Prevision Policy Clips | Obesity Drug Coverage Rule Blasted By RFK Jr. Advisor Calley Means

The Politics And Policy Of Weight Loss Drug Coverage: CMS Coverage Proposal Will Test Incoming Trump Team; Is “Obesity” A Disease?

Prevision Policy Clips | CMS Weight Loss Coverage Rule Will Pose Early Test For Incoming Trump Administration

Atara/Fabre Tab-Cel Will Test Value Proposition For Allogenic Therapies: ICER Suggests $200,000 Per Cycle Could Be Cost-Effective; Payors See Coverage As “Relatively Straightforward”

Prevision Policy Clips | Hostile Takeover Of FDA? Commissioner Pick Martin Makary

FDA Commissioner Pick Makary Has Strong Views On Agency But Little First-Hand Knowledge; Has Criticized FDA Decision-Making And Work Ethic Around COVID

AZ Andexxa “Full” Approval Unlikely After FDA Committee Questions Confirmatory Trial Benefit; Accelerated Approval Status Seems Secure

OTCs At FDA: OMUFA II Will Show “True Promise” Of Monograph Reform; “Infrastructure” In Place Four Years Into New Program, “Innovation” Should Follow

Prevision Policy Clips | IPR Patent Board Reform Bill Advances In Senate, But Floor Vote Depends

The “DOGE” Manifesto: Regulatory Rollback May Not Affect FDA Much Beyond LDTs; End Of Telework Could Be Tougher On Agency

Clozapine REMS Appears Headed for Removal: FDA Advisory Committee Says Blood Monitoring Documentation And Provider Education Requirements Are Not Necessary To Ensure Safe Use

Prevision Policy Clips | CMS “Is Stronger Than Ever” As Biden Administration Draws To A Close

We’re Not In Kansas Anymore: CMS Nominee Oz Brings Unpredictability To Medicare Program; Round 2 Of Drug Price Negotiations Will Be Early Anti-Corporate Test

Prevision Policy Clips | Trump Embraces Telehealth? TV’s “Dr. Oz” Is Choice For CMS Administrator

FDA Caught Between Kennedy And Conservative Courts: Three Thorny Issues Will Test Agency’s Ability To Face Institutionalized Second-Guessing In 2025 And Beyond

AZ Andexxa Confirmatory Trial Questioned By FDA: AdComm To Discuss Thrombosis Risk, Lack Of Long-Term Benefit; Additional Trial May Be Next Step

Prevision Policy Clips | FDA Commissioner Speculation: Ohio Republican Rep. Wenstrup Said To Be Interested

FDA’s Gene Therapy Primer: FAQ Draft Guidance Addresses Common Questions For Cell/Gene Therapy Development; Fulfills PDUFA Commitment

FDA Sentinel Safety System Adjusting To “Hard Truths” Of Budget Uncertainty; Focus Will Be Operations, Not New Initiatives, Going Forward

Lilly Product Reclassification Campaign Expands To siRNA; FDA “Biologics” Definition Could Be Key Theme In 2025

Prevision Policy Clips | Gene Therapy FAQs: FDA Releases Draft Guidance

Clozapine REMS Review: FDA Committee Will Decide If Program Can Be Pared Back – Or Eliminated – Given Experience During Decade Of “Enforcement Discretion”

Prevision Policy Clips | Through The Looking Glass: RFK Jr. Is Trump’s Pick For HHS Secretary

Through The Looking Glass: RFK Jr. Is Trump’s HHS Pick

Oligonucleotide Nonclinical Safety Assessments: FDA Draft Guidance Addresses “Unique Challenges” With Category, Including Risk Of Off-Target Binding