Drug Development
Biogen touted an “unprecedented” drop in tau in a Phase 2 trial, backing the company’s decision to take diranersen to Phase 3 despite a missed primary endpoint and seemingly supporting the anti-tau approach.
FEATURED STORIES
Psychedelics are gaining momentum in depression, with one treating physician predicting that the drug class could “wipe out the SSRIs” if safety and durability hold up.
Saol Therapeutics is the latest biotech to resubmit for approval of a drug rejected under former FDA Commissioner Marty Makary, following REGENXBIO and Replimune.
After debuting on the public markets with $256.3 million and raking in an additional $472 million, Veradermics has emerged as one of biotech’s biggest post-IPO standouts. CEO Reid Waldman credits the weight loss craze for establishing consumer-driven channels.
Subscribe to ClinicaSpace
Clinical trial results, research news, the latest in cancer and cell and gene therapy, in your inbox every Monday
THE LATEST
Phase III KEYNOTE-671 study data showed Merck’s Keytruda improved event-free survival, one of the trial’s primary endpoints, in patients with stage II, IIIA or IIIB non-small cell lung cancer.
Citing lack of efficacy evidence, the FDA rejected Cytokinetics’ heart failure hopeful omecamtiv mecarbil in a decision announced Tuesday evening.
Wednesday, the FDA’s VRBPAC agreed that GSK’s respiratory syncytial virus vaccine candidate is safe and effective in older adults.
Aptinyx’s NYX-458 fell short of the primary endpoint in a Phase II trial of patients with cognitive impairment associated with Parkinson’s disease and dementia with Lewy bodies.
Theravance Biopharma is discontinuing research activities for its JAK inhibitor program in lung inflammation and reducing its headcount by about 17%.
Researchers at Kyverna Therapeutics and Cabaletta Bio hope to repurpose CAR-T cell therapy for patients with autoimmune diseases.
Billy Dunn, director of the FDA’s Office of Neuroscience, is stepping down from his post to “explore other opportunities,” according to an internal FDA e-mail.
ALS is the 5,000-piece jigsaw puzzle of the therapeutic world. As the regulatory edges come together, new research pieces are also connecting.
The hits kept coming for the sickle cell disease space last week as the FDA placed a full clinical hold on Fulcrum Therapeutics’ Investigational New Drug application FTX-6058.
Rezpegaldesleukin, Lilly’s and Nektar Therapeutics’ candidate for systemic lupus erythematosus, fell short of its primary efficacy endpoint in the Phase II ISLAND trial.