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

Aimmune Palforzia Peanut Allergy Therapy: FDA Review Suggests Straight-Forward Benefit/Risk Tradeoff In Favor Of “Breakthrough” Product

Prevision Policy Clips | Amarin Advisory Committee Confirmed

House Dems Disavowed Drug Pricing Draft Sets One Extreme For Debate; Still A Path To Compromise With Senate

Prevision Policy Clips | No Advisory Committee for Lumateperone?

Prevision Policy Clips | Sen. Durbin Calls On FDA’s Sharpless To End Vaping Or Resign; 10-Day Deadline

Prevision Policy Clips | FDA Commissioner Hahn? MD Anderson Radiation Oncologist Now Tabbed As “Front Runner”

FDA’s Unusual Commissioner Transition Continues: Formal Nomination Likely Coming Soon – But It May Not Be Sharpless

Prevision Policy Clips | GBT Sickle Cell Therapy: FDA Accepts Application And Says No Advisory Committee Planned

MD Anderson Oncologist Stephen Hahn Emerges In FDA Commissioner Search