Biosimilar Reimbursement Sweetener May Be Added To “Product-Hopping” Bill; House Hearing Features Testimony On Nuance Of Defining Anti-Competitive Conduct

House Part D Inflation Penalty Uses AMP, Rather Than Senate’s “WAC” Approach; HR3 Text Shows “Negotiation” Plan Is Even Worse Than It Sounds

“This Stuff Is Hard”: FOCR Real-World Evidence Collaboration Demonstrates The Promise – And Challenges – Ahead, FDA’s Abernethy Says

Prevision Policy Clips | Complex Innovative Trial Design Draft Guidance

House Unveils Rx Price Dictation Bill: Once-Unthinkable Policy Moves To Mainstream – But Big Difference Between Campaign Posture And Making Law

Beyond Price Negotiation: Key Items In House Bill Include $2,000 Out Of Pocket Cap In Part D, 10%/30% Mandatory Pharma Discounts

FDA Unveils Tech Revamp Championed By Deputy Commissioner Abernethy; Timelines Coincide With Key Funding Cycles

NDAC Recommends Approval Of GSK OTC Nicotine Spray With Trepidation Over Efficacy, Youth Abuse Potential

Prevision Policy Clips | House Drug Price Negotiation Bill: First Stop Will Be Energy & Commerce/Health Subcommittee

Pain Drug Developers Have List Of Incentive Requests For FDA, Congress; “Opioid-Sparing” Indication, “Breakthrough” Clarity Are Most Viable

FDA Opioid Framework: Agency Hears Calls To Re-Review All Marketed Products – And Consider Non-Opioid CNS Products As Well

Prevision Policy Clips | Senate Approps Full Committee To Meet September 19 To Consider FY2020 Ag/FDA Bill

Parallel Multi-National Review Becomes Reality At FDA With OCE-Led “Project Orbis” Approval Of Eisai’s Lenvima With Merck’s Keytruda

Prevision Policy Clips | Priority Review For Merck Ebola Vaccine

Regional/National Risk Pools For High Cost Therapies Get Support From Former FDA, CMS Officials Gottlieb and Conway

Biopharma Congress V

GSK OTC Nicotine Mouth Spray: Dark Clouds Around Vaping Should Help NDA Under Traditional Regulatory Model At FDA Panel

Aimmune’s Palforzia Peanut Allergy Therapy Clears Committee, Conditioned On REMS To Assure Supervision Of Dose-Escalation, Access To EpiPen

Prevision Policy Clips | Dueling Positions On Drug Pricing: PhRMA Supports Part D Out of Pocket Caps, Sharing Rebates At the Point Of Sale In Senate Finance Bill

Expanded Access Concerns Continue Despite FDA’s Best Efforts: Firms Remain Wary Of Compassionate Use, Broader Clinical Trial Eligibility, GAO Finds

Medicaid “Best Price” Reforms To Enable Value-Based Contracts: Administrative Change Is Only Near-Term Approach; Duke-Margolis Has A Plan

Prevision Policy Clips | Pharmaceutical “Market Gaming Tactics” Will Be Focus of House Hearing Sept. 19

Prevision Policy Clips | It’s Not Over Yet: FDA Acting Commissioner Sharpless Scores Formal Interview with President Trump

FDA Mitochondrial Disease Workshop Has Division-Level Participation; Agency Committed To Getting To First Approvals In Ultra-Rare Disorders

Rare Disease Drug Developers Should Not Overlook Familiar Endpoints Relevant To Patient Burdens; FDA Is Not Wed To New Endpoints For Each Disease