LONDON – A new route to the approval of drugs promises to smooth the path from clinical trials to approval, reimbursement and commissioning in the National Health Service, through closer and earlier collaboration between the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) and health technology assessment bodies.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Jemincare, Kite, Moderna, Ose, Regeneron, Tetra.
HONG KONG – SK Biopharmaceuticals Co. Ltd. partner Arvelle Therapeutics GmbH, now part of Angelini Pharma, has received European Commission (EC) approval for Ontozry (cenobamate), a treatment for drug-resistant focal-onset seizures. The approval was granted for focal-onset seizures with or without secondary generalization in adults who have not been adequately controlled despite a history of treatment with at least two anti-epileptic medicines.
U.S. lawmakers, advocacy groups and state officials who urged the Department of Health and Human Services (HHS) to march in on patents covering Gilead Sciences Inc.’s COVID-19 drug, Veklury (remdesivir), likely were disappointed, and perhaps surprised, by the Government Accountability Office’s (GAO) conclusion this week that, despite a $161.5 million taxpayer investment in the antiviral’s development, there are no government patents to march in on.
A new FDA approval for United Therapeutics Corp.'s prostacyclin analogue, Tyvaso (treprostinil), has expanded its label to include the treatment of pulmonary hypertension associated with interstitial lung disease to improve exercise ability. The regulatory win could double the number of patients taking the medicine by the end of 2022, barring any COVID-19-related delay, said company President and CEO Michael Benkowitz.
Zai Lab Ltd., China rights holder for the Deciphera Pharmaceuticals Inc. drug Qinlock (ripretinib), has obtained NMPA approval for the therapy, a treatment for adults with advanced gastrointestinal stromal tumors (GIST) previously treated with three or more kinase inhibitors, including imatinib, sunitinib and regorafenib.
In an unusual move, three members of the Nov. 6 FDA advisory committee that voted against recommending approval of Biogen Inc.’s high profile Alzheimer’s disease candidate, aducanumab, have doubled down on their argument in an editorial published in JAMA on March 31.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Autolus, Beyondspring, Lannett, Moderna, Neurophth, Respirent, Sanofi, Secura, Taiho, United.
“Our position has not changed,” said Emer Cooke, executive director of the EMA, giving an update on the agency’s investigation into cases of the rare clotting disorder cerebral venous sinus thrombosis (CVST) in people vaccinated with Astrazeneca plc’s COVID-19 vaccine. “There is no evidence to support restricting use of the vaccine in any population,” she said.
HONG KONG – Seikagaku Corp. and Ono Pharmaceutical Co. Ltd. have cleared the final hurdle for Joyclu (diclofenac etalhyaluronate sodium), with Japan’s Ministry of Health, Labour and Welfare granting manufacturing and marketing approval for the osteoarthritis (OA) therapy, the first agent to be approved in Japan for improving hip joint function in OA. The intra-articular injection was also approved for the treatment of knee joint OA.
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