Opioid REMS Review: Restricted Distribution For All Opioids Will Be Topic For Discussion; Another Push For Legislative Changes?

Hospital/Insurance Coalition Releases Drug Pricing Proposals; Health Stakeholders Argue For Transparency Parity

Sarepta’s Eteplirsen for DMD: Split Vote Should Assure Rejection Of NDA, But Accelerated Approval Could Still Be Near Term Option

Organ Transplant Patient-Focused Drug Development Meeting Scheduled for September 27; Likely Focus on Immunosuppressants

Weekly Highlights: April 18-22

CMS Reviewing BI, Jazz, Portola and BTG Drugs for Add-On Payments; Amgen’s Blincyto NTAP to Continue in FY2017

House Bill To Codify FDA Opioid Action Plan Among 12 Addiction Bills Moving To E&C Committee Mark-Up Next Week

Sarepta’s Eteplirsen For DMD: It’s All Over But The Shouting

Regulating Cell Therapies: Conditional Approval Pathway Under Consideration In Senate; FDA Plans Public Hearing In September

FDA Data Integrity cGMP Guidance Addresses Paper, Electronic Records Handling and Auditing As Violations Have increased

Weekly Highlights: April 11-15

Galderma’s Differin OTC Switch Clears Committee: Advice Split On Pregnancy Label For “Precedent-Setting” Acne Application

FDA Withdraws Indications for AbbVie’s Niacin and Fenofibric Acid Use With Statins: Implications for Cholesterol Space

Master Protocols, Next-Gen Manufacturing Will Shorten Time To Approval, CDER Director Woodcock Says

“Breakthrough” At 40: Program Hits Milestone Approval; Quality Of Requests Improving, But “Gray Zones” Persist

FDA Appropriations Bill Tries Backdoor To “Cures”: Three Consensus Provisions Included – But Without New Funding

Galderma’s Differin Acne Gel OTC Switch Looks Doubtful: Retin-A Precedent and Consumer Studies Bode Poorly; No Help From “NSURE”

Clovis Needs Another Completed Clinical Trial For Rociletinib NDA: Comparisons To Tagrisso Make For Tough FDA Committee

Patient-Focused Reimbursement Development? Move To Value-Based Pricing In Part B Will Rely On Patient Input, CMS Says

Weekly Highlights: April 4-8

Clovis Rociletinib: FDA Pushing For Third Study Prior To Approval; Two TIGERS Not Enough

CDER Brand Name Reviews: 86% Of Proposed Proprietary Names Granted By Agency; Predictability Returns To Process

Intercept’s OCA for PBC: FDA Surrogate Validation On The Fly Leads To Unanimous Panel Vote for Approval

NIH Explains Reluctance To “March In”: Collins Suggests Authority Not Intended To Address Pricing Concerns

Final “Cures” Bill Takes Shape: Senate Committee Reports Five Sections; Pledge to Find NIH Funding On Floor—But No Timeline