Endo Long-Acting Testosterone NDA Headed to Third FDA Rejection After Negative Panel Vote

GSK’s Breo COPD Exacerbation Benefit Outweighs Pneumonia Risk in Key Votes for Approval by FDA Committee

Part D Rebates Bill Brings Doc Fix Risk to Biopharma Though Odds of Enactment Still Low

FDA Denies OxyContin Generics: First “Abuse-Deterrent” Claim Given To Purdue Brand; Endo Opana ER Decision Still Pending

Compound Fracture: House GOP Attacks Will Slow Compounding Legislation; May Increase FDA Compliance Activities Across-the-Board

Endo Long-Acting Testosterone NDA is Long Shot at Advisory Committee; Reformulation Likely Necessary

GSK/Theravance Step-Skipping Development Program for Breo Is Issue for April 17 FDA Committee; Efficacy Data on Combo vs. LABA Single-Ingredient is “Not Entirely Consistent,” FDA Says

Medicaid Rx Budget Details: Line-Extension Rebate Fix Proposed But Not Explained; New Rebate Compliance Policies

FDA To Hold HIV and Lung Cancer Patient-Input Meetings in June; Full List for 2013-2015 Published

FDA Budget Request Underscores GDUFA Impact: Foreign Inspections To Increase; Generic Reviews Have More Resources

Obama Budget Proposal Adds Deeper Donut Hole Discount To Pharma Cuts; Part D Rebates Remain Big Ticket Item

Rx Compounding Legislation: Pressure Continues, But Enactment More Likely in 2017 Than 2013

House Animal Drug User Fee Act Hearing Focuses on Agricultural Antibiotic Use; No Mention of Rx Supply Chain or Compounding

CMS Nominee Tavenner Faces Few Drug Questions, Minimal Opposition in Finance Committee Hearing

Politics in Plan B Ruling Overshadow Implications for FDA’s New Nonprescription Switch Paradigm

“Breakthrough” Discussion Between Ariad and FDA Underscores Policy of Multiple Designations for a Single Indication

FDA’s Bob Temple Explains Accelerated Approval In Context of Broad Range of Special Tools to Expedite Development and Approval Processes: Webinar with Duchenne Patient Advocates

Biosimilars Meetings Guidance: Another Sign of Slow Start for Biosimilars But Reaffirms FDA’s Commitment to Get Sponsors onto New Pathway

FDA on Alzheimer’s Guidance: Focus Is on Early Disease, Not “Loosening” Guidelines

Controlled Substances Update: Abuse-Deterrent Labeling Guidance Moving Forward; FDA and DEA at Odds on Key Topics

Advisory Committee Tracker: GSK/Theravance Rescheduled Breo Review Headlines Light April Calendar

Pharma and Medicaid Expansion: ACA Opportunity Starts Near $3.5 Billion/Year in 2014, And Climbs From There

Mobile Apps in GOP Oversight Spotlight: Hearings Offer Template for Future Rx Focused Issues; Minimal Impact on FDA Policy

Titan’s Probuphine: FDA Advisory Committee Supports Approval; Timing Depends on Addressing REMS Concerns

Off-Label Communication Makes Short List for House Oversight of FDA in 2013; Hearings May Encourage FDA Policy Clarification