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 has rejected Cambridge, Mass.-based Akebia Therapeutics’ New D2rug Application (NDA) for vadadustat, a therapeutic for anemia due to chronic kidney disease (CKD).
A meeting with an amyotrophic lateral sclerosis (ALS) patient in Israel who could only speak with the assistance of a computer changed the life and direction of NeuroSense CEO Alon Ben-Noon.
Biogen will await word after submitting the final study protocol for its confirmatory Phase IV ENVISION trial of Aduhelm to the U.S. Food and Drug Administration (FDA).
A team at the University of California, San Diego developed a drug screening method to help determine why Alzheimer’s drugs fail. The system analyzes disease mechanisms in human neurons.
Researchers have developed a new form of UV light that is safe for people but decreased the level of indoor airborne microbes by more than 98% in less than five minutes.
Despite being represented in clinical research, no solutions have been found to circumvent the effects of Alopecia areata. However, there may be hope.
Although it looks that we’re on the downside of the COVID-19 pandemic in the U.S., biopharma companies are still working on developing better treatments and preventions.
Interim data from Genentech’s first randomized study on a candidate treatment for extensive-stage small-cell lung cancer failed to meet its co-primary endpoint.
Data from Clene’s RESCUE-ALS trial showed that treatment with CNM-Au8 significantly slowed progression of ALS and improved quality of life.
Without holding a meeting of its vaccines advisory committee, the U.S. Food and Drug Administration (FDA) authorized a fourth booster shot for everyone 50 years of age and older.