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’s decision is based on positive results from several Phase III studies, including the TENAYA and LUCERNE clinical trials.
Eli Lilly and Company announced that it was discontinuing the Phase III development program for Olumiant (baricitinib) in lupus.
The resubmission follows a Type B pre-BLA resubmission meeting with the US Food and Drug Administration (FDA).
Clinical trial news definitely picked up this final week of January. Here’s a look.
Researchers are expressing concern about a subvariant of Omicron dubbed BA.2 that appears to be tearing through Denmark. For that and more COVID-19 news, continue reading.
Taysha said the data for TSHA-101 is the “first-ever to support the bicistronic vector approach in humans delivering both HEXA and HEXB genes in the endogenous ratio.”
Moderna invested heavily in mRNA technology to manufacture some 900 million doses of the COVID-19 vaccine. Now, the company has created an mRNA-based vaccine to prevent HIV.
The company initiated the use of splenic nerve simulation last month as part of a small clinical trial at the NHS Greater Glasgow & Clyde Health Board in Scotland.
Alzamend Neuro is looking to commence a Phase II multiple ascending dose study of lead compound, AL001, in Alzheimer’s disease during the second quarter of this year.
The studies are of the U2 combination Ukoniq (umbralisib) and ublituximab for chronic lymphocytic leukemia (CLL) and non-Hodgkin’s lymphoma (NHL).