Rather than appeal an April decision by the U.S. Court of Appeals for the District of Columbia Circuit, the FDA is changing how it regulates imaging agents. That means the agency will transition at least some approved imaging agents from drug status to device status and, going forward, it will regulate products that meet both the device and drug definition as devices – unless Congress specifies otherwise.
Shares of Axsome Therapeutics Inc. (NASDAQ:AXSM) hit a 52-week low on Aug. 9, falling 46.5% to close at $24.37, after the FDA said deficiencies in an NDA in major depressive disorder for its drug, AXS-05 (dextromethorphan + bupropion), would "preclude labeling discussions" for now.
Zoll Medical Corp. has released its Remedē EL-X system for the treatment of central sleep apnea in adults, following the receipt of FDA approval. The next-generation implantable neurostimulation device will be rolled out in a phased launch in implanting centers in the U.S.
The FDA’s quarterly report on device user fee performance goals encodes a number of metrics, such as the rate at which PMA originals are cited for a major deficiency on the first review cycle. For premarket approval applications (PMAs) filed in fiscal year 2021 to date, the major deficiency rate on the first cycle is 86%, which would be tied for the fifth highest rate in two decades if that rate holds throughout the balance of the fiscal year.
Abbott Laboratories has secured FDA clearance for its latest optical coherence tomography (OCT) imaging platform powered by the company’s new Ultreon software. The artificial intelligence (AI)-powered imaging software allows doctors to view coronary blood flow and blockages more clearly, aiding in care management and treatment decisions.
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.
The FDA’s May 2021 draft guidance for post-approval studies for PMA devices did not present any regulatory novelties, but did propose tighter timelines for filing, reviewing and fulfilling post-approval study (PAS) protocols. However, a review of the agency’s PAS database suggests that both the agency and industry might have a difficult time complying with the proposed new standards for turnaround times for these studies.
After a long and tortuous development Astrazeneca plc’s anifrolumab has been approved by the FDA for the autoimmune disease systemic lupus erythematosus (SLE), setting up a rivalry with its U.K.-based counterpart Glaxosmithkline plc. The first-in-class type 1 interferon receptor antibody, the first new drug for the disease in a decade, will be marketed under the brand name Saphnelo for adults with moderate to severe disease who are receiving standard therapy.
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