Drug Development
As drug candidates discovered via AI move into later-stage clinical trials, the technology seems to be doing as promised: speeding drug development.
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Three years after the accelerated approval of its anti-amyloid Alzheimer’s therapy, Biogen—neck and neck in the market with Eli Lilly and its Kisunla offering—is focused on a near-term FDA decision for a subcutaneous induction dose of Leqembi, a presymptomatic readout in 2028 and a clutch of next-generation candidates.
BMO analysts say Eli Lilly is well-positioned to maintain its lead in the ballooning weight loss space, predicting “strengthening leadership in obesity and beyond” as portfolios expand and patient access improves.
Facing the loss of exclusivity on key products, Pfizer has pulled forward its lead obesity asset into Phase III and targeted a 2028 launch. CEO Albert Bourla explained the pharma’s strategy at J.P. Morgan on Monday.
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The buyout comes on the heels of promising Phase I/II results from GTX-102, an antisense oligonucleotide candidate being developed to treat Angelman syndrome.
In what it is calling a strategic decision, Sesen Bio announced Monday that it has paused development activities of Vicineum, its lead asset, in the United States.
In the latest in Nestlé’s efforts to establish a presence in the gastroenterology space, the company will pay over $40 million upfront to Enterome as part of a new partnership.
MacroGenics’ Phase II trial shuts down after a patient death believed to be related to enoblituzumab combo, while Exelixis’ Cabometyx combo improves PFS in renal cell carcinoma.
Researchers point out that antibodies against amyloid are still considered an essential approach to treating Alzheimer’s, but the leading risk factor for sporadic AD is aging.
As a result of this new data, the company “has improved the statistical analysis of the ALLOB Phase IIb study.” The changes should speed up the overall recruitment and study.
Omega Therapeutics announced Thursday that the Investigational New Drug (IND) application for its hepatocellular carcinoma (HCC) candidate OTX-2002 has been granted by the FDA.
Clene, Inc. released data that shows its add-on treatment, CNM-Au8, significantly improved survival in patients with amyotrophic lateral sclerosis (ALS) by 70%.
Regeneron Pharmaceuticals and Sanofi announced positive results from a Phase III trial of Dupixent (dupilumab) in kids ages one to 11 years with eosinophilic esophagitis (EoE).
The FDA granted Novavax’s COVID-19 vaccine Emergency Use Authorization after a lengthy and obstacle-riddled journey. It is authorized as a two-dose primary series for adults 18 years and older.