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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Bicycle Therapeutics and Novartis announced Tuesday they have inked a deal worth up to $1.7 billion to discover and develop targeted radioligand therapies in oncology.
Monopar Therapeutics is dropping its lead candidate, Validive, after it failed to meet efficacy markers in Phase IIb/III trials for severe oral mucositis.
Merck’s Keytruda appeared to outperform GSK’s Jemperli in a key endometrial cancer patient subgroup, based on late-stage data revealed Monday during the Society of Gynecologic Oncology 2023 Annual Meeting.
Despite a tough financing market, ArriVent Biopharma closed a $155 million Series B to fund a pivotal Phase III trial of its non-small cell lung cancer asset.
UNITY Biotechnology’s lead asset, UBX1325, failed to show non-inferiority to Regeneron’s blockbuster Eylea in a Phase II wet age-related macular degeneration trial.
Topline data from the Phase III NATALEE study showed Novartis’ Kisqali met its primary endpoint, reducing the risk of recurrence in early breast cancer.
The FDA approved Pharming’s leniolisib, now to be marketed as Joenja, for the treatment of the ultra-rare disease-activated phosphoinositide 3-kinase delta syndrome, the company announced Friday.
The FDA has granted an advisory committee meeting for BrainStorm Cell Therapeutics’ investigational ALS therapy, NurOwn, the company announced Monday.
Relmada Therapeutics announced it would make key changes to its clinical evaluation of REL-1017 as a possible add-on treatment for major depressive disorder.
Analysts point to a missed secondary endpoint and cardiovascular risks that may delay FDA approval as possible reasons for the unexpected drop in Karuna’s stock following the data reveal.