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.
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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.
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In a double data drop Thursday, AbbVie touted two clinical trial wins, for Skyrizi in ulcerative colitis and Rinvoq in systemic lupus erythematosus.
Sanofi and Regeneron’s Dupixent (dupilumab) met its primary and all secondary endpoints in the Phase III BOREAS trial, significantly reducing severe exacerbations in COPD.
The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted 9-0 that tofersen’s effect on neurofilament light chain (NfL) could be a reasonable predictor of clinical benefit.
Data from the Phase IIb ENLIVEN trial showed 89bio’s pegozafermin met its primary histology endpoint in NASH patients, giving the company an edge in the competitive space.
Yescarta is the first treatment in nearly 30 years to improve overall survival in relapsed/refractory large B-cell lymphoma R/R LBCL, according to Gilead’s Kite Pharma.
Mayank Mamtani, managing director and group head of healthcare research at B. Riley Securities, told BioSpace he believes Altimmune’s pemvidutide still shows promise despite safety concerns.
Following recent meetings with the FDA and European Medicines Agency, Mereo Biopharma is designing a Phase III study of alvelestat to treat alpha-1-antitrypsin deficiency-associated lung disease.
Peter Marks described the steps the agency is taking to advance the development of gene therapies for rare disorders. This could spell good news in the near future for Sarepta Therapeutics.
Takeda will advance its experimental drug for plaque psoriasis, TAK-279, to Phase III later this year after the TYK2 inhibitor met its primary and secondary endpoints in a Phase IIb study.
Karuna Therapeutics released data Monday from the Phase III EMERGENT-3 trial showing that KarXT met the primary endpoint, significantly improving symptom severity.