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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BridgeBio Pharma reported topline data from Part A (Month 12) of its Phase III study of acoramidis for symptomatic transthyretin amyloid cardiomyopathy. The drug failed the study arm.
The company was assessing mavrilimumab as a potential therapeutic for COVID-19-related acute respiratory syndrome.
The FDA has greenlit Merck and Ridgeback’s molnupiravir under EUA to treat mild to moderate COVID-19 infections in adults at high risk of progression to severe disease.
Studies found that AstraZeneca’s EVUSHELD was still effective against the Omicron variant. EVUSHELD is a long-acting antibody combination made up of tixagevimab and cilgavimab.
The latest approvals mark the first time a biologic has been approved for ERA. Cosentyx is also the only biologic approved in the United States for both ERA and PsA in pediatric patients.
New real-world studies from Scotland and England shows that Omicron does not lead to as much hospitalization as Delta. This is consistent with the latest reports from South Africa that say Omicron causes milder disease.
PhaseBio’s move to suspend its Phase IIb trial of pemziviptadil is due to the effect of COVID-19 on manufacturing, associated drug supply, and the rate of enrollment in the study.
The U.S. Food and Drug Administration granted Emergency Use Authorization to Pfizer’s Paxlovid (nirmatrelvir and ritonavir tablets) for high-risk adults and pediatric patients 12 years and older to treat COVID-19.
Takeda hoped that its experimental therapy could become the first FDA-approved treatment for EoE. However, the FDA wants the company to initiate another clinical study with TAK-721.
The new Phase III study will include an enhanced version of the Viaskin Peanut patch, approximately 50% larger than the patch initially rejected by the FDA.