It was a busy week for the U.K.’s drugs regulator, the Medicines and Healthcare Products Regulatory Authority (MHRA), which fast tracked decisions on novel drugs for cancer and eczema and made a ruling on booster COVID-19 jabs from Astrazeneca plc and Pfizer Inc. But even as Prime Minister Boris Johnson tweeted his support over the approval of Amgen Inc.’s cancer drug Lumykras, there are questions over the future of the regulator as it faces a round of job cuts because of a lack of funding following Brexit.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cantargia, Mirror.
The COVID-19 pandemic has exerted a significant effect on enforcement in the U.S., but Ethan Davis of King & Spalding (K&S) said federal prosecutors have made use of several novel approaches to prosecution in the past year.
China’s Personal Information Protection Law (PIPL) will take effect on Nov. 1, 2021, making it harder for tech firms, including health care companies, to access and use consumers’ personal information. The PIPL was officially passed by the National People’s Congress on Aug. 20.
Initial efforts at Humanigen Inc. to win an FDA emergency use authorization (EUA) for treating hospitalized COVID-19 patients with its monoclonal antibody, lenzilumab, have failed to gain the regulator's buy-in, sending company shares (NASDAQ:HGEN) down 47.3% to $7.97 on Sept. 9 after touching a 52-week low during the session, a reaction part of a volatile arc that has seen shares climb as high as $29.20 during the same time span.
The U.S. Department of Health and Human Services (HHS) reported a rescission of a September 2020 policy that would require that the secretary of health and human Services sign off on any rulemaking by HHS agencies. Despite the firestorm of criticism that followed the issuance of the September 2020 policy, attorney Jim Shehan, of Lowenstein Sandler, told BioWorld that the rulemaking process will remain exceptionally cumbersome, leaving in place a status quo that itself has been the target of repeated criticism.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alpha Cognition, Ascletis, Biomarin, Cormedix, Gensight, Global Blood, JW, Merck & Co., Moderna, RDIF, Underdog, Versantis.
China’s NMPA has approved JW Therapeutics Co. Ltd.’s relmacabtagene autoleucel, an autologous chimeric antigen receptor T (CAR T) therapy for the treatment of adults with relapsed or refractory large B-cell lymphoma (r/r LBCL) after two or more lines of systemic therapy. It marks the first CAR T product to be independently developed in China and approved as a category I biologic product there, as well as the sixth approved CAR T product globally. The anti-CD19 therapy, sometimes called relma-cel, will be marketed as Carteyva.
India’s drug regulator has approved 31 fixed-dose combination (FDC) drugs out of more than 300 banned products, after an assessment by its drugs technical advisory board. It has also asked for more phase IV postmarketing data for 19 others.
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