Biologics Naming: FDA Drops Plan To Force Innovators To Add Suffix – But Decides To Keep “Nonsense” Modifier For Interchangeables

Prevision Policy Clips | Naming Policy For Marketed Biologics: No Suffixes Needed

Next FDA Commissioner: Current HHS Official Seems Likely Choice, But Faces Tall Order To Match Gottlieb’s Activist Profile And Insider Knowledge

Prevision Policy Clips | FDA Succession: NCI’s Sharpless, HHS’ Giroir Among Potential Commissioner Candidates

FDA Commissioner Gottlieb To Leave Agency In Coming Weeks; Departure Feels More Abrupt Than It Is – But Underscores Risks To FDA Climate Ahead

Measles Hearings Offer Counterpoints To Drug Pricing Themes: Importance Of MMR, Other Vaccines Stressed, National Education Effort Encouraged

FDA Commissioner Gottlieb Leaving Agency This Spring

CDER Planning Guidances for ADHD, Gastroparesis, Heart Failure and Opioid Benefit-Risk Assessment Framework for 2019; Replacements On Non-Opioid Analgesic Development Not Listed on Agenda

ICER Uses New Models For SMA Review: FDA Patient Input Cited In Report Ahead Of Challenging Policy Discussion At Upcoming Meeting

Prevision Policy Clips | Purdue Exploring Bankruptcy Amid Lawsuits

Commissioner Gottlieb’s First Appearance Before Democratic House: Less Praise For FDA, But Also No Invective

Proposals And Promises: What Pharma CEOs Brought To The Senate Finance Hearing On Drug Prices – And What Was Left Unsaid

Sanofi Dengue Vaccine Candidate: FDA Review Suggests Support For Narrow Approval (And Voucher) – But Will Committee Want To Wait For Other Options?

Advisory Committee Tracker: Post-Shutdown Scheduling Lull Continues; Sanofi Dengue Vaccine Is Main Event For March

Prevision Policy Clips | Lilly To Launch Humalog Authorized Generic At Half The List Price

Bipartisan Think-Tank Drug Pricing Agenda: Finalize “Protected Class” Rule, Pursue Competitive Bidding In Part B – But Not IPI

Prevision Policy Clips | Part D Annual Update Rule Sent To OMB Feb. 28

OCE Deputy Is Blumenthal As FDA Loses One Pazdur Protege McKee; Broad Oncology Team Has Deep Talent

Prevision Policy Clips | Senate Aging Takes on Drug Pricing in Back-to-Back Hearings

Senate Finance Committee Is Relatively Benign Forum For Pharma CEOs; Wyden’s Caustic Intro, Hassan On Opioid Marketing Are Sharpest Criticisms

FDA Post-Shutdown Update: Inspection Goals Reduced, Review Dates Safe; Will Morale Hold Up?

ODAC Favors Delay For Karyopharm’s Selinexor Until FDA Receives Randomized Trial Results; OCE’s Pazdur Says Single-Agent Activity “Missing”

Legislated Protection For Value-Based Agreements Getting Positive Attention In Bad Climate; Pharma Witnesses Support PAVE At Senate Hearing

FDA’s 2019 Opioid Agenda Includes Mandating Post-Market Efficacy Studies; Work on Short-Duration Packaging Planned for First Half of the Year

Pharma CEOs Voice Support For CREATES Act At Senate Finance Hearing; Humira Patent Thicket Draws Criticism From Both Sides Of The Dais