Clinical research
BrainStorm Cell Therapeutics said it will submit a Biologics License Application to the FDA for ALS hopeful NurOwn. Additionally, a correction has been made to analyses of the Phase III clinical trial.
This week holds moments of truth for Provention’s type 1 diabetes drug and bluebird bio’s gene therapy for beta-thalassemia. Amicus and Incyte are coming up at the end of the month.
Roche Wins Approval for Flu Drug in Young Children, Pfizer Touts Positive Results for Infant Vaccine
Roche and Pfizer shared positive news from their respective forays into a new pneumococcal vaccine for infants and a treatment for influenza in small children.
AstraZeneca and Daiichi Sankyo’s Enhertu has been approved by the FDA as the first HER2-directed medicine for the treatment of patients with HER2-mutant metastatic NSCLC.
Amgen announced two lung cancer studies with mixed results, Innovent dosed the first patient in a Phase I diabetic macular edema study and HUTCHMED hit the primary endpoint in colorectal cancer.
Centessa halted ZF874 following the report of an adverse event that involved elevated liver enzymes in a Phase I study. This is the second development program the company has stopped in as many months.
Vyne Therapeutics’ combination therapy for atopic dermatitis failed to meet the primary endpoint in a Phase II trial, leaving the company evaluating its priorities and pipeline.
MaaT Pharma announced that the U.S. FDA has maintained the clinical hold on MaaT013, its candidate for patients with steroid-resistant acute graft-versus-host disease.
Using Cerevance’s proprietary NNETSseq technology platform, Merck and Cerevance have partnered to identify new targets for the treatment of Alzheimer’s disease.
BeiGene and Novartis’ unresectable hepatocellular carcinoma treatment, Tislelizumab, is gaining ground as a potential treatment for advanced liver cancer.
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