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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kENUP had called the mRNA vaccine efforts in Africa “doomed to fail” since the project likely infringes on BioNTech and Moderna patents on the vaccine.
Shares of Alnylam Pharmaceuticals are sliding in morning trading despite the news that the company’s revenues grew by 83% in 2021 compared to the previous year.
Ardelyx has reported in a regulatory filing that the FDA sent an Appeal Denied Letter for its drug tenapanor, a therapeutic intended for chronic kidney disease.
It’s uncertain if the origins of COVID-19 will ever be determined, but the current top theories split about evenly between a lab leak from the Wuhan Institute of Virology and a natural evolution from bats to animals to humans at a Wuhan “wet market.”
The EUA request is based on the Phase II study that showed treatment with ensovibep reduced the viral load from the SARS-CoV-2 virus within eight days of use compared to placebo.
Merck has announced positive results from its Phase III KEYNOTE-522 study on the use of KEYTRUDA alongside chemotherapy in high-risk early-stage triple-negative breast cancer.
REGENXBIO presented results from its ongoing Phase I/II trial of RGX-111, an investigational one-time gene therapy for people with Mucopolysaccharidosis Type I (MPS I).
Biopharma and life sciences organizations from across the globe provide updates on their businesses and pipelines.
Johnson & Johnson has temporarily paused production of its COVID-19 vaccine at its manufacturing site in The Netherlands.
A week after Novavax submitted its Emergency Use Authorization materials to the FDA for its COVID-19 vaccine candidate. reports are coming out about the company’s problems with the production and delivery.