Drug Development
Infigratinib topped “even the most optimistic expectations” for efficacy and safety in the late-stage PROPEL 3 study in achondroplasia, Truist Securities analysts said Thursday.
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Analysts, investors and scientists are eager for Biogen’s 2026 BIIB080 readout. Even if successful, executives warn that there are many more steps before the Alzheimer’s therapy could reach the market.
With a clutch of key data and planned regulatory applications this year from Avidity Biosciences, REGENXBIO and Capricor Therapeutics, CureDuchenne CSO Michael Kelly sees “momentum” in the Duchenne muscular dystrophy pipeline, as Sarepta’s Elevidys leaves the door open.
After advancing in lockstep through the pandemic, the fortunes of the biotechs have diverged as their use of COVID-19 windfalls has taken shape.
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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.