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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Merck posted a rare defeat Wednesday for its blockbuster Keytruda (pembrolizumab) in prostate cancer while simultaneously announcing a victory in biliary tract cancer.
Cassava Sciences reported Phase II data from its Alzheimer’s candidate simufilam Tuesday. The company’s stock dropped 17% following the reveal.
Results from a study published in PNAS demonstrated that delivering therapeutics intranasally was sufficient to enhance functional recovery in rat models of ischemic stroke.
Research hasn’t shown that removing amyloid plaques alone improves function in Alzheimer’s patients, said Sharon L. Rogers, CEO of AmyriAD.
Axcella Therapeutics’ Long COVID fatigue therapeutic is moving forward as the company received guidance from the MHRA and filed an IND with the FDA seeking a Phase IIb/III trial.
After reporting promising interim findings from the Phase IIa INTEGRIS-IPF trial, Pliant Therapeutics commenced a public stock offering of $175 million.
Rhythm Pharmaceuticals published data Monday showing Imcivree (setmelanotide) improved quality of life for patients with obesity related to Bardet-Biedl Syndrome.
Phase III data showed Ipsen’s Onivyde boosted overall survival in metastatic pancreatic ductal adenocarcinoma.
Thursday, Astellas announced that the FDA had lifted its clinical hold for the company’s experimental gene therapy trial for late-onset Pompe disease.
The FDA issued a complete response letter Thursday refusing accelerated approval for Eli Lilly’s Alzheimer’s disease candidate donanemab.