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Prevision Policy Clips | CBO Score of Pelosi Drug Pricing Bill By Mid-October
September 24, 2019
ICER Analysis Of Curative Therapies: Shared Savings Analysis Likely To Move Forward With Some Tweaks In November Final Report
September 23, 2019
FDA Wants Clinical Endpoints – Not Surrogates – In Alpha-1 Pre-Registration Studies, But Can Be Flexible On P-Values
September 23, 2019
Prevision Policy Clips | Amag Makena Accelerated Approval In Jeopardy? FDA Committee Will Discuss Failed Confirmatory Trial
September 23, 2019
Biosimilar Reimbursement Sweetener May Be Added To “Product-Hopping” Bill; House Hearing Features Testimony On Nuance Of Defining Anti-Competitive Conduct
September 20, 2019
House Part D Inflation Penalty Uses AMP, Rather Than Senate’s “WAC” Approach; HR3 Text Shows “Negotiation” Plan Is Even Worse Than It Sounds
September 20, 2019
“This Stuff Is Hard”: FOCR Real-World Evidence Collaboration Demonstrates The Promise – And Challenges – Ahead, FDA’s Abernethy Says
September 20, 2019
Prevision Policy Clips | Complex Innovative Trial Design Draft Guidance
September 20, 2019
House Unveils Rx Price Dictation Bill: Once-Unthinkable Policy Moves To Mainstream – But Big Difference Between Campaign Posture And Making Law
September 19, 2019
Beyond Price Negotiation: Key Items In House Bill Include $2,000 Out Of Pocket Cap In Part D, 10%/30% Mandatory Pharma Discounts
September 19, 2019
FDA Unveils Tech Revamp Championed By Deputy Commissioner Abernethy; Timelines Coincide With Key Funding Cycles
September 19, 2019
NDAC Recommends Approval Of GSK OTC Nicotine Spray With Trepidation Over Efficacy, Youth Abuse Potential
September 19, 2019
Prevision Policy Clips | House Drug Price Negotiation Bill: First Stop Will Be Energy & Commerce/Health Subcommittee
September 19, 2019
Pain Drug Developers Have List Of Incentive Requests For FDA, Congress; “Opioid-Sparing” Indication, “Breakthrough” Clarity Are Most Viable
September 18, 2019
FDA Opioid Framework: Agency Hears Calls To Re-Review All Marketed Products – And Consider Non-Opioid CNS Products As Well
September 18, 2019
Prevision Policy Clips | Senate Approps Full Committee To Meet September 19 To Consider FY2020 Ag/FDA Bill
September 18, 2019
Parallel Multi-National Review Becomes Reality At FDA With OCE-Led “Project Orbis” Approval Of Eisai’s Lenvima With Merck’s Keytruda
September 17, 2019
Prevision Policy Clips | Priority Review For Merck Ebola Vaccine
September 17, 2019
Regional/National Risk Pools For High Cost Therapies Get Support From Former FDA, CMS Officials Gottlieb and Conway
September 16, 2019
Biopharma Congress V
September 16, 2019
GSK OTC Nicotine Mouth Spray: Dark Clouds Around Vaping Should Help NDA Under Traditional Regulatory Model At FDA Panel
September 16, 2019
Aimmune’s Palforzia Peanut Allergy Therapy Clears Committee, Conditioned On REMS To Assure Supervision Of Dose-Escalation, Access To EpiPen
September 16, 2019
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
September 16, 2019
Expanded Access Concerns Continue Despite FDA’s Best Efforts: Firms Remain Wary Of Compassionate Use, Broader Clinical Trial Eligibility, GAO Finds
September 13, 2019
Medicaid “Best Price” Reforms To Enable Value-Based Contracts: Administrative Change Is Only Near-Term Approach; Duke-Margolis Has A Plan
September 13, 2019
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