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.
Clearpoint Neuro Inc. said Clinical Laserthermia Systems AB (CLS), snared a 510(k) from the FDA for a laser interstitial therapy system that will be marketed in the U.S. as part of the Clearpoint Prism Neuro system. This product package adds to a growing Clearpoint footprint in the neurological disorders space, adding to an inventory that already consists of targeted drug delivery and deep brain stimulation systems.
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 submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Clearpoint Neuro, Precisis, Pulse Biosciences.
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.
Colorectal cancer (CRC) is expected to increase steadily through the decade to reach more than 2.2 million cases and 1.1 million deaths by 2030 as two concurrent trends tick up—an aging population, that typically has higher rates of the disease, and an alarming increase in cases in younger people. Iterative Scopes Inc. hopes to help gastroenterologists find precancerous lesions before they progress with its Skout device, which received U.S. FDA 510(k) clearance this week.
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