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.
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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 FDA is calling the study a phase II trial and says the company must run a rodent genotoxicity study before it can continue.
Although most of the news about the effectiveness and endurance of COVID-19 vaccines has focused on antibody titers, not as much has been reported on their effect on other parts of the immune system that offer longer-term protection, such as T cells. For that and more, continue reading.
Pfizer hopes to step in to ensure that no trade secrets are disclosed when the regulatory agency begins to share that information.
Biogen and its partner Eisai Company released additional details about the Phase IV post-marketing study of the drug.
The researchers believe Keytruda and possibly other anti-PD-1 checkpoint inhibitors might help the immune system track the last signs of HIV while also preventing HIV’s ability to hide.
In the last two years, the sheer volume of scientific research focused on COVID-19 has been astounding—thousands of clinical studies, dozens of vaccines and new compounds, and hundreds of approved drugs tested for efficacy against COVID-19.
Some might go as far as to consider the pharmaceutical industry as mankind’s best hope for survival. But now, as the world enters the third year of the pandemic, has that perception changed?
Biopharma and life sciences companies from across the globe provide updates on their businesses and pipelines.
Cortexyme said it plans to provide additional updates pending further talks with the FDA.
Incyte’s decision follows consultation with the FDA, where it decided that it could not support any confirmatory studies that might be required in the future given the limited time frame.