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FDA Fabry Disease Draft Guidance Affirms Galafold Surrogate, But Not Other Potential Candidates; Seeks More Research On Three Possible Markers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

Zolgensma “Data Manipulation Issue” Disclosed By FDA: Blemish On Landmark Approval For Now; Full Implications May Not Be Clear For Months

Prevision Policy Clips | Zolgensma “Data Manipulation Issue” Disclosed By FDA: Blemish On Landmark Approval – But May Be “Months” Before Full Impact

Oligonucleotide Therapeutics Docket: FDA Seeks Input On Clinical Pharmacology And Whether Findings Can Be Applied Across A Sponsor’s Products

Prevision Policy Clips | FDA Seeks Input on Oligonucleotide Clinical Pharmacology

QIDP Gets NTAP Boost: CMS Enhances Payment For Hospital-Administered Novel Antibiotics To 75% In HIPPS Final Rule; Other Products Increase to 65%

Gilead’s Descovy Headed For Positive Advisory Committee For PrEP, Likely Without Indication For Cisgender Women Or Safety Advantage Over Truvada

Prevision Policy Clips | CMS Approves 8 of 8 Drug NTAP Applications For Fiscal 2020– Venclexta Application Withdrawn

Part B Inflation Penalty: Minor Impact On Major Brands – But End Of One Venue For “Re-Pricing” Actions

Prevision Policy Clips | Merck Ebola Vaccine Appears to Increase Survival, NIAID Director Says

Exondys 51 Has “Inadequate Evidence” Of Net Health Benefits Over Steroids For Duchenne, ICER Panel Says; Emflaza Fairs Better In Review

Prevision Policy Clips | NDA User Fee Increases To $2.94 Mil. For Fiscal 2020

FDA Heart Failure Endpoint Meeting: Effort To Encourage Drug Development Illustrates Challenges For Sponsors

Rare Pediatric Disease PRVs: Voucher Eligibility Depends On Showing “Serious Manifestations” In Children, FDA Draft Guidance Explains