Phase III
Already approved in schizophrenia and bipolar depression, Intra-Cellular Therapies reported strong late-stage data Tuesday for its antipsychotic Caplyta in major depressive disorder.
While Madrigal Pharmaceuticals secured the first FDA drug approval for metabolic dysfunction–associated steatohepatitis, Akero Therapeutics is developing what may serve as a viable alternative treatment for precirrhotic disease.
Roche said Monday that its bispecific T cell engager Columvi improved survival in a Phase III lymphoma trial, clearing the drugmaker to seek a full, expanded label that could drive sales growth.
AbbVie’s small molecule drug Qulipta has durable benefits and can reduce migraine frequency through 48 weeks of follow-up, according to interim Phase III data released on Friday.
Late-stage study results released Tuesday show YS Biopharma’s rabies vaccine candidate can induce twice the seroconversion rate at seven days versus a standard, globally marketed comparator.
After BrainStorm Cell Therapeutics withdrew its BLA in October 2023 for NurOwn, the company announced Tuesday that the FDA has agreed to the design of a Phase IIIb trial for its amyotrophic lateral sclerosis candidate under a Special Protocol Assessment.
Pfizer’s respiratory syncytial virus vaccine Abrysvo is just as effective in younger adults aged 18 to 59 years as it is in the shot’s currently approved population of 60 years of age and older.
Novo Nordisk and Ionis Pharmaceuticals unveiled promising respective data at the American College of Cardiology’s Annual Scientific Session, while Boehringer Ingelheim and Eli Lilly’s Jardiance missed the endpoint in a myocardial infarction study.
Fresh off of its $14 billion acquisition of Karuna Therapeutics, Bristol Myers Squibb on Saturday reported promising late-stage data for Karuna’s antipsychotic KarXT, which elicited significant symptomatic improvement in schizophrenia symptoms.
2024 began with several biopharma players posting positive Phase III data that could mean new market share for the companies and longer survival times and quality of life for patients.
PRESS RELEASES