Postmarket Studies Archives

Biogen Bumps Up Diversity for Post-Marketing Aduhelm Trial

Advisory Committees, African-Americans, Alzheimer’s disease, Biogen, Business, Centers for Medicare and Medicaid Services (CMS), Clinical Trials, Diversity, Eisai, Ethnicity, FDA, Hispanics, Latino, Postmarket Studies, R&D, Therapeutics

While the Centers for Medicare & Medicaid Services undergoes the comment period on its national coverage decision for Biogen’s controversial Alzheimer’s drug Aduhelm (aducanumab), Biogen and its partner company Eisai released additional details about the Phase IV post-marketing study of the drug.

Roche Pulls Checkpoint Inhibitor in Bladder Cancer

AstraZeneca, Blockbusters, Checkpoint Inhibitors, Clinical Trial Endpoints, FDA, Metastatic Urothelial Carcinoma (mUC), Monoclonal Antibodies, PD-1/PD-L1 inhibitors, Postmarket Studies, Roche, Therapeutics, Voluntary Indication Withdrawal

Two weeks after AstraZeneca announced the company was withdrawing the use of Imfinzi as a treatment for bladder cancer in the United States, Swiss pharma giant Roche followed suit with the checkpoint inhibitor Tecentriq (atezolizumab).

Pfizer’s Xeljanz Fails to Meet Co-Primary Endpoint in Safety Study

Blockbusters, Clinical Trial Endpoints, Disease-Modifying Antirheumatic Drugs (DMARDs), JAK1 Inhibitors, Postmarket Studies, Primary Endpoints, Rheumatoid Arthritis, Safety Studies, Therapeutics, Tumor Necrosis Factor (TNF) Inhibitors

Pfizer announced in a statement that the prespecified non-inferiority criteria for a post-marketing safety study of the rheumatoid arthritis drug Xeljanz (tofacitinib) were not met, but the company remains hopeful that future analyses of the study will be more promising.