Drug Development
Roche said the Phase II results help build the case for advancing CT-388 into late-stage testing, which is set to get underway this quarter.
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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Evidence continues to accumulate suggesting that Omicron, although significantly more infectious than previous COVID-19 strains, causes less severe disease.
More than 103,000 people in the U.S. were hospitalized on January 3, 2022, for COVID-19—the highest daily figure of hospitalizations since last summer when the Delta variant emerged.
AVROBIO is switching priorities in 2022 away from its Fabry disease program and into its other more lucrative clinical-stage projects.
While women are more statistically susceptible to autoimmune diseases, the research found that men with at least a mild COVID-19 infection had far more autoantibody (AAB) reactivity.
The FDA decided to lift the hold for its Phase IIa trial of SPR720 after Spero submitted a comprehensive analysis from the NHP toxicology study.
Biogen exercised an option to pick up an exclusive global license for a drug to treat spinal muscular atrophy from Ionis. The compound, BIIB115, is an antisense oligonucleotide.
Today, the FDA approved two new drug applications. One is for Spero’s tebipenem HBr oral tablets and the second is CStone’s IND application for CS5001.
Applied Therapeutics said it is holding off on a New Drug Application after discussions with the FDA, which appears to require additional clinical data.
Novavax vaccine’s emergency use authorization application has been submitted to FDA recently. Novavax is hoping to bring it to the Finish Line in 2022.
Low-income countries still struggle to get first jabs into arms. Researchers and pharma companies continue to push for low-cost vaccines and drugs worldwide.