Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Arcellx, Biogen, Bioinvent, Bluerock, ERC, Fibrogen, Eli Lilly, Incyte, Pfizer.
The latest global regulatory news, changes and updates affecting biopharma, including: EC provides emergency funding for COVID-19 research; Final judgment against former Retrophin attorney; FDA hits company for deviations from drug, device GMPs.
Nearly 16,500 groups and individuals put in their two cents on a proposed National Institute of Standards and Technology (NIST) rule clarifying that the U.S. government, under the Bayh-Dole Act, can’t march in on patents derived from federally funded research just because it doesn’t consider the price of the resulting product “reasonable.”
The European Commission opened a public consultation to help it develop the Health Emergency Preparedness and Response Authority, a new initiative to better prepare Europe for cross-border health threats.
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.
RSS
