Third-party testing of medical devices is an established practice, but some testing labs are more reliable than others. The U.S. FDA has warned device manufacturers that some of these labs are turning out falsified data in connection with such testing, calling out labs located in China and India as unusually suspect sources of testing data.
After more than a decade of industry pleading for guidance on Orange Book patent listings, the U.S. FDA is finally planning on answering that request this year. If the guidance that’s produced reflects the FTC’s position that device patents can’t be listed for combination products, it could overturn years of accepted practice and possibly hinder the development of new, more advanced drug administration technologies.
Less than a month after the U.S. FDA approved Sanofi SA and Regeneron Pharmaceuticals Inc.’s bestseller Dupixent (dupilumab) for treating eosinophilic esophagitis in children ages 1 to 11, the agency has approved Takeda Pharmaceutical Co. Ltd.’s Eohilia (budesonide oral suspension) for the same indication but for an older group.
Citing national security and intellectual property (IP) concerns, a bipartisan group of U.S. lawmakers is calling on three federal departments to investigate China’s Wuxi Apptec’s ties, and that of its subsidiary, Wuxi Biologics, to the Chinese Communist Party and the country’s People’s Liberation Army.
Roughly 35 years after early patient data suggested the potential of tumor-infiltrating lymphocytes (TIL) in cancer, Iovance Biotherapeutics Inc. received U.S. FDA approval for lifileucel, marking both the first autologous TIL cell therapy for commercial use and the first one-time cell therapy for a solid tumor cancer. Branded Amtagvi, lifileucel is cleared for use in patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation-positive, a BRAF inhibitor with or without a MEK inhibitor
The U.S. FDA’s device center has been prodding industry for some time to develop a culture of quality regarding the manufacture of medical devices, an emphasis that has resulted in the development of several programs. While the recent harmonization of the FDA’s device quality system regulation with an international standard might seem oblique to this culture of quality consideration, the FDA’s Keisha Thomas advised industry that the overhaul of the Quality System Regulation (QSR) is seen inside the agency as part and parcel of that quality push, a statement that seems to suggest that the FDA’s expectations regarding device manufacturing will be more stringent going forward.
Better Therapeutics Inc.’s prescription digital therapeutic (PDT) received U.S. FDA breakthrough device designation for metabolic dysfunction-associated steatohepatitis (MASH), an advanced form of fatty liver disease that increases the risk of cirrhosis, liver failure and liver cancer but has few good treatments available.
X-trodes Ltd. has received U.S. FDA 510(k) clearance for its Smart Skin solution, a wireless wearable technology that allows for medical-grade electrophysiological monitoring in clinics and at home. The company believes that the Smart Skin technology, which captures signals from the brain, heart, eyes and muscles, has the potential to significantly improve patient care.
The U.S. Department of Justice (DOJ) announced in May 2023 that it had obtained a judgment of more than $487 million against the parent company of Precision Lens for alleged violations of the False Claims Act (FCA), but the amount of that decision has been overturned. In a Feb. 8 decision, the U.S. District Court for the District of Minnesota decreed that the judgment be reduced to less than $217 million, an outcome which suggests that some of the more excessive fines levied against health care companies will be viewed with more skepticism upon appeal.
The U.S. FDA reported Feb. 15 that Philips USA, a subsidiary of Amsterdam-based Royal Philips NV, recalled three models of the Brightview line of single photon emission CT (SPECT) systems due to an incident in which the system detector fell.
RSS
