Drug Development
After a spate of patient deaths in 2025 linked to the company’s Duchenne gene therapy, Sarepta shared new data showing benefits of the therapy three years after dosing.
FEATURED STORIES
As drug candidates discovered via AI move into later-stage clinical trials, the technology seems to be doing as promised: speeding drug development.
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.
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The EMA’s safety committee has announced that they are reviewing reports of menstrual disorders after people received COVID-19 vaccinations from Pfizer-BioNTech and Moderna.
Shares of Cassava Sciences are up more than 5% in premarket trading after the FDA denied a Citizen Petition filed last year to suspend the company’s Alzheimer’s clinical trials.
New research published this week gives a greater understanding of why the CDC warned of an increased risk of stillbirth for women infected by SARS-CoV-2 during pregnancy in November.
New two-year data from Phase III studies of Susvimo and Vabysmo reinforce the two drugs’ potential to improve the quality of life of patients diagnosed with DME and nAMD.
On Feb. 15, the FDA’s Vaccines and Related Biological Products Advisory Committee is scheduled to discuss an amended EUA for the Pfizer-BioNTech vaccine in the under 5 age group.
CMS issued a draft decision for Biogen’s Alzheimer’s drug and said it would only cover the cost of Aduhelm and any required scans “if they are enrolled in qualifying clinical trials.”
The promising results from the pediatric expansion are what fuels Novavax’s next move to apply for regulatory approval for the 12-to-17-year age group by the first quarter of 2022.
The FDA’s Oncologic Drugs Advisory Committee (ODAC) has recommended 14-1 that the two companies conduct a trial applicable to the U.S. population.
The speakers extolled the benefits of telehealth while noting the challenges posed by a lack of high-speed Internet in some parts of the country.
Arkuda seeks to disrupt the usual progression of neurodegenerative disease with medicines developed by applying cutting-edge knowledge from the domains of lysosomal and microglial biology.