Merck announced that LUSDUNA Nexvue, its injectable insulin glargine, has only received tentative approval from the FDA because of a lawsuit filed by Sanofi last September arguing Merck's drug infringes on its patent for Lantus. Merck will have to wait up to 30 months, or if a court rules in its favor, before the FDA can issue a final approval for the drug.
Amgen's biologics license application for Aimovig, or erenumab, to prevent migraine in patients who experience at least four migraines a month, has been accepted for review by the FDA with an expected action date of May 17, 2018. Amgen and Novartis will jointly commercialize the drug.
Braeburn Pharmaceuticals has filed with the FDA for priority status in its new-drug application for CAM2038, or buprenorphine depots, which is indicated for treatment of patients with opioid dependence. If approved, the drug would be provided in weekly or monthly dosing options in prefilled syringes.
Spark Therapeutics' Luxturna, or voretigene neparvovec, for treatment of patients with inherited retinal disease, received rare pediatric disease status from the FDA. The drug is under review with an action date of Jan. 12, 2018.
Incyte said it has begun treating its first patient in a late-stage trial to assess the efficacy of its Janus kinase inhibitor 1 drug candidate itacitinib to treat acute graft-versus-host disease combined with corticosteroids. The study's primary endpoint is overall response rate 28 days after dosing begins, while the secondary goal is nonrelapse mortality at six months.
All lots of Sten Z and M1 Alpha capsules, labeled as dietary supplements, have been recalled by Andropharm because they contain derivatives of anabolic steroids, making the products unapproved drugs. The recalled products come in capsule form, were packaged in 60-count bottles and sold from March 2016 to April 2017 in retail stores nationwide.
Patients at the Henry Ford Health System in Detroit were the first to undergo treatment procedures using the MRIdian Linac system from ViewRay, the company said. The device is a linear accelerator-based MRI-guided radiation therapy system that builds on the company's first-generation system.
The European Union approved LEO Pharma's Kyntheum, or brodalumab, as a treatment for patients with moderate to severe forms of psoriasis who are candidates for systemic therapy. The drug achieved 37% to 44% complete skin clearance in patients during week 12 of treatment versus 19% to 22% achieved with ustekinumab use.
The Powerheart G5 automated external defibrillator from Cardiac Science has been granted approval by Health Canada. The device, which is a combination of automatic shock delivery, variable escalating energy, rapid shock times and dual-language rescue prompting in English and French Canadian, enables effective response from first-time users and professionals to sudden cardiac arrest incidents.
The FDA's Center for Devices and Radiological Health provided clarification on how it will process requests for recognition of voluntary consensus standards for medical devices under the 21st Century Cures Act. The process will include a 60-day deadline for the FDA to respond to requests in written form and publication of the agency's rationale for nonrecognition or recognition of all or part of a standard in the Federal Register.
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