Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Antengene, Bioniz, Gan & Lee, Huyabio, Landos, Mitoimmune, Ortho Regenerative, Tarus.
Citing the limited data for CAR T therapies in treating multiple myeloma, the Institute for Clinical and Economic Review said their cost-effectiveness for some patients will depend on whether a second dose is needed.
Acadia Pharmaceuticals Inc. President Serge Stankovic said the company was “kept completely in [the] dark” by the FDA regarding specifics about what the agency found wrong a month ago with the sNDA for Nuplazid (pimavanserin) – until, that is, the agency’s complete response letter (CRL) landed on the firm’s desk.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 89bio, Abbvie, Acadia, Exelixis, Eli Lilly, Passage, Supernus, Tetra.
The latest global regulatory news, changes and updates affecting biopharma, including: First thrombosis incident reported in Australia; FDA offers guidance on ANDAs during pandemic; FDA revises Moderna EUA; Fed Circuit’s indefinite ruling stands; BMS settles Medicaid rebate claims; GAO refuses to reconsider VA challenge.
LONDON – The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) stood by its view that the benefits of Astrazeneca plc’s COVID-19 vaccine “continue to outweigh the risks,” as it published the latest summary of reported adverse events.
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.
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