Biomarker Qualification Pathway: White Paper On Assay Validation To Be Reviewed At Duke-Margolis Workshop

Biosimilar Launches Will Not Have Six-Month Stay After Supreme Court Ruling; “Patent Dance” Is Optional Under Federal Law

FDA Wants Endo To Pull Opana ER; Fits “More Forceful” Tone For Opioid Policy Under Gottlieb – But Also Shows Challenges Ahead

Opportunities In Orphan Biosimilars: Developers See Big Prospects In Small Markets; Alexion's Soliris Is One Target

House Energy & Commerce Unanimously Clears FDARA As Off-Label Communication Is Sidetracked, Drug Pricing Deflected

Friedreich's Ataxia Drug Development Should Include Pediatric Trials; Patients Seek Treatments Initially to Halt Progression

FDA Wants Endo To Pull Opana ER; Fits “More Forceful” Tone For Opioid Policy Under Gottlieb – But Also Shows Challenges Ahead

Weekly Highlights: June 5-9

Upcoming FDA Focus on Integration of Biomarkers in Drug Development; Future Meetings and Guidances Promised

HHS Budget Hearings: Drug Pricing Gets Scant Attention; Will Secretary Price’s Plan Be Enough To Defuse Debate?

House Energy & Commerce Unanimously Clears FDARA As Off-Label Communication Is Sidetracked, Drug Pricing Deflected

FDA Advisory Committee Tracker: First CART-T, Gene Therapy BLAs May Mean A Summer Of Personalized Medicine Panels

Valuing Drugs For Rare Diseases: ICER Discussion Shows Tying R&D And Profitability To Price Poses Risks For Industry

Weekly Highlights: May 30 - June 2

Biomarker Qualification: FDA Will Be More “Proactive” After Cures, PDUFA VI; FDA/NIH “BEST” Resource List Is Head Start

FDA Advisory Committee Tracker: First CAR-T, Gene Therapy BLAs May Mean A Summer Of Personalized Medicine Panels

Biomarker Qualification: FDA Will Be More “Proactive” After Cures, PDUFA VI; FDA/NIH “BEST” Resource List Is Head Start

A Nicer ICER: Sanofi, Regeneron Dupixent Pricing Praised During Review Of Eczema Drugs By Cost-Effectiveness Panel

What’s Up With ODAC? Rare Winning Streak for Sponsors May Be Sign Of Changes In How FDA Uses Oncology Advisory Committee

Weekly Highlights: May 22-26

FDA Drug Pricing Action Plan Coming Soon: Key Themes Focus On Generic Competition; Action On Orphan Drug “Loopholes” Urged

Pfizer’s “Epoetin Hospira” Biosimilar Headed To Approval; FDA Committee Urges Postmarketing Vigilance In Oncology, HIV

FDA Carries Emmaus Sickle Cell Application Through Committee; Agency Adds Rigor To Data To Show Reduction In Crisis Events

Puma Neratinib Easily Clears Committee; Amazing Turnaround For Once-Halted Program, With NDA FDA Didn’t Want Filed

Zika Vaccine Progress Subject Of House Hearing: Fast Scientific Response, But “Fair Price” Demands Face Sanofi