Following the death of a patient, the U.S. FDA halted Arcellx Inc.’s phase II pivotal trial of its CAR T-cell therapy for relapsed or refractory multiple myeloma (MM), putting Gilead Sciences Inc., which in December made the risky decision to part with $225 million up front for rights to the immunotherapy, in likely turmoil.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: F2G, Freya, Iaso, Sirnaomics, SK.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cardio Flow Design, Owlet, Surmodics, Zynex.
The U.S. Federal Trade Commission (FTC) reported a settlement with San Francisco-based 1Health.io Inc. for allegations that the consumer gene testing company failed to properly secure customers’ data, an oversight that will cost the company only $75,000 in fines.
Radiotherapy fractionation has had a significant impact on the morbidity associated with the procedure across a number of cancer types, and the U.K. National Institute for Health and Care Excellence (NICE) says it may be time to fractionate further for some breast cancer patients.
What could be the first newly approved antifungal in nearly 20 years based on a novel mechanism hit a bump as F2G Ltd. has received a complete response letter from the U.S. FDA.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BMS, Genentech, GSK, Nanjing Leads Biolabs, Reata, Roche, TG Immunopharma, TME.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avita Medical.
The Vanta device by Medtronic plc, provides relief from pain for thousands of patients, but the Vanta might also feel the pain when the patient is undergoing cardioversion. According to a field safety notice from Dublin-based Medtronic, two patients in Europe have undergone explant procedures for the device due to damage sustained during cardioversion, but the company urges physicians to pay heed to the labeled indication, which recommends that the device be temporarily reprogrammed to reduce the risk of damage to the device, an action that Medtronic indicated should ward off any such issues.
Artificial intelligence (AI) faces a number of interesting hurdles in the EU, such as the still-developing Artificial Intelligence Act (AI Act), which seems destined to treat health care uses as high-risk propositions. Corinne Dive-Reclus, director of global lab insights at Roche Diagnostics, said there are possible solutions, such as overwriting the AI Act’s risk classifications with the risk category provided by existing regulations, but there is an open question as to whether a fix will be in place to prevent a potentially disastrous risk framework for AI in health care.
RSS
