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.
Subscribe to ClinicaSpace
Clinical trial results, research news, the latest in cancer and cell and gene therapy, in your inbox every Monday
THE LATEST
Novavax announced today that its protein-based Covid-19 vaccine, NVX-CoV2373, is included in two new clinical trials that will evaluate the vaccine as a potential Covid booster.
Although it was relatively quiet in COVID-19-related clinical trials, there was plenty of other clinical trial news. Here’s a look.
The FDA recommends a randomized trial to adequately assess drug efficacy and safety of P13K inhibitor drug candidates.
The FDA delayed Bristol Myers Squibb’s (BMS) target date for Reblozyl, approved the company’s melanoma drug and Japan accepted BMS’ NDA for Breyanzi.
Small Pharma Inc. is developing a new approach to treat major depressive disorder (MDD) without using SSRIs or standard medications. Here’s what they are using.
In honor of March 24, World TB Day, BioSpace looks at clinical trials and eradication efforts occurring today.
The Phase II trial is evaluating zepzelca as a monotherapy in patients with urothelial carcinoma, large cell neuroendocrine carcinoma of the lung and HRD tumors.
AstraZeneca shared that using imfinzi alongside chemoradiotherapy did not meet statistical significance in improving progression-free survival versus using CRT alone.
A recent study in mice was able to halt memory decay in a model of Alzheimer’s disease. Another study found that even mild infection increased the risk of new-onset type 2 diabetes, although the risk increased with the severity of COVID-19.
The U.S. Food and Drug Administration rejected Eli Lilly’s Biologics License Application, issuing a Complete Response Letter for the company’s PD-1 checkpoint inhibitor sintilimab.