Generic Provigil: Teva Sole Generic Status Upheld; Court Says Antitrust Issues Are For Congress, Not FDA, To Address

Senate Manager’s Amendment Released: Includes Some Brand New Amendments; Still No Track-And-Trace, Special Pop

Drug Safety Report Comes Ahead of Final Senate PDUFA Hearing

FDA Provides Input On User Fee Draft Provisions; Track-And-Trace System’s Future Uncertain

Hatch Drug Shortages Draft Bill Goes After Reimbursement, Odds Close to Zero for PDUFA V

Generic Provigil: Teva Windfall Looks Safe After Court Date; Expect Ripple Effects On Other Brand/Generic Disputes and Policy

House E&C Discussion Draft Includes New Shortage Provisions; Still No Supply Chain

CMS Final Rule Codifies Coverage Gap Program, Clarifies Provisions

Health Care Reform: What if it All Goes Away?

The Supreme Court and Biopharma: Points for Consideration

Drug Review Dossier: Xarelto to Reduce the Risk of Stent Thrombosis in ACS

Astellas’ Mirabegron Overactive Bladder Treatment Gets “Yes” Approval Vote; Committee Emphasizes Further Monitoring

FDA Actively Conducting REMS Inspections; No Warning Letters Issued to This Point

Senate Approval/Access Draft Includes TREAT, Breakthrough Therapies Provisions, Adds Social Media Guidance Directive

Positive Effects of Flexibility & Phase IV: FDA's 2011 Approval Record - Prevision Policy Presentation

Drug Review Dossier: Xarelto for DVT, PE, prevention of VTE

Drug Review Dossier: Zohydro

Drug Review Dossier: pomalidomide

Senate Antibiotic, Drug Shortage Drafts Released; Still No “Special Pop”

No Surprises at Senate User Fee Hearing; Emphasis on Quick Reauthorization and Non-Controversial Add-Ons

Obesity Drugs Panel Supports Diabetes-Style Guidance: Good For Diabetes Cross-Over Sponsors, No Direct Impact on Qnexa

Obesity Drugs and Cardiovascular Outcomes: Points to Consider, Beyond the Vote

Advisory Committee Tracker: Pfizer Faces Two Big May Milestones

ACOs and Oncology Drugs: Opportunities and Challenges Under and Integrated Provider Model

Obesity Drugs Cardiovascular Outcomes Panel Unlikely to Derail Qnexa