Breast Cancer Patients Call For More Personalized Analyses of Treatment Options, Fatigue PRO Refinement

Patient-Reported Outcomes Tool for Crohn’s In Development; FDA Interested in More Qualification Data

FDA Clinical Outcomes Assessment Workshop: Web List Featured; Review Divisions More Active In PROs

PDUFA V “Program” Review Builds The Case For More User Fees; High “First-Cycle” Approval Rate Gets Higher

FDA Final Abuse-Deterrent Opioid Guidance Eliminates “Tiers”, But Retains Tiered Approach; “Real World” Claim Is High Bar

Biosimilar Commercialization: Patent Exchange Dispute Offers Some Clarity; CMS Readies For Launch With Pro-Biosimilar Policies

Medicare “Doc Fix” Enactment Looks Good For Biopharma: Part D Rebate Threat Recedes, Sequester Repeal More Likely

Advisory Committee Tracker: Cangrelor Indication Change Is Ominous Sign In Return To Panel; Vertex CF Review Set For May

FDA Hearing On Generic Labeling: Brand/Generic Industry EAR Proposal Puts FDA In Middle; Patients Support FDA Proposal

FDA Commissioner Hamburg’s Farewell Address: Defense Of Approval Standard Framed As Rebuttal To Alzheimer Advocates

White House Antibiotic Report Supports Push Incentives Over Pull; “Wild Card” Patent, Other Prizes Not Included

Specialty Tier Cost-Sharing Bill Would Limit Beneficiary Co-Pays for Specialty Drugs to Same Level of “Non-Preferred Brand” Tier

Pediatric Stakeholders Want Fewer Orphan Exemptions, More Work in Pediatric Cancer; Califf Makes Debut as FDA Deputy

Buprenorphine Use Attacked During House Hearing On Opioids; HHS Initiative On Rx Abuse Offers Tepid Endorsement

King v. Burwell Outlook: Oral Arguments Recalibrate Expectations For Potential Outcomes; Worst-Case Scenario Would Allow Time For Fix

PD-1 Lung Cancer Drugs Pose Companion Diagnostics Dilemma; FDA, Industry Discussing Post-Market Harmonization Strategies

MEDCAC Has ‘Low Confidence’ in Prognostic Value of Molecular Pathology Testing in Most Cancers; CED May Be Route Forward

Senate’s Second Hearing On Advancing Research: Limited Population Approvals Tops Short List; April 28 Is Next Hearing

House 340B Hearing: Bipartisan Interest In Enhancing HRSA Authority, Tracking Use Of Savings; No Sign Of Major Rollback

DMD Dystrophin Workshop Features Early-Stage Challenges With Sponsors At The Late-Stages Of The Regulatory Process

GSK’s Breo Ellipta For Asthma Gets Recommendation In Adults With Postmarket Safety Trial; Pediatric Indication Rejected

CDER Safety Research Needs Report May Foreshadow User Fee Negotiation Topics; Sentinel Methodology One Item To Watch

GSK’s Breo Ellipta for Asthma: Review To Focus On Safety But FDA Appears Favorably Inclined; Pediatric Indication At Risk

FDA/DEA Scheduling Bill Clears House; Favorable CBO Score Eases Path To Enactment

Orexigen LIGHT Study Disclosure Underscores FDA Concerns About Interim Data; Big Pharma May Fare Better Than Small