Japan’s Ministry of Health, Labour and Welfare approved the Regen-Cov (casirivimab/imdevimab, also known as Ronapreve) antibody cocktail for the treatment of patients with mild to moderate COVID-19 via intravenous infusion.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aldeyra, Ardelyx, Ionctura, Keiferx, Myovant, Octapharma, Sanofi, Swedish Orphan.
Albireo Pharma Inc.’s Bylvay (odevixibat) becomes the first therapy to hit the commercial market for rare genetic liver disease progressive familial intrahepatic cholestasis (PFIC). A day after the European Commission approved the drug, the FDA gave the nod to the ileal bile acid transport inhibitor on its July 20 PDUFA date following a priority review.
China’s Center for Drug Evaluation has released the guideline on developing oncology drugs with a clinical value-oriented approach, part of its ongoing efforts to encourage the development of truly innovative oncology drugs in China.
The China NMPA’s Center for Drug Evaluation accepted Lepu Biopharma Co. Ltd.’s new drug application (NDA) for anti-PD-1 antibody candidate HX-008 (pucotenlimab). That comes after the company filed for an IPO in Hong Kong.
The U.K. National Institute for Health and Care Excellence (NICE) said devices used to repair paravalvular leak around replaced mitral or aortic valves should only be used in studies because of a limited set of data on efficacy.
The European Commission has posted the first sets of standards for the European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The new publications had been long-awaited as more and more manufacturers leverage voluntary consensus standards to comply with requirements across regulatory bodies while promoting international harmonization.
The U.S. Centers for Medicare & Medicaid Services (CMS) had previously waded into a sea of opposition from device makers and medical societies alike in its proposal to eliminate the inpatient-only (IPO) list. The new administration at CMS has proposed to reverse that move and sustain the IPO, which should alleviate concerns that outpatient procedures will ding the reputations of these devices.
Fibromyalgia is an often debilitating condition, characterized by chronic pain throughout the body that can leave patients fatigued, depressed and unable to perform even the simplest of activities. While a handful of drugs have been approved to treat this autoimmune disorder, they can have unpleasant side effects and do not benefit all patients. To that end, the FDA has granted a breakthrough device designation to Neurometrix Inc.’s Quell wearable neurostimulation device for treating the symptoms of fibromyalgia in adults.
Regardless of the controversy swirling around the FDA’s accelerated approval of Biogen Inc.’s Alzheimer’s drug, Aduhelm, that U.S. approval is expected to open the door to more opportunities for Alzheimer’s treatments and diagnostics.
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