Rigel Pharmaceuticals Inc.’s ahead-of-deadline approval from the U.S. FDA of Rezlidhia (olutasidenib) twice-daily capsules for adults with relapsed/refractory (r/r) acute myeloid leukemia (AML) came as a surprise to the company, but followed encouraging interactions, “including a very positive midcycle review meeting,” said CEO Raul Rodriguez, adding that the firm will “redouble our efforts to make sure we're able to convey the information supporting this product” to the marketplace. Regulators had assigned the compound a Feb. 15, 2023, PDUFA date. Read More
Theratechnologies Inc. paused enrollment of a phase I trial testing TH-1902, its lead peptide-drug conjugate for sortilin-expressing cancers, after finding efficacy "not convincing enough" nor outweighing adverse events in some participants, an undisclosed number of which experienced neuropathy and eye toxicity, the company said. Read More
Anavex Life Sciences Corp. posted positive top-line data from its phase IIb/III study of ANAVEX 2-73-AD-004 (blarcamesine) in treating mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD. The oral small-molecule activator of the sigma-1 receptor (SIGMAR1) met the study’s primary endpoints and key secondary endpoint with statistically significant results. Read More
All gains made throughout the summer have vanished as the BioWorld Cancer Index (BCI) has hit its lowest point in 2022. Down 41.9% this year, BCI diverged in October from the path taken by both the Nasdaq Biotechnology Index (NBI) and the Dow Jones Industrial Average (DJIA), both of which are moving upward. Still, NBI is down 7.8% and DJIA is down 5.4% for the year. Read More
Ironically, one of the casualties of the COVID-19 pandemic is an overdue review and revision of U.S. dual use research of concern (DURC) policies, as well as the Department of Health and Human Services’ Potential Pandemic Pathogen Care and Oversight guidance. Consequently, several senators are asking the White House to halt all ongoing and new viral gain-of-function and DURC studies in the life sciences that involve enhanced pathogens of pandemic potential. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Amgen, CMS, Gadeta, Horizon, Immunocore, Incyte, Invitae, Neurocrine, Renovacor, Rocket, Sanofi, SQZ. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aldeyra, Aurinia, Bluejay, Citius, Eli Lilly, Ferring, Innoviva, Nuvectis, Oncolytics, Opus Genetics, Orchard, Pyxis, Scynexis, Sparingvision. Read More
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