GSK Nucala Severe Asthma Biologic Approval For Adults On Track; FDA Shows Interest In Label Impact On Other Biologics

“Breakthrough” Manufacturing: Is PDUFA VI A Chance To Move Past Quality As Rate-Limiting Step?

340B Reform Legislation: “Cures” Ship Has Sailed, But Bipartisan Work Continues In House

Amgen’s Repatha On Repeat: Panel Recommends Approval In HoFH and High Risk Patients; LDL As Surrogate Debate Softens

FDA DMD Guidance: Dystrophin Justifies “Particular Interest” For AA; Function Endpoints Urged For Wide Range of Deficits

GSK Injectable Severe Asthma Product, Nucala, Appears Headed For Adult OK From FDA AdCom; Blood Test Debate

Sanofi/Regeneron Praluent Wins Support From FDA Committee, But Label May Be Narrow; LDL Controversy Not Going Away Yet

FDA “Approves” Amarin Vascepa Off-Label Campaign; Letter Previews Upcoming Communication Guidance

Generic Drug Surveillance, Excipient Research Are Key Issues for Acting OGD Director Peters: GDUFA Reg Science Meeting

Amgen’s Repatha: Second PCSK9 Panel Review May Be Less Smooth, But Positive Outcome Nonetheless

Sanofi/Regeneron Praluent: FDA Review Is Positive, Especially On Safety; Panel Asked To Reaffirm LDL-C As Endpoint

Sprout’s Flibanserin Approval from FDA Committees Comes with Support for Label Warnings, Restrictive REMS

FDA “Do-Not-Compound” List: Agency Proposes Six Criteria To Kick-Off Process; Avastin Unlikely to Be Included

Tentative FDA Arthritis Advisory Committee Added In October; No Update On Infliximab Biosimilar Ahead Of June 8 Action Date

White House Antibiotic Forum Focuses On Stewardship: Food Supply, Not Rx, Focus For Government Actions

Sprout Female Sexual Dysfunction Drug Flibanserin Gets Past Efficacy Issues; Safety With Alcohol Is Key For June 4 Committee

Medicaid Managed Care and Biopharma: 45-Day Drug Utilization Reports In Focus, 340B Discount “Double Dip” Liability On MCOs

Testing Abuse Deterrent Formulations: FDA Committees To Review OxyContin Studies for “Meaningful Impact” on Abuse

Biopharma Policy 2015 “Graduates”: Energy & Commerce Round of Thanks for “21st Century Cures Class of 2015”

Advisory Committee Tracker: Sanofi/Regeneron, Amgen Cholesterol Drugs Highlight June Meetings

FDA Plans Updated “Fixed-Combination” Rule To Clarify Circumstances For Waiver To Comparative Requirements

Hatch/Klobuchar Introduce Orphan Exclusivity Bill in Senate To Bring House “Cures” Incentive Into Play

House Opioid Hearing Highlights State Requirements for Prescriber Education, PDMP Participation

“Breakthrough” Dose-Finding In Oncology: Enrollment A Plus, Speed To Commercialize An Impediment

Antibiotic Price Support Through Medicare Included In 21st Century Cures Bill Reported Out Of Committee