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.
Eyegene Inc. has received the green light from South Korea’s Ministry of Food and Drug Safety (MFDS) for EG-COVID, its mRNA COVID-19 vaccine, to enter the clinic. Eyegene will now begin a phase I/IIa trial, to be conducted in two stages, to evaluate the vaccine’s safety, tolerability and immunogenicity.
The FDA has put a hold on a clinical study of a rare disease gene therapy BMN-307 from Biomarin Pharmaceutical Inc. after several mice developed liver tumors following a high dose in a preclinical trial.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arctic Vision, Astrazeneca, Impel, Neuren, Oncopeptides, Pharmabcine, Supernus.
The FDA has approved Trudhesa (dihydroergotamine mesylate [DHE]; INP-104) from Impel Neuropharma Inc. for treating acute migraine headaches with or without aura in adults. The approval comes as several competitors, including Axsome Therapeutics Inc and Abbvie Inc., have NDAs submitted or approved for new therapies to treat migraine.
While the volume of regulatory data is above this point last year by more than 17%, the proportion of COVID-19-related news is nearly the same, as is the number of U.S.-approved new molecular entities (NMEs).
The European Commission and Astrazeneca plc have ended their legal row over COVID-19 vaccines, while also reaching an agreement over supplies of remaining shots to Europe. The settlement brings to an end an unseemly row over vaccine supply, which further soured relations between the EU and U.K. following Brexit.
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