Dynavax Heplisav B Vaccine Clears Safety Hurdle At FDA Advisory Committee; Stronger Post-Market Study Needed For Approval

Rx Competition: FTC Looking For “Test Case” On REMS Abuse But Wants Legislation; FDA Defending Unapproved Drugs Policy

IPC’s “Blue Dye” Oxycodone Headed for FDA Rejection; Agency Uses Committee To Continue Discussion of ADF Excipients

Dynavax Heplisav Vaccine Review Hinges On Potential CV Safety Signal: More Study Needed; Will It Be Pre- Or Post-Approval?

Intellipharmaceutics “Blue Dye” Oxycodone NDA Looks Out Of Step With ADF Policy; Committee Unlikely To Support Approval

Weekly Highlights: July 17-21

ICER Says Abuse-Deterrent Opioids are Not Cost Effective: Ratio Changes When Considering Diversion and/or Changing ADF Cost

FDA Working On Good Filing And Review Practices As Step To Speed Generic Approvals; “Name-and-Shame” For REMS Blocks Could Be Next

FDA Chief Counsel Wood Brings Labeling Litigation Experience –But Pre-Emption and Product Liability, Not Off-Label Promotion

340B Hearing: Bipartisan Support For Stronger HRSA Oversight –And Caution About Going Too Far

340B Payment Cut Proposed By CMS; Change Could Drive DSH Hospitals Out Of Program, But Double-Edged Sword For Pharma

Weekly Highlights: July 10-14

Herceptin Biosimilar Unanimously Supported by Committee; Manufacturing Issues Not Raised But Could Hold Up Approval

Amgen ABP 215 Biosimilar To Avastin Sails Through AdComm 17-0; Oncologists Okay With Extrapolation In Cancer

FDARA Hiccup? White House Is Not On Board With Generic Exclusivity Incentive; Revising Bill In Senate May Be Perilous

Off-Label Promotion Legislation Stalls Without FDARA – But New Leadership At FDA May Mean Wait For Clarity Ends Soon

Novartis Opens Up On CAR-T Processes To Win FDA Unanimous Committee Approval Vote; Opens Gate For Other Gene-Based Therapies

340B Oversight Begins: Whose Side Is HRSA On?

Mylotarg Ready To Return To Market: ODAC Endorses Event-Free Survival Endpoint But Wants Narrower Indication

Abuse-Deterrent Opioid Regulatory Changes Coming From FDA: Study Designs, Methods To Demonstrate “Real-World” Efficacy

Amgen ABP 215 Biosimilar To Avastin Goes To ODAC With Thorough Application; Sponsor Took Six Years From First Discussions With FDA

FDARA To House Floor: User Fee Bill Stays (Mostly) Clean; New Product Availability Reporting Requirement Added

FDA Opioid Policy Will Continue To Evolve: More Withdrawals, Labeling Changes Possible, Commissioner Gottlieb Says

Novartis CAR-T Review By FDA Committee To Focus More On Processes Than Clinical Results: Precedents For Gene Modification Era

Mylotarg Redux Tests Event-Free Survival Endpoint: Can it Be a Surrogate for – or Alternative to – OS in AML?