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
Allakos reported mixed results on two clinical trials, the Phase II ENIGMA 2 and Phase II/III KRYPTOS trials of lirentelimab.
Novartis believes Gyroscope’s investigational Phase II gene therapy for geographic atrophy has the potential to become the first therapy that demonstrates sustained efficacy for GA patients.
Ten studies are halted completely. Oral formulations of the drug will continue. Gilead stated that it is confident about the future of the drug’s potential and is working to resolve the vial quality problem.
In the last week, Omicron is credited for 73% of new COVID-19 infections and is accounted for 12.6% of positive cases, making it the most rapidly spreading variant the country has seen yet.
Pfizer has paused screening and dosing of a Phase Ib study of its experimental gene therapy treatment for Duchenne muscular dystrophy following the unexpected death of a patient.
After last week’s avalanche of clinical trial news associated with the American Society of Hematology Annual Meeting, there are far fewer announcements, but some companies are getting their news out ahead of the holidays.
ViiV Healthcare announced that the FDA approved Apretude, a long-acting injectable pre-exposure prophylactic option to reduce the risk of sexually acquired HIV-1.
Going through the most newsworthy stories of the year, BioSpace found trends more than one big story, topics that just kept rising again and again. Here’s a look.
Nasal spray vaccine delivery for COVID-19 has been explored by multiple companies since the beginning of the pandemic.
Moderna has decided to drop the patent application to “allow more time for discussions with the NIH”, which will be aimed at an amicable resolution.