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.
Subscribe to ClinicaSpace
Clinical trial results, research news, the latest in cancer and cell and gene therapy, in your inbox every Monday
THE LATEST
The agency recommended another clinical trial be conducted to confirm the data from the study on the 3.2-mg dose of the intranasal carbetocin for Prader-Willi syndrome.
Amagma Therapeutics announced a licensing agreement with Innovent Biologics for up to three enzyme specific inhibitors derived from Amagma’s proprietary SEIZMIC Platform.
The company will continue to analyze data regarding the secondary endpoints.
The extensions are due to the FDA’s requiring more time to review additional clinical data it had requested from bluebird.
The decision to carry on came after dosing for the Phase III GENERATION HD1 trial was halted following an overall risk/benefit assessment.
Studies are ongoing in Israel on whether a fourth dose of an mRNA vaccine offers additional protection. Although the data is still early, it suggests that it might not.
The problem Kinaset is trying to solve is that over time, patients receiving asthma therapies – typically inhaled corticosteroids plus bronchodilators – become steroid-refractory.
While many of these scams targeted the public at large, scammers also turned their sights to those sources that would naturally be on the spot as the result of demand.
Expanded approval for Rinvoq was based on three Phase III studies that included more than 2,500 patients. The studies met all primary and secondary endpoints.
The Danish pharma giant is partnering with EraCal Therapeutics, to develop new obesity-related drug targets.