The U.S. Court of Appeals for the Federal Circuit struck a blow Nov. 30 to Biogen Inc.’s blockbuster multiple sclerosis (MS) drug, Tecfidera, affirming a lower court’s determination that a patent claiming a method of treating MS was invalid for lack of written description. In two other precedential cases the next day, the appellate court opened the door for Arbutus Biopharma Corp. to seek royalties on Moderna Inc.’s COVID-19 vaccine.
Tot Biopharm International Co. Ltd.’s self-developed Pusintin (bevacizumab), a biosimilar to Roche Holding AG’s Avastin, has won marketing approval from China’s NMPA. It was approved for the treatment of patients with advanced, metastatic, or recurrent non-squamous non-small-cell lung cancer and those with metastatic colorectal cancer.
The U.K. is stepping up its response to the Omicron COVID-19 variant after the country’s regulatory agency approved Xevudy (sotrovimab), the antibody therapy from Glaxosmithkline plc and Vir Biotechnology Inc. At the same time the country placed orders for 114 million more doses of COVID-19 vaccines from Pfizer Inc. and Moderna Inc., for use in 2022 and 2023.
The FDA’s device center is required to develop and publish special controls for devices that are deemed class II items via the de novo petition process, and five such declarations were posted Dec. 1 to the Federal Register. One of these de novo classifications, for conditioning tools for eating disorders, was the subject of a de novo petition filed in 2007 and granted in 2011.
The FDA granted 510(k) clearance to Metame Health Inc.’s Regulora, the company’s prescription digital therapeutic (PDT) for abdominal pain associated with irritable bowel syndrome (IBS). Regulora provides gut-directed hypnotherapy in a smartphone app that is designed to help patients better manage their symptoms and address miscommunication between the brain and gut that contributes to sensations of pain.
TORONTO – Koios Medical Inc. has received Health Canada approval for its DS Smart Ultrasound decision support software, which the company said accurately interprets breast ultrasound examinations. Company CEO Chad McClennan told BioWorld greater accuracy will provide early cancer detection rates, while reducing costly false positives and unnecessary biopsies.
Device makers have historically struggled to maintain adequate procedures for corrective and preventive action (CAPA) and complaint handling (CH), and two warning letters posted to the FDA website suggest these are still sore spots. Invacare Corp., of Elyria, Ohio, and Smiths Medical ASD Inc., of Minneapolis, were both cited for CAPA and CH deficiencies.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Directed Systems, Invo Bioscience, Immersivetouch, Reflexion.
One of the biggest concerns at the Nov. 30 meeting of the FDA’s Antimicrobial Drugs Advisory Committee is that, if Merck & Co. Inc.-Ridgeback Biotherapeutics Inc.’s antiviral drug, molnupiravir, is authorized for use in treating mild to moderate COVID-19 in patients at high risk of progressing to severe disease, it might be used too broadly, given its potential risks.
Beyondspring Pharmaceuticals Inc. said it received a complete response letter from the FDA regarding the NDA for plinabulin, the company’s lead asset. The FDA said results of a phase III registrational trial were strong enough to show benefit but a second trial is needed to satisfy the agency.