Legislation to reauthorize a number of U.S. FDA user fee programs has once again languished until the 11th hour, but the House and Senate committees of jurisdiction have apparently come to terms over the matter. However, the parties to this deal are characterizing it as a “clean” bill, which suggests that FDA regulation of lab-developed tests (LDTs) and a center of drug manufacturing of excellence will have to wait for another day or – because of the upcoming mid-term elections – most likely another year.
In recent years, ethicists have executed a 180-degree shift on including children in clinical trials testing drugs, biologics and medical devices, moving from the idea that it was unethical to include youngsters in trials to an understanding that such inclusion may be the best way of protecting them.
The race to become the first microbiome-based therapy to reach the market continues between two companies. A positive view by the U.S. FDA’s Vaccines and Related Biological Products Advisory Committee on Sept. 22 for RBX-2660 in preventing recurrent Clostridium difficile infection kept Ferring Pharmaceuticals Inc.’s microbiota-based live biotherapeutic moving forward.
Valneva SE is approaching a crucial point with its troubled efforts to develop a COVID-19 vaccine, having announced Sept. 26 it’s in talks with a potential partner for its next-generation jab. The company cautioned the negotiations could take several months and may not succeed. The company’s problems with its COVID-19 vaccine, which is based on an inactivated whole virus, have weighed on its shares (Paris:VLA), which collapsed from a 52-week high of more than €29 (US$28.29) in December 2021 to €5.74 at the close of trading Sept. 26.
Japan’s Ministry of Health, Labor and Welfare approved Daiichi Sankyo Co. Ltd.’s Ezharmia (valemetostat tosilate), the first dual inhibitor of histone methyltransferases EZH1 and EZH2 for the treatment of patients with relapsed or refractory adult T-cell leukemia and lymphoma. It’s Daiichi Sankyo’s fifth new oncology medicine approved in Japan in the past three years.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amniotics, Avenue, Bausch + Lomb, Biontech, Ferring, Glenmark, Infant Bacterial, Oncopeptides, Pfizer, Rebiotix, Spectrum.
While U.S. FDA approvals are down by 27% in 2022, the agency was busy throughout the month of September, clearing seven new molecular entities (NMEs), the most for any month this year.
The U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) took up the matter of Oncopeptides AB’s long-storied multiple myeloma (MM) drug, Pepaxto (melphalan flufenamide), and briefing documents ahead of the meeting – which provided little cause for optimism – proved predictive of ODAC’s vote. Shares of Oncopeptides (Stockholm:ONCO) have dropped more than 64% over the past five days as investor jitters worsened.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Keymed, Kinnate, Krystal, Merck & Co., Relief.
Emphasizing April’s vote of concern about the safety of PI3K inhibitors, the U.S. FDA’s Oncologic Drugs Advisory Committee said privately held Secura Bio Inc.’s Copiktra (duvelisib) is more of a hindrance than a help. The adcom voted 8-4 on Sept. 23 that it sees a detriment in overall survival (OS) and some other safety issues that were revealed in newly updated data for the cancer treatment. Approved in 2018 for treating adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least two prior therapies, Secura argued that its data continue to show a statistically significant and clinically meaningful benefit in OS and also in progression-free survival.
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