Prevision Policy Clips | Novo Wegovy, Saxenda Weight Loss Cost-Effectiveness Questioned By ICER

Prevision Policy Clips | Novavax COVID Vaccine “One Step Closer” To US Market: 3.2 Million Dose Purchase Agreement

Prevision Policy Clips | Pfizer/BioNTech Comirnaty Expands Fully Approved Indication To Include 12-15 Year Olds

Senate Bill Ups Price Negotiation Savings Estimate In CBO Analysis; Overall Package Scores At $288 Billion In 10-Year Savings – And $166 Billion Without Counting “Rebate Rule”

Part B Wastage “Refund” Invoices Will Be Sent To Manufacturers October 1, 2023; Modest Impact On A Handful Of Products

Prevision Policy Clips | Part B Wastage “Refund” Bills Will Be Sent To Manufacturers Oct. 1, 2023

USPTO Embraces Collaboration With FDA On Training Of Patent Examiners But Seems Eager To Go Further, Including Ferreting Out “Inconsistent” Statements

Prevision Policy Clips | Coherus/Junshi's Toripalimab Resubmitted; China-Only Pivotal Trial Appears Acceptable

Senate Drug Pricing Language Sticks To House Blueprint; Minor Tweaks Include New Biosimilar Protections And Expanded Part D Subsidies

Prevision Policy Clips | Senate Drug Pricing Provisions Unveiled: “Negotiation,” Inflation Penalties, Part D Overhaul

Advisory Committee Tracker: Amylyx ALS Drug AMX0035 Gets A Second Chance; Is FDA Applying Lessons Learned From Aduhelm?

PFDD Public Meeting Features Products, Indications Supported By Guidances “1 and 2”; FDA Reviewer Says Dupixent EoE Approval Not Possible Without PFDD Guidances

Patient-Focused Clinical Outcome Assessments Are Not “PRO-Centric,” FDA Says; PFDD Guidance On Selecting COAs Is Designed To Extend Options

Prevision Policy Clips | FDA Updates Track And Trace Draft Guidances Ahead Of November 2023 Deadline

Prevision Policy Clips | COVID Booster For Fall Will Be Bivalent With Omicron BA.4/5 Component, FDA Confirms

Prevision Policy Clips | Zelnorm Withdrawn Again - This Time for Business Reasons

FDA Was Making Progress On Foreign Inspections Pre-COVID, OIG Finds; “Hybrid Inspection” Pilot Program Complements Agency Self-Improvement

Omicron-Variant COVID Boosters Endorsed By FDA Advisory Committee: FDA Will Likely Seek Bivalent Booster With Current Strain Plus BA.4/5 Variant

Prevision Policy Clips | PFDD Clinical Outcome Assessment Draft Guidance From FDA

Continuous Manufacturing Submissions Achieve FDA Approval Nine Months Ahead Of Batch Manufacturing, FDA Analysis Finds

Bluebird’s Beti-cel Reduction Of Patient Treatment Burden Sways ICER Panel; Sets Stage For Next Gene Therapies To Supplant Current Treatment Regimens

Oligonucleotide Development: FDA Clinical Pharmacology Guidance Emphasizes Liver And Kidney Function Impact

Prevision Policy Clips | CMS “Enhancing Oncology Model” Narrows Focus Of Existing Medicare Oncology Management Pilot To Seven Cancers

FDA External Controls Guidance Will Not Be “One-Size-Fits-All”; Agency Reviewing And Incorporating “Thousands” Of Comments To Initial RWE Guidance Set

OTC “Safe Use” Pathway Emerges At Last: FDA Proposal Has New Acronym – “ACNU,” Not “NSURE”; Commercial Landscape Has Changed Dramatically Since Idea First Floated