Cures Bill Moves To House Floor In Pharma-Friendly Fashion: Pay-Fors From Oil, Devices And Part D Plans; FDA Gets $550 Mil.

FDA’s Review “Program” Well-Received By Sponsors After Interim Assessment; Additional Communication Suggested

Breakthrough Denials Often Stem From Study Design Flaws, Accuracy Issues; FDA Applies Rigorous Early Review Process

21st Century Cures Markup Delayed One Day As Search For Pay-Fors Continues; Part B Drug Payments May Be One Focus

“Cures” Draft Finalizes FDA Provisions, But Lacks Pay-Fors; Merck/Cubist Would Benefit From Change To Antibiotic Section

340B Reform Draft Would Pre-Empt HRSA Guidance; May Not Make It Into “Cures,” But Still A Candidate For Enactment

Cures Act Moves To Full Committee: FDA Funding Still In Form Of Promises, Not Approps; Orphan Exclusivity Looks Safe

Ebola Vaccines: FDA Committee Supports Use of Immune Markers, Alternate Approval Pathways as Incidence Declines

GI Patient Feedback Meeting: FDA, Patients Discuss Improved Pain, Discomfort Measurement Methods

CMS Provisions Stripped Down In 21CC Manager’s Amendment

21st Century Cures Heads To Mark-Up: 6-Month Orphan Indication Exclusivity, Deadline For “Off-Label” Guidance Added

Vertex Orkambi Wins Strong FDA Committee Endorsement: Reversing Lung Decline Puts Small FEV1 Change In Context

FDA Updates Biosimilar Q&As: No Change To Interchangeability Statement, Adds Advice On Dosage Forms, Pediatric Plans

“Cures” Legislation Update: Senate Ready To Slow Down The Process

FDA Sets PDUFA VI Kick-Off Meeting For July 15; FDA/Industry Negotiations To Pick Up Where “Cures” Process Leaves Off

Vertex Challenge At FDA Ad Com On Orkambi Looks Tougher Than Previous Kalydeco Extensions: Is New Ingredient Needed?

DEA Responding To Congressional Criticism, GAO Oversight: Willing To Help FDA Plumb Use Of Quotas

Sprout Female Sexual Dysfunction Drug Heads To FDA Panel In June; Test Of Patient-Focused Meeting Impact On NDA Review

HHS OIG: Generic Inspections Up 20% In First Year Of GDUFA; Hospira, Wockhardt Singled Out For Enforcement Actions

Senate Precision Medicine Hearing Hits Positive Pharma Themes: Focus On Interoperability, Diagnostics – Not Drug Costs

FDA Draft Guidance Clean-Up: 14 Rx Items Withdrawn; FDASIA, Biosimilars, And Promotional Policy Update Explain Most

House Cures Bill Broadens Economic Discussions With Payers; Real Promotional Change Further Away In “Clinical Experience“

21st Century Cures Scorecard: What’s In, Out, Revised and Kept Untouched

Patients Urge Approval of Current Chagas Treatments; FDA Needs Sponsor to Bring Data Forward, Offers Up Precedent

House Opioid Hearing Returns To Old Theme For FDA: Whether and How To Make Prescriber Education Mandatory