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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Biomarkers as a surrogate endpoint in ALS will go on trial on March 22 as Biogen and Ionis’s tofersen faces the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee.
On Feb. 28, Novavax issued a candid warning to investors: it may not be able to continue operations beyond February 2024. BioSpace takes a deep dive into the vaccine maker’s prospects.
For Daiichi Sankyo, recent results from the Phase III CLEAR trial of Esperion Therapeutics’ Nexletol (bempedoic acid) were not convincing enough to trigger a milestone payment.
Pfizer and Astellas announced positive topline Phase III results Thursday for Xtandi plus leuprolide in non-metastatic castration-sensitive prostate cancer.
The FDA will hold an advisory committee meeting for Sarepta’s investigational gene therapy for Duchenne muscular dystrophy ahead of its May 29, 2023 action date.
The new financing will help the Boston-based biotech accelerate the development of its siRNA-based therapies for immuno-dermatology indications.
Seamless Therapeutics launched Wednesday with $12.5 million in seed financing to develop its programmable recombinases for gene editing.
Bellicum Pharmaceuticals has ended the only clinical trials evaluating its GoCAR-T cell product in combination with rimiducid following serious safety concerns.
Mediar Therapeutics added another $85 million to its coffers Wednesday to take its first-in-class fibrosis therapies to clinic.
Weeks after the FDA rejected Veru’s Emergency Use Authorization bid for sabizabulin in COVID-19, the company announced plans to continue with late-stage development of the drug.