The U.S. FDA has approved the priority BLA for Sanofi SA’s hemophilia A treatment nearly a week before its Feb. 28 PDUFA date. The approval is for efanesoctocog alfa, a recombinant factor VIII (rFVIII) therapy – the company has managed to partially incorporate rFVIII into the drug’s brand name, Altuviiio. The price per dose was not released by the company.
Medasense Biometrics Ltd. received U.S. FDA marketing authorization for its PMD-200 patient monitor with nociception level index (NOL) technology that monitors patients’ physiological response to pain during surgery. NOL uses a multi-parametric sensor platform combined with artificial intelligence (AI) algorithms to generate a ‘signature of pain’ for patients under anesthesia who are also receiving opioids and other analgesics.
Despite pleas from patient advocacy groups and bipartisan pressure from the U.S. Congress, the Centers for Medicare & Medicaid Services (CMS) isn’t budging on its national coverage determination for amyloid-targeting monoclonal antibodies approved to treat Alzheimer’s.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Innovation Zed, Medasense Biometrics, Mologic, Remidio.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adial, Alimera, Cognition, Erydel, Fapon, GSK, Pfizer, PTC, Sage, Seagen, Viiv, Vir.
GE Healthcare Technologies Inc. reported a recall of several systems in its nuclear medicine line of high-end imaging systems for two potential issues that could lead to the collapse of a detector weighing more than half a ton onto the patient. According to the U.S. FDA listing for the recall, no injuries or fatalities have been reported in connection with these issues, but the announcement resurrects an episode from 2013 in which a patient in New York lost his life when a nuclear imaging camera collapsed during an imaging procedure.
Alivecor Inc. has nudged the U.S. International Trade Commission (ITC) into issuing a limited exclusion order for products by Apple Inc. that are said to violate patents held by Alivecor, but there is one more stage gate to go for Alivecor. The ITC order notes that the exclusion won’t go into force until resolution of an inter partes review (IPR) involving the two firms, a process that could devour as much as a year and a half before a resolution is available.
Looking to turn around the decline of clinical trials within its borders, the U.K. government appointed James O’Shaughnessy, a former health minister, board member of Health Data Research UK and a senior partner at Newmarket Strategy, to conduct an independent review of the country’s commercial clinical trial landscape.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Rapidai, Spectrum Solutions.
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