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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After months of speculation about looming layoffs, Biogen is handing out pink slips in order to save about $500 million.
Fulcrum Therapeutics will launch a Phase III study of losmapimod in people with facioscapulohumeral muscular dystrophy later this year. Tonix wins Orphan Drug designation for Prader-Willi asset.
APOE4 is associated with an increased risk of Alzheimer’s disease. A European consortium coordinated by the University of Geneva believes they have identified at least one mechanism of action.
Shares of NuCana have plunged more than 57% in premarket trading after the company announced its Phase III biliary tract cancer study. See more facts here.
The clinical trial, called SKYLINE, is starting without results from other key ongoing studies on the drug.
Healx brings the power of artifical intelligence (AI) to rare disease research with an ultimate focus on improving patient outcomes.
In the Phase III MELODY trial, researchers found a 74.5% lower incidence of respiratory syncytial virus-caused pneumonia, and bronchiolitis. Here’s more about it.
The FDA has not yet issued any hold orders to Cassava, but the company expects that its time is coming after rivals Denali and Cortexyme received theirs.
Recent gene therapy research has created a durable response in terms of producing normally-shaped red blood cells and reducing the pain of sickle cell disease.
The Phase III study showed that ELGN-GI not only improved gastrointestinal (GI) function, but it also reduced life-threatening complications.