FDA Touts Speedier Pathway for Breakthrough Drugs; Hopes for Speedier Pathway for PDUFA V

Drug Shortages: Legislative Response Likely; Impact on Biopharma Sector Minimal

Drug Review Dossier: ridaforolimus

Advisory Committee Tracker: Safety Themes Dominate Fall Agenda; Will CATT Join List?

Biosimilars Update: Guidance Timing and Perspective on Equivalence

Express Scripts-Medco: Specialty Business Divestiture Would Be Major Negative For Merger

Biosimilar User Fee Agreement Set: Spending Trigger May Be Stumbling Block in Congress

Drug Review Dossier: tofactinib

The White House Deficit Reduction Plan and the Drug Industry: Go Big or Go Home?

Drug Review Dossier: Northera

FDA Committee Discusses CRPC Trial Design; Underscores Challenge for Amgen’s Xgeva Label Expansion, Other Future Sponsors

FDA Panel Review of Bisphosphonates: Consensus Is Not Enough Data

FDA Oncology Office Reshuffle: From Drug/Biologic to Disease Area

Joint Select Committee Organizational Meeting: Precedent is Important, Not Many Details Yet

Biopharma Fall Preview: Drug Approval News Flow Will Slow; Focus Shifts to Review Process

Xarelto Midday Update: Some Positives For J&J

J&J/Bayer Xarelto for Afib Will Miss Nov. 5 Deadline; Eventual Approval Likely

FDA Review Manager Opens Xarelto Panel Meeting Saying Agency Has Not Made a Decision On the Drug

Part D Rebates and the Deficit Reduction Supercommittee

FDA Advisory Committee Review of Bisphosphonates: Negative Attention Coming

J&J’s Xarelto Faces Unpleasant Options at FDA Advisory Committee: More Comparative Study or Limited Patient Population

PDUFA V Agreement: More Details About New Review Process, But No Big Surprises

Drug Review Dossier: Eylea

Advisory Committee Tracker: Xarelto Stroke Indication Headlines September Schedule

FDA Clinical Trial Monitoring Guidance Builds on Antibiotic Experience: Emphasis on Centralized Monitoring of Critical Data Elements