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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San Diego-based Endeavor BioMedicines closed on a Series B financing worth $101 million.
After reviewing available data, Bayer decided to abandon its Phase II development of eliapixant as the benefit-risk profile was not worthwhile.
Business with customers in the pharma and biotech sector was a key revenue driver, said Thermo Fisher CEO Marc Casper, adding that this business grew by 25% over the year.
COVID-19 is a respiratory illness and presents many other symptoms, including blood clots. For more details and other COVID-19 news, continue reading.
The FDA’s decision is based on favorable results from Sanofi’s Phase III CARDINAL trial, a 26-week open label, single arm study on 24 CAD patients.
COVID-19 causes certain conditions or is being implicated in their earlier onset. Type 1 diabetes and Parkinson’s disease are prime examples. According to researchers, it also may cause fetal inflammation.
For 2021, with $6.19 billion in sales the monoclonal antibody counted for a little less than one-third of Regeneron’s overall $16.07 billion revenue.
FDA Action Alert for February 7
Specialty vaccine company Valneva and Pfizer have reported positive Phase II data from their clinical trial evaluating a Lyme Disease vaccine candidate.
It was a relatively quiet week for clinical trial announcements. Here’s a look.