The annual scramble for elevated payment rates under the U.S. Medicare inpatient rule has concluded, and at least one artificial intelligence product came up short in its bid for a new technology add-on (NTAP) payment. However, Medtronic plc, Boston Scientific Corp. and Cook Medical Inc. all secured or sustained NTAP payments for products that are critical for patients with a variety of life-threatening conditions, such as severe pulmonary valve regurgitation in pediatric patients.
PERTH, Australia – In a possible world-first decision, an Australian court has ruled that artificial intelligence can be named as the inventor of a patent. Federal Court Justice Jonathan Beach ruled in Thaler v. Commissioner of Patents that under Australian patent law, inventors don’t necessarily have to be human.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abl, Advita, Aldeyra, Arcturus, Bausch, BMS, CSL, Cytodyn, Marinus, Medexus, Moderna, Monopar, Novartis, Panther, Pharmather, Relief, Roche, UCB.
Ushering in a new era for the U.S. biosimilar marketplace, the FDA, on July 28, approved its first interchangeable biosimilar, which also will be the first to bring biosimilar competition to the U.S. insulin space. The honor went to Viatris Inc.’s Semglee, which the FDA recognized as both biosimilar to and interchangeable with Sanofi SA’s Lantus (insulin glargine).
Keystone Heart Ltd. had the unusual experience of being the sponsor of a rare class II device appearance before an FDA advisory committee, which considered whether the company’s Triguard 3 device was substantially equivalent (SE) to a predicate device. However, the company’s bid for an SE result was unsuccessful, likely leaving Keystone with a considerable additional regulatory lift before the company can get to market.
Despite prior marketing approvals in Europe and Canada, an effort to win FDA support for the bifunctional alkylating agent treosulfan has drawn a complete response letter (CRL) from the agency, the company's U.S. rights holder, Medexus Pharmaceuticals Inc., said.
Statements Cytodyn Inc. made about the potential for its investigational monoclonal antibody, leronlimab, to treat COVID-19 continue to reverberate with U.S. authorities.
Rapid changes, a traditionally conservative approach and a chronic lack of regulatory transparency could undo a lot of the progress that Japan has made in the past few years to speed up approvals and all but eliminate a punishing drug lag that, for decades, held back the development of the country’s biopharma sector.
China’s National Health Commission has just released a new set of regulations to evaluate the clinical value of both approved drugs and those still in trials as part of its efforts to improve the market standards.
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