Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Dizal, GBT, Merck & Co., Pfizer, Sellas, Trevena.
The U.S. FDA often has difficulty turning around draft guidances into final guidances in a timely manner, but that hasn’t impeded the agency’s appetite for fast turnaround of industry responses to FDA mandated postmarket surveillance studies. Nonetheless, the Medical Device Manufacturers Association (MDMA) said in comments to the docket for the May 2021 draft guidance for Section 522 postmarket surveillance studies that a requirement that such a study be fully enrolled within 24 months should be aspirational rather than compulsory.
Shares of TG Therapeutics Inc. fell 40% Jan. 27 after the firm disclosed in a U.S. SEC filing that the FDA had put a partial clinical hold on certain studies testing Ukoniq (umbralisib) and ublituximab, or the combination, for chronic lymphocytic leukemia and non-Hodgkin lymphoma.
In keeping with its Drug Competition Action Plan released in 2017, the U.S. FDA finalized two guidances this week focused on the submission and review of generic drugs.
The U.S. International Trade Commission (USITC) reported Jan. 26 that it will investigate whether Alvotech Hf and Teva Pharmaceutical Industries Ltd. misappropriated trade secrets when developing a potential interchangeable biosimilar to Abbvie Inc.’s mega-blockbuster, Humira (adalimumab).
Pfizer Inc.’s oral antiviral Paxlovid (nirmatrelvir) COVID-19 antiviral looks set for approval in the European Union after it was given the green light by its top regulatory committee. The EMA’s Committee for Medicinal Products for Human Use recommended conditional marketing authorization for treatment of COVID-19 in adults who don’t require supplemental oxygen but are at increased risk for progressing to severe disease.
PERTH, Australia – Australia’s Therapeutic Good Administration (TGA) plans to increase all fees and charges to industry by 2.6% for the 2022 to 2023 financial year, and it is seeking feedback on proposed options.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allergy, Ascletis, Cortexyme, Gilead, Hope, Ibio, Immunocore, Incyte, Molecular Targeting.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Maxim Biomedical.
With COVID-19 taking a toll on the U.S. FDA’s inspection program, warning letters stemming from drug facility inspections have been few and far between for the past two years. Aurobindo Pharmaceutical Ltd., of Hyderabad, India, was one of the exceptions.
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