Drug Development
From opening new therapeutic mechanisms to repairing neuronal damage, investigational molecules from Ventyx Therapeutics, AC Immune, Gain Therapeutics and more could shape the future of Parkinson’s disease treatment.
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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With IND approval, the therapeutics have become the first LBPs for Parkinson’s disease cleared by the FDA.
Synairgen watched its stock plummet 85% after reporting disappointing Phase III results for its inhaled COVID-19 treatment on Feb. 21.
The COVID-19 pandemic and the virus that causes it, SARS-CoV-2, has been resilient, unpredictable and confounding from the very beginning.
The U.S. Centers for Disease Control and Prevention is under fire for failing to publish large swaths of hospitalization data related to the COVID-19 pandemic.
A new packaging and labeling manufacturing facility has derailed the potential approval of Malinckrodt’s investigational hepatorenal syndrome (HRS) treatment, terlipressin.
AstraZeneca and Daiichi Sankyo released positive data from their Phase III trial of Enhertu. An alternative to chemotherapy for some HER2 low breast cancer.
It was noted early in the COVID-19 pandemic that the disease was peculiar — not only was it a respiratory disease, but it created hyper-immune responses.
The FDA asked Homology Medicines to modify the pheNIX gene therapy trial’s risk mitigation measures to prevent any serious issues that may arise.
The end of February picks up significantly from early this year for the U.S. Food and Drug Administration and its PDUFA dates.
Clinical Catch-Up for February 21