Prevision Policy Clips | FDA Precision Dosing Meeting Aug. 12

Prevision Policy Clips | Bispecific Antibody Development Draft Guidance

Prevision Policy Clips | Acting Commissioner Sharpless “Not Planning Any Radical Changes” During Post-Gottlieb Era

Congressional Goals On Rebates Should Be Extending Reform To Commercial Market, Assuring Reductions Get To Patients, Pharma Execs Tell Sen. Wyden

Prevision Policy Clips | Achaogen Declares Bankruptcy, Puts Zemdri Up For Sale a Year After Approval

Real World Evidence And Gene Therapy: FDA Vaccine Studies On Duration-Of-Effect May Be Model

Prevision Policy Clips | Janssen’s Balversa Granted Accelerated Approval

Prevision Policy Clips | OMB Regulatory Review Policy Change Unlikely To Have Much Impact On FDA Or CMS

House Energy & Commerce Insulin Prices II: Bipartisan Interest To Get More Involved In Rebate Reform; Support HHS Or Take Issue Away?

Prevision Policy Clips | Part D Demo Removes “Unnecessary Risk Of Premium Hikes” If Rebate Rule Proceeds, HHS Secretary Azar Says

Prevision Policy Clips | Indivior Indictment Highlights Opioid Abuse, But FDA/“Evergreening” Issues Are A Key

Price Increase Cap Bill Clears House Committee: STAR Act Is Ways & Means’ Bipartisan Effort on Pricing – With Partisan Fights To Come

PBM Hearing Elicits Objections To HHS Rebate Rule, Ideas To Make January Start Possible; “Spread Pricing” Ban Coming Soon

Prevision Policy Clips | FDA “All-Hands” On Deck April 16: Acting Commissioner Ned Sharpless To Hold First Meeting

CBER Using Claims/EHR Database As Precursor To Reviews In Osteoarthritis, Sickle Cell, Diabetes: Shows How Sentinel Can Aid New Product Review

From “Gap” Discount To “Cap” Discount: MedPAC Proposal For New Part D Design To Lower Specialty Prices

Prevision Policy Clips | CMS Final Rule Implements BBA, Other Technical Changes In Part D

CMS Rebate Rule Clarification To Part D Plan Sponsors Allows HHS To Continue To Push Jan. 1 Effective Date – But Underscores Likely Delay

Prevision Policy Clips | Daiichi Sankyo Goes To ODAC; AML Drug With Breakthrough, Priority Review Delayed

CREATES, Pay-For-Delay Bills Head To House Floor; Democrats Concede On Some Republican Concerns

Prevision Policy Clips | REMS Guidance Finalized, Gottlieb Heads To AEI To Focus On Drug Pricing

Gottlieb’s Unfinished Business: Outgoing FDA Commissioner Cites “Complex” Generics, Fast Follow-On Innovator Competition As Still Needing Attention

Advisory Committee Tracker: Anti-Infectives Featured In Unusual Mix Of April Meeting Topics

House Insulin Hearing Tees Up Questions For Manufacturers Next Week; Bipartisan Approach By DeGette Offers Relatively Favorable Context For Testimony

Prevision Policy Clips | Cigna/Express Scripts Announces $25 Cap on Insulin Ahead of Pharma/PBM Insulin Hearing April 10