Prevision Policy Clips | CBO Study Of Comparative Drug Prices To Federal Programs Prepared For Senate Budget Committee

Medicare “Payment Streams” For Gene/Cell Therapies: Innovation Fund, NTAPs-Plus, And Medicare Advantage Offer Reimbursement Pathways

Prevision Policy Clips | A New Beginning? Biden Visit To Pfizer COVID Vaccine Plant In Michigan

ICER Panel Finds Inadequate Evidence to Demonstrate Net Health Benefit of AZ’s Roxadustat for CKD Anemia; Meeting Comes Before FDA Approval, May Require a Follow Up

Oncology Immunotherapy Safety: Harmonized Data Collection Would Better Track CRS Risk, Friends Of Cancer Research Working Group Says

Prevision Policy Clips | FDA Defends Drug Development Collaboration With Sponsors In Response To Public Citizen Aducanumab Letter

CAR-T Manufacturing Changes: FDA Drafting Policy To Streamline Process, Wants To Avoid Stifling Innovation

Prevision Policy Clips | HHS Nominee Becerra Will Go Before Senate HELP Committee Feb. 23

FDA Analysis Of Refuse-To-File Letters: About 4% Of NDAs Get One; More Than A Third Are Ultimately Approved After Average Two-Year Delay

Prevision Policy Clips | Diabetes Cell Therapy Goes To Committee: CellTrans’ Donislecel Will Be Reviewed

Prevision Policy Clips | Pfizer/Lilly Anti-NGF Pain Therapy Tanezumab Set For Advisory Committee Review March 24-25

ICER Panel Finds Roles For Bempedoic Acid, Inclisiran In High Cholesterol Subpopulations; PCSK9 Experience Cited As Setting Positive Pricing Benchmarks

Prevision Policy Clips | FDA’s Office of Generic Drugs Approved Or Tentatively Approved 72 First Generics In 2020

ODAC Votes To Delay Decision On Keytruda For Triple Negative Breast Cancer; Cautious Optimism For Better Data In Next Interim Analysis

Medicaid Rebate Cap Would Be Lifted In House COVID Relief Bill; FDA Set For $500 Million In New Funding

Prevision Policy Clips | Medicaid Rebate Cap Would Be Removed In House COVID Relief Bill

Slow Pace Of COVID Therapeutics Compared To Vaccines Could Become Issue For FDA With Congress; Infectious Disease Clinical Trials Network Urged

Prevision Policy Clips | FDA Office Of New Drug Policy Acting Director Is Maarika Kimbrell; Keith Flanagan Leaves

Prevision Policy Clips | Inspection-Related And Controlled Correspondence Proposals Emerging In GDUFA Negotiations

Merck Unlikely To Secure Triple Negative Breast Cancer Indication For Keytruda; FDA Sees “Small” Effect In Interim Data; Challenging ODAC Ahead

OCE “Project Post COVIDity” Will Track COVID Impacts On Cancer Patients Using “Real World” Data – Oncology Center Annual Report

Prevision Policy Clips | J&J COVID Vaccine Candidate Advisory Committee Review Set For Feb. 26

Prevision Policy Clips | FDA Warns Of Increased Risk Of Heart-Related Problems, Cancer With Pfizer’s Xeljanz Based On Post-Marketing Study Results

FDA Urged To Play Greater Role In Identifying Supply Chain Vulnerabilities And Supporting VA/DoD Domestic Purchasing; GAO Report Goes Beyond CARES

FDA Inspection Data In GAO Report Shows Huge Catch-Up Effort Ahead; Agency Urged To Plan Now For Post-COVID Backlog