From “Low-T” To “Low-S”? FDA Outlines Hypogonadism Pathway Focusing On Sperm Counts; PRO Process Needed?

Trump’s HHS Takes Shape: Price As Secretary, Verma To CMS; Emphasis On ACA Overhaul And CMS Reforms – Not FDA

NCI and FDA Oncology Workloads, Collaborative Ventures Could Provide Momentum To Protect Those Activities Under Trump

21st Century Cures Scorecard: Bill Poised For Enactment Drops Rx Incentives, But Keeps Most Key Drug Development Reforms

21st Century Cures: REGROW Changes Substantially In Favor of FDA Position To Make Bill A Lame-Duck Mover

Weekly Highlights: November 21-25

Manufacturing Quality Metrics Revised Draft Guidance Adopts a Voluntary Reporting Phase, Cuts Down to Three Primary Metrics

Oncology “Center of Excellence” Awaits Boost From “Cures”; New Model Consolidates Clinical Reviews Under Pazdur

“Repeal And Replace”: How Unwinding The ACA Might Work And The Uncertain Implications For Biopharma

FDA Lab-Developed Test Policy Dropped; Impact On Companion Diagnostics Likely Limited, And Smoother Path For User Fees

FDA and EU Oncology Drug Regulation: Patient Voice, Breakthrough/PRIME, Single-Arm Trials and Political Change

Cancer Trials: FDA Warming to Bayesian Approach To Early-Stage Studies With Large Effect Size; Push To Expand Eligibility

Weekly Highlights: November 14 -November 18

FDA Is “Moving Forward” After Exondys 51: Internal Disputes Are Settled, But Officials Urge Civility From External Stakeholders

National Academies’ Drug Affordability Project Kicks Off; Post-Election Changes Mean Longer Term Impact For Report

Off-Label Discussions By Marketers With Payors Have Growing Support; Post-Election Desire For More May Slow Progress

Medicaid Drug Spending Dashboard 2015: Almost Half of 20 Highest Price Increases For Generics

Weekly Highlights: November 7 -November 11

REVAMP-ing Antibiotic Incentives: “Wildcard” Patent Extension May Get Second Look In 2017

NME Approvals Will Be Down In 2016 But May Rebound In 2017; Manufacturing Deficiencies Leading To More Rejections

Biopharma And The Elections: Innovators Can Celebrate Big Victory On Pricing Policy; FDA Climate May Be Downside

FDA/CMS Collaboration: “Sleeper Group” Goes Public With Call For Shared Work On Real-World Evidence

FDA Office of New Drugs Fills Deputy Position From Outside; Merck’s Stein Brings Industry Experience In Endocrinology

Straight Talk On Drug Pricing: Why CMS Head Slavitt No Longer Defends Industry (Transcript From November 3)

Biopharma Congress Takeaways: Two Tales Of Innovation – FDA Under Strain, CMS Eager To Tackle Pricing With New Models