Therabionic GmbH received U.S. FDA humanitarian device exemption (HDE) for its P1 device for at-home treatment of hepatocellular carcinoma, which accounts for 80% of all liver cancers, in patients who have failed first- and second-line therapies.
Researchers from the University of Michigan have filed for patent protection of methods and systems to identify actual esophageal tissue changes and/or damage during cardiac ablation procedures.
With the U.S. FDA giving the green light to Takeda Pharmaceutical Co. Ltd.’s Adzynma for treating a rare blood clotting disorder caused by a deficiency in the ADAMTS13 enzyme, the company has won two approvals in two days after the FDA approved fruquintinib a day earlier.
With Valneva SE’s accelerated approval from the U.S. FDA for chikungunya vaccine Ixchiq, attention turned to the February 2024 meeting of the Advisory Committee on Immunization Practices (ACIP), which will vote on the product. A single-dose, live-attenuated vaccine, Ixchiq is designed to prevent disease caused by the virus in people 18 and older who are at increased risk of exposure to the bug.
The America Invents Act of 2011 was designed to provide a durable overhaul of the U.S. patent system, but the inter partes review (IPR) process has drawn fire from inventors as a patent-killing machine. The Senate is considering a new bill to address some of these concerns, but witnesses at a hearing this week were anything but united in their assessment of the status quo, making it difficult to forecast the fate of this latest effort at patent reform.
Emboline Inc. is seeking patent protection for methods and apparatus for embolic protection during cardiac procedures being performed on atrial outlet valves, namely, the mitral and tricuspid valves.
A number of recent developments in artificial intelligence (AI) have sent some reassurance that these algorithms will not hit the market completely devoid of regulation, but a Nov. 8 hearing in the U.S. Senate makes clear that Capitol Hill is intent on legislating on AI, even if only belatedly.
Carrying through on a policy it adopted a few months ago to crack down on potentially anticompetitive FDA Orange Book listings, the U.S. FTC put 10 drug companies on notice that it’s challenging several of their “improperly or inaccurately listed” patents through the FDA’s regulatory dispute process.
A year-and-a-half after Eli Lilly and Co.’s Mounjaro (tirzepatide) gained U.S. FDA approval for adults with type 2 diabetes, the GLP-1 and GIP dual agonist was cleared for chronic weight management in adults who are obese or overweight and who also have one related condition.
Johnson & Johnson expects to submit the long-awaited Ottava robotic surgical system to the U.S. FDA for an investigational device exemption (IDE) in the second half of 2024, nearly three years later than the company anticipated when its Ethicon Inc. unit acquired Ottava along with Auris Health Inc. in 2019.
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