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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Six months after the one-time treatment, 47% of patients in Cohort 1 demonstrated a promising two-step or greater improvement in their diabetic retinopathy.
CMS says it would only cover the cost of Biogen’s Aduhelm and any required scans “if they are enrolled in qualifying clinical trials.”
ProQR Therapeutics has reported that their drug sepofarsen failed to meet its primary and secondary endpoints in recent Phase II/III clinical trials.
The planned testing for DNL919 was held back pending additional documentation required to initiate the studies and information on the preclinical toxicology assessment.
Although the Omicron surge appears to be waning in the U.S., the World Health Organization keeps an eye on four Omicron subvariants.
Eli Lilly’s proposed antibody drug bebtelovimab has received EUA from the FDA after demonstrating its potency against SARS-CoV-2’s Omicron variant.
Exo Therapeutics’ approach is not only different, it has revolutionary potential.
Pfizer indicated it will wait for the full data on a three-dose series of the vaccine for that population, believing it “may provide a higher level of protection in this age group.
Curevo, a clinical-stage biotechnology company, is developing safe and highly-effective vaccines to fight infectious diseases such as shingles.