Drug Development
Sanofi will take venglustat to regulators for Gaucher disease but an application for Fabry disease is less clear after the failure of a Phase III trial.
FEATURED STORIES
Together with robust data-driven modeling, rethinking regulation and data use could push forward a notoriously challenging field.
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.
As drug candidates discovered via AI move into later-stage clinical trials, the technology seems to be doing as promised: speeding drug development.
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Merck’s Keytruda won FDA approval for the treatment of patients with high-risk, early-stage triple-negative breast cancer. The approval marked the 30th for Keytruda.
The companies will co-finance a clinical study to test the combination of SHP2 inhibitor BBP-398 and OPDIVO in treating patients with advanced solid tumors KRAS mutations.
The company announced its Malaria project, part of the “eradicateMalaria” initiative led by the kENUP Foundation.
Today is the first day of the Alzheimer’s Association International Conference 2021 (AAIC), behind held both virtually and in person in Denver, Colorado. Here’s a look at some of today’s stories.
Just as it was beginning to appear safe to return to maskless, pre-pandemic life, the Delta variant of the SARS-CoV-2 virus emerged. It is fast-spreading, more likely to lead to hospitalizations, and accounts for most of the breakout infections among fully vaccinated individuals.
Bristol Myers Squibb (BMS) announced Friday its decision to withdraw from the U.S. market the indication for its immune checkpoint inhibitor Opdivo® (nivolumab) as monotherapy for hepatocellular carcinoma (HCC) in patients previously treated with sorafenib.
The FDA called for Iterum to conduct an additional clinical study that uses a different drug for comparison and to determine optimal dosing.
The FDA’s ODAC met to discuss retifanlimab and voted 13-4 that a regulatory decision for the drug for this indication should be deferred until more data was available.
Abeona Therapeutics’ shares popped 18.32% in pre-market trading after New York and Cleveland-based company announced magnetic resonance imaging (MRI) data from its Phase I/II Transpher A trial in San Filippo Syndrome Type A (MPS IIIA).
The company said its Allergan eye drops met both its primary and key secondary endpoints, with patients reporting near and intermediate improvements in vision.