Draeger Inc., of Telford, Pa., reported a recall of several lines of positive airway pressure (PAP) and other ventilation products in connection with problems seen in the adhesive used on breathing circuit components. Draeger said it has no reports of adverse events in connection with separation of the affected components during ventilation processes but has completed its testing of the corrective action and is working to replace the affected devices.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Femasys, Hemovent, Masimo, Neuspera, Rapidai, Syantra.
Sanofi SA’s antitrust challenge of Mylan Inc.’s “exclusionary conduct” in the epinephrine auto-injector market met the end of the road April 17 when the U.S. Supreme Court denied cert.
Pharma groups are calling on Japan’s Ministry of Health, Labour and Welfare (MHLW) to reconsider its current drug pricing policies that include annual price cuts on innovative drugs.
As expected, the serotonin-dopamine modulator Rexulti (brexpiprazole) from Otsuka Pharmaceutical Co. Ltd. and H. Lundbeck A/S for agitation in Alzheimer’s disease (AD) dementia, found favor April 14 at the joint meeting of the U.S. FDA’s Psychopharmacologic Drugs Advisory Committee (adcom) and the Peripheral and Central Nervous System Drugs Advisory Committee.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 2seventy, Abbvie, Affamed, Bristol Myers Squibb, Candel, Hanchorbio, Intelgenx, Lundbeck, Novo Nordisk, Otsuka.
Providing a much-needed lift to struggling Gamida Cell Ltd., the U.S. FDA has approved the firm’s advanced cell therapy Omisirge (omidubicel-onlv) to reduce the risk of infection in patients with hematologic malignancies aged 12 years and older who are scheduled to have umbilical cord blood transplantation.
The U.S. FDA has cleared Aroa Biosurgery Ltd.’s 510(k) for its Enivo pump and catheter, which are key components of the company’s new Enivo tissue apposition platform. The device applies negative pressure to a surgical site, helping to reduce fluid accumulation following surgery. It has been cleared for use in removing surgical and bodily fluids from a closed wound for hematoma and seroma prophylaxis following plastic surgery or other general surgeries where large flaps are formed.
Medicare coverage of medical devices in the U.S. sometimes is limited to a coverage with evidence development (CED) study, a process that may soon become more stringent. A recent advisory hearing on the CED process suggests that significant changes may be in the making, including a requirement that CED studies more closely reflect the demographic diversity of Medicare beneficiaries at large, a mandate that may force device makers to apply more resources to ensure that CED study enrollments fulfill that mandate.
After issuing three prior complete response letters, the U.S. FDA finally granted approval via the 505(b)(2) NDA pathway to Intelgenx Corp.’s Rizafilm Versafilm to treat acute migraine.