Drug Development
The mixed data from the Phase III COAST 2 trial follows an underwhelming data drop from COAST 1 in September that Leerink Partners said “fell well below expectations.”
FEATURED STORIES
Following the hard-won success of early anti-amyloid drugs, a new generation of Alzheimer’s modalities—from tau-targeting gene silencers to blood-brain barrier delivery platforms—is entering the pipeline to anchor future combination therapies.
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.
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The FDA requested additional data analyses from the pediatric studies that Merck stated it has submitted. The final decision is expected on July 1, 2022.
Although the data suggests the vaccines are extremely effective and generally safe, analysis is still coming in about adverse events as well as effectiveness in specific patient populations.
Cerevance reported positive clinical trial results for CVN424, an experimental treatment for Parkinson’s disease.
Origami’s precision technology platform, Oricision™, is focused on diseases that affect the central nervous system rather than oncology.
Vertex Pharmaceuticals has announced meaningful results from two Phase II studies of its therapeutic VX-548. It is a non opioid pain medication that promises results.
Taysha Gene Therapies announced that it will focus its efforts on clinical programs targeting Rett Syndrome and giant axonal neuropathy (GAN), resulting in a 35% reduction in its workforce.
CAR-T cell therapy is still a time-consuming and expensive process. But researchers may have just solved the turnaround-time challenge for CAR-T.
The U.S. FDA placed a partial hold on CytoDyn’s HIV program and a full clinical hold on its COVID-19 program in the U.S.
It’s a promising day for advanced ovarian cancer research as two biopharma companies achieved positive results. Here’s what you need to know about research.
In a meeting of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee, six members voted not to approve the NDA for Amylyx’s ALS candidate, AMX0035, while four voted in favor.