Device recalls may seem an ordinary fact of life, given that some are declared for reasons as innocuous as a change of labeling, but the five device recalls announced by the U.S. FDA April 24 and 25 include one product withdrawal. The recall for the Nimbus series of infusion pumps and administration sets by Infutronix LLC cited instances in which patients were subjected to out-of-specification analgesia flow rates, and the company has seen fit to remove the existing inventory from the market.
Front Line Medical Technologies Inc. recently received CE mark for its Cobra-OS, the smallest REBOA (resuscitative endovascular balloon occlusion of the aorta) device for use in emergency situations on the market. The company believes that Cobra-OS could help save the lives of patients during traumatic bleeding situations as it could buy valuable time until definitive care can be provided.
Pfizer Inc.’s Beqvez (fidanacogene elaparvovec) won FDA approval for use in adults with hemophilia B, making it the second adeno-associated viral (AAV) vector-based gene therapy available for patients in the U.S., following the late 2022 approval of CSL Behring’s Hemgenix (etranacogene dezaparvovec).
The U.S. FDA issued a revised draft guidance, “Promotional labeling and advertising considerations for prescription biological reference and biosimilar products,” to help ensure promotional communications involving reference biologics or their follow-ons are accurate, truthful and not misleading.
The U.S. FDA’s device center launched a new health care program designed to provide patients with a seamless home health care environment that stitches together various health care functions into an integrated system that eases the patient’s use of such technologies. The initiative, part of the agency’s health equity agenda, will rely on augmented and virtual reality and requires the development of a prototype that will be rolled out in underserved areas with several overarching objectives, including the democratization of clinical trial participation.
Hookipa Pharma Inc. has received clearance from the U.S. FDA for its IND application for HB-700, a novel arenaviral therapeutic vaccine for the treatment of KRAS-mutated cancers. The HB-700 program is a replicating 2-vector therapy designed to treat KRAS-mutated lung, colorectal, pancreatic and other cancers by targeting the five most prevalent KRAS mutations in these disease indications.
The U.S. FDA approved Utility Therapeutics Ltd.’s Pivya (pivmecillinam), an oral prodrug of injectable mecillinam, on its April 24 PDUFA date for female adults with uncomplicated urinary tract infections (UTIs) caused by Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus.
The EU has declared that it will investigate the anticompetitive practices of the People’s Republic of China where medical devices are concerned, a clear sign that device makers in the European Union succeeded in persuading Brussels that the Made in China 2025 initiative represents an intolerable form of economic adversarialism.
South Korean med-tech companies Nunaps Co. Ltd. and Share & Service are the latest to clear domestic approvals for digital therapeutics as the government ramps up R&D funding for artificial intelligence-based medical technologies.
The U.S. Federal Trade Commission’s final rule for noncompete clauses in employment contracts would seem to endanger life science patents and trade secrets, but there is a question of whether the agency stepped outside its statutory bounds in forming the rule. The U.S. Chamber of Commerce has already filed suit on the rule, but Joshua Rich of McDonnell Boehnen Hulbert & Berghoff LLP told BioWorld, that the Chamber is unlikely to be the last entity to file suit over the rule.
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