Drug Development
Fueled by advances in biomarkers, brain mapping, and AI, investment in neuro and CNS innovation shows no signs of slowing, even amid costly setbacks. BioSpace spoke to investors at JPM26 to get their take on recent bets in new therapies and neurotech.
FEATURED STORIES
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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Annexon released final data from an open-label phase II clinical trial, showing that its drug candidate ANX005 safely stabilized disease progression in patients with Huntington’s disease.
The Tisch MS Research Center of New York has been researching the concept of using cell therapy as a therapeutic strategy to promote repair and regeneration in certain patients with MS.
On Tuesday, the FDA’s Vaccines and Related Biological Products Advisory Committee voted 21-0 with one abstention to recommend authorization of Novavax’s COVID-19 vaccine.
Seres Therapeutics, Inc. announced that the company’s Phase III Ecospor IV study demonstrated a strong safety profile in addition to statistically significant positive results against C. difficile infection.
The Phase I mechanism of action study, showing that Lilly’s injectable Mounjaro (tirzepatide) induces greater weight loss than placebo and Novo Nordisk’s semaglutide in adults with type 2 diabetes.
Powered by its blockbuster checkpoint inhibitor Keytruda, Merck is forecasting a potential of more than 80 new regulatory approvals in oncology through 2028.
The Phase III ADvocate 1 and 2 studies on lebrikizumab showed that eight out of 10 patients with atopic dermatitis maintained skin clearance in the 12 months they had been under treatment.
BioSpace caught up with Tara Frenkl and Nelson Ambrogio ahead of ASCO to discuss Bayer’s goal of becoming a top 10 oncology company by 2030.
CEL-SCI Corporation, Jazz Pharmaceuticals, CARsgen and Ascentage Pharma presented clinical trial data at the American Society of Clinical Oncology 2022 Annual Meeting.
Sernova shared positive Phase I/II data from an ongoing clinical study of its implantable Cell Pouch device that showed evidence of in vivo active insulin production.