Prevision Policy Clips | Biopharma Congress Draft Agenda Now Available

Prevision Policy Clips | HHS to Appeal DTC Court Ruling

Biosimilars Reform Act? Senate Drug Pricing Bills Attempt To Improve The Pathway

FDA Pediatric Opioid Review Will Cover Post-Market Safety Of OxyContin, General Labeling Framework

Prevision Policy Clips | TherapeuticsMD Settles SEC Case Over FDA Disclosures

Prevision Policy Clips | Another Sarepta Controversy? FDA Rejects Golodirsen For DMD

Prevision Policy Clips | A Busy Week For August Approvals: FDA Clears Five NMEs Aug 12-16

“March-In” Is Out-Of-Step As Price Control Tool: Even Advocates For Pricing Actions See NIH Intervention As Impractical During NASEM Panel

Prevision Policy Clips | Who Needs Juul? GSK Consumer Nicotine Oral Spray OTC Application Will Be Reviewed

GAO PBM Report: Rebates Are 20% In Part D, PBMs Keep Very Little; Plan-Level Analysis Shows No Correlation Between Rebate Levels, Net Spending

Prevision Policy Clips | TB Alliance’s Pretomanid Approved Under LPAD Pathway

Prevision Policy Clips | GAO Report On PBMs Finds Rebates Represent 20% Of Part D Spending

The “Age Of Individualization”: Key Takeaways From FDA Meeting On Precision Dosing

HHS Pricing Advisor O’Brien To Depart; Medicare Principal Deputy Brooks Expands His Purview As Focus Shifts From “Blueprint” To Capitol Hill

Zolgensma Fallout: Grassley Letter May Mean More Headaches For Novartis; Democratic Inquiry Could Be Bigger Threat To FDA Climate Long Term

Prevision Policy Clips | HHS Senior Advisor Role On Drug Pricing Shifts To Medicare Principal Deputy John Brooks

Valuing Cures: ICER Proposes Framework For “Single or Short-Term Transformative Therapies” Including 12-Year Cut-Point For “Shared Savings”

Prevision Policy Clips | FDA’s Hylton Joffe, Tiffany Farchione, Steven Lemery and Bob Temple At The Biopharma Congress

The New OND: FDA Wants Input On “Opportunities And Priorities” For Office Of New Drugs Policy Development

Prevision Policy Clips | The New OND: FDA Wants Input On “Opportunities and Priorities” For The Office of New Drugs

Medicare CAR-T Coverage Will Follow Rx Oncology Model – Including Off-Label Use In Compendia; CMS Defers To FDA Rather Than Impose Stricter Limits

FDA Fabry Disease Draft Guidance Affirms Galafold Surrogate, But Not Other Potential Candidates; Seeks More Research On Three Possible Markers

Gilead Descovy PrEP Indication Headed To Approval; Use In Women Requires Further Data, But Might Make Label Anyway

Prevision Policy Clips | CAR-T Therapy Medicare Coverage Will Follow Typical Oncology Model

FDA Provider Survey Will Evaluate Perception of Boxed Warnings; Announcement Follows Advisory Committee Request For Information