Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amylyx, Arcutis, ARS, GC, Janssen.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agomab, Biomea Fusion, Cel-Sci, Calliditas, Coherus Biosciences, Innate.
Easymotionskin Tec AG is seeking patent protection for a wearable product that delivers transcutaneous electromyostimulation (EMS) of pelvic floor musculature through the body’s perineum, for the non-invasive treatment of incontinence, particularly stress incontinence. The invention is said to be suited to nearly all patients, including those patients who cannot insert anal or vaginal probes that provide pelvic floor training by EMS.
The U.S. Court of Appeals for the Federal Circuit has once again ruled on a patent dispute between Masimo Corp., of Irvine, Calif., and a rival firm, this time with Sotera Wireless Inc., of San Diego serving as the adversary. The Federal Circuit sided with Sotera in decreeing that 17 claims in Masimo’s RE47,218 (the ’218 patent) are invalidated due to the existence of prior art that rendered the claims obvious, but the irony in this litigation is that one of the patents cited by Sotera as prior art, the 6,597,933 patent, was authored in part by Joe Kiani, the founder, CEO and board chairman of Masimo.
The US FDA is offering sponsors of certain drugs and biologics more agency access as part of a pilot program that will be launching in January 2024 with the mission of accelerating the development of new therapies for rare diseases.
Biopharma companies and industry advocates received the message the U.S. FTC intended to send when it broke new antitrust ground earlier this year in challenging Amgen Inc.’s $27.8 billion acquisition of Horizon Therapeutics plc. Now they’re uniting to send a message of their own – in the guise of an awareness campaign showing that the FTC’s new approach to M&A reviews and antitrust enforcement will undermine the ecosystem responsible for innovative and important therapies the world over.
The dark cloud of what the U.S. FDA called potential “systemic bias” rained on Amgen Inc.’s bid for full approval of Lumakras (sotorasib), a KRAS-G12C inhibitor that was granted accelerated approval in May 2021 for locally advanced or metastatic non-small-cell lung cancer after at least one systemic therapy.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Lipgems International, Precision Neuroscience.
Connex Biomedical Inc. applied for patent protection for a transcardiac access port affixed and retained post-procedure on the cardiac muscle, such as the ventricular myocardium, and an access port delivery system configured to deliver the access port, secure the access port to the muscle tissue with tissue anchors, and provide a working channel through the access port to facilitate transcardiac access and device delivery.
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