search for small molecules that can be used to treat undruggable transcription factors to treat cancer. Also, Novartis AG will pay computational-chemistry expert Schrödinger Inc. $150 million up front and as much as $2.3 billion in milestones to develop several candidates along with up to $892 million in R&D and milestone payments.
The FDA has lifted a clinical hold on Carsgen Therapeutics Holdings Ltd.’s. CAR T products after issuing the company a warning letter following a December 2023 FDA inspection that found the company violated good manufacturing practices at its Research Triangle Park facility in Durham, N.C.
Positive findings from a phase III trial of semaglutide in metabolic dysfunction-associated steatohepatitis (MASH) is moving Novo Nordisk A/S to expand the glucagon-like peptide-1 (GLP-1) agonist’s indications in the U.S. and Europe, the Danish pharma said, as the MASH field sights more novel therapies.
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