The reach of the med-tech patent wars now includes devices for electroencephalography thanks to a complaint recently filed by Sunnyvale, Calif.-based Ceribell Inc. with the U.S. International Trade Commission. The company alleged infringement of six of its patents by two units under the Natus umbrella of companies, but this conflict is also under review in Delaware district court, promising a drawn-out conflict that may not resolve for years.
Doing his version of the Texas Two-Step, Texas Attorney General (AG) Ken Paxton is again shuffling Eli Lilly and Co. into a state courtroom – this time for allegedly overstepping the anti-kickback line.
The increasing recognition of its importance in national security, economic growth and health has seen biotech emerging as the latest frontier in geopolitical competition, with implications for companies ranging from startups to multinationals – and for global investment in the sector.
Quantumpharm Inc., known as Xtalpi Inc., announced receiving $51 million up front from a potential $5.99 billion deal with Dovetree LLC on Aug. 6. The collaboration, first inked through a letter of intent between the two parties on June 23, will combine Shenzhen, China-based Xtalpi’s AI-based and robotics-driven discovery platform with Dovetree’s “biological insights.” The goal will be to select and validate potential first-in-class candidates for Dovetree across five areas of oncology, immunology and inflammatory diseases, neurological disorders and metabolic dysregulation.
Syntara Ltd.’s stock plummeted 52% on news that the FDA recommended an additional phase IIb trial following a type C meeting about the company’s clinical development plan for lysyl oxidase inhibitor amsulostat (SNT-5505, formerly PXS-5505) in myelofibrosis.
Novartis AG’s monoclonal antibody, ianalumab, has notched back-to-back wins, one in treating Sjögren’s disease and the other for primary immune thrombocytopenia (ITP). In Sjögren’s, which has no U.S. FDA-approved treatment, the phase III Neptunus-1 and Neptunus-2 studies are the first phase III trials to prompt statically significant reductions in adults with the autoimmune disease. In ITP, a disease that has yet to see a cure, top-line data of a phase III study of ianalumab combined with eltrombopag stretched to the time to treatment failure compared to placebo, the primary endpoint showing the maintenance of safe platelet levels.
With a packed pipeline of drug candidates targeting multiple markers of cancer, Bayer AG signed on for a new project, this time going after the KRAS pathway with a global deal that could bring Kumquat Biosciences Inc. up to $1.3 billion in payments.
In less than two weeks, Setpoint Medical Inc. mastered the power serve with the first approval of a neuroimmune modulation device to manage rheumatoid arthritis, followed by a $25 million second tranche of its series C and a $115 million series D financing round.
Eleven pages is relatively short for a modern U.S. FDA draft guidance, but two trade associations nonetheless had questions about the FDA draft for transfers of 510(k) devices, such as how the agency defines the holder of the 510(k).
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