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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The FDA said Orencia is the first drug approved as prophylaxis for aGVHD prevention that included real-world evidence as one component of clinical efficacy.
Sanofi and GlaxoSmithKline reported that their potential COVID-19 booster shot delivered good immune response in its preliminary clinical trials.
The FDA approved the latest indication for Rinvoq (upadacitinib) based on data from two Phase III studies, SELECT-PsA 1 and SELECT-PsA 2.
Although it’s not yet clear how dangerous the Omicron variant of COVID-19 actually is, it clearly is very infectious and rates are rising in the U.S. and around the world.
These results set Lilly up well to submit a Biologics License Application (BLA) in the first half of 2022.
The FDA’s approval of Xeljanz is based on Pfizer’s Phase III multicenter, double-blind, placebo-controlled study. Here are more details about the study.
The JP Morgan Health Care Conference is held annually in January, and usually kicks off the biggest biopharma business news stories of the year. But in 2022, it’ll do so without at least three big names in the industry.
The FDA said that it is not authorizing molnupiravir’s use during pregnancy as there are hardly any clinical scenarios where the benefits appear to outweigh the risks.
Novartis has grown weary of waiting, dropping out of its deal to fund Mesoblast’s floundering COVID-19 treatment.
The lawsuit was filed by Public Health and Medical Professionals for Transparency, a nonprofit organization recently formed with a mission to obtain the data for the COVID-19 vaccines.