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.
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Takeda’s vedolizumab met its primary endpoint in the Phase III GRAPHITE study, significantly improving event-free survival in patients with acute graft-versus-host disease.
Hemab Therapeutics announced the closing of an oversubscribed Series B round to bring new treatment options for lesser-known bleeding disorders.
If Leqembi is granted priority review from the agency, full approval could come as soon as July, Ivan Cheung, chairman and CEO, Eisai Inc., told CNBC Thursday.
Moderna announced mixed interim results Thursday from a Phase III trial of mRNA seasonal flu vaccine candidate, mRNA-1010.
Pfizer and Valneva are dropping approximately half of enrolled participants in the Phase III VALOR study for their Lyme disease vaccine candidate, VLA15.
One-year data from a Phase II study of Newron’s schizophrenia candidate evenamide showed sustained efficacy and continued improvements in symptoms of psychosis and disease severity.
Seagen did not address rumors of a buyout from Merck during its fourth-quarter and full-year financial report. Instead, it focused on upcoming label expansions and its promising pipeline.
Talaris Therapeutics is cutting one-third of its workforce and dropping two clinical trials studying its lead candidate.
Biogen’s 2022 fourth-quarter and full-year report comes the day after an additional warning on the company’s first Alzheimer’s drug came to light.
Enveda’s primary R&D efforts will focus on inflammation, fibrosis and neurosensory biology within the GI, dermatology and pulmonary therapeutic areas.