The U.S. FDA has posted the long-awaited final rule for lab-developed tests, which amends the draft rule in a few key respects, but Reps. Diana DeGette and Larry Buchson, once again voiced their opposition to the rule. DeGette and Bucshon acknowledged that congressional inaction has left the FDA with few choices, but called again for passage of the Verifying Accurate, Leading-edge IVCT Development (VALID) Act, which they said is critical because “burdensome regulation of these medical products creates uncertainty in the future of innovation and patient care.”
X4 Pharmaceuticals Inc. is raring to go with marketing after the firm scored U.S. FDA approval of Xolremdi (mavorixafor) capsules for patients 12 years and older with warts, hypogammaglobulinemia, infections and myelokathexis, or WHIM syndrome, to increase the number of circulating mature neutrophils and lymphocytes.
The FDA has cleared Prime Medicine Inc.’s IND application for PM-359 for the treatment of chronic granulomatous disease (CGD), enabling initiation of a phase I/II trial in the U.S.
The government of Colombia, after signaling its intent to do so at the end of 2023, issued a compulsory license on April 24 for access to generic versions of HIV drug dolutegravir, without the permission of patent owner Viiv Healthcare Ltd.
Amidst a slew of end-of-week, positive EMA Committee for Medicinal Products for Human Use (CHMP) opinions is Takeda Pharmaceutical Co. Ltd.’s Fruzaqla (fruquintinib). The selective inhibitor of vascular endothelial growth factor receptors-1, -2 and -3 is for adults with previously treated metastatic colorectal cancer.
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.
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