FDA Draft Guidance Coming For Medication Assisted Treatments; MAT Policy Gets Prominent Plug From HHS - And Will Be Focus Of Patient Feedback Meeting In April

Prevision Policy Clips | Tissue Agnostic Therapies in Oncology: Regulatory Considerations for Orphan Drug Designation - Public Workshop

FTC Retrospective Study On PBM Mergers Urged By Former FTC Economist; Consolidation Anxiety On Capitol Hill Drawing In Drug Supply Chain

Prevision Policy Clips | Complex Innovative Designs in Clinical Trials FDA Meeting March 20

Prevision Policy Clips | CVS-Aetna Merger/Pharmaceutical Supply Chain Competition For Discussion at House Judiciary Committee Hearing February 27

Medicare Part D "Donut Hole" Discount In Budget Deal May Get Second Look, But Near-Term Fix Remains Unlikely

Prevision Policy Clips | 4/20 Wasn't Available? FDA Sets April 19 Date for GW Pharma Cannabinoid Advisory Committee

The Sarepta Precedent? PTC Ataluren Has A Path Forward – Good News For One Sponsor May Mean Trouble For Others

Prevision Policy Clips | PTC Says Accelerated Approval is An Option For DMD Treatment Ataluren

Part D Catastrophic Care Changes Are HHS Antidote To High Pharma List Prices, Azar Faces Tougher Price Questions In Senate And House On Feb. 15

FDA Early-Stage Alzheimer's Draft Guidance Re-Issued With New Flexibility On Clinical Trial Endpoints, Optimism On Biomarkers

Prevision Policy Clips | Novartis, Kite CAR-T Therapies Found to Align with Clinical Benefit According to ICER Report

CMS Predicts Diminishing Use Of Rebates And Drug Price Growth Will Drive Future Spending

FDA Plans Guidance On “Opioid-Sparing” Claims; Exparel Role Is Not Persuasive To Advisory Committee Without More Studies

FDA Has Its Say On Exparel: Split Vote By Advisory Committee Means Nerve Block Claim Likely Needs Another Study

FDA Issues Five Neurology-Specific Guidances; Characterizes Release As Part Of Bigger-Picture New Drug Reform Efforts

Prevision Policy Clips | Janssen’s Erleada Approval Sets Two Precedents: Novel Endpoint And First Sponsor To Agree To Data Sharing Pilot

CAR-T NTAPs Come to CMS: Yescarta, Kymriah Vie For Add-On Payments In B-Cell Lymphoma, Likely To Set High Mark For Drug NTAPs

Charleston's Hydexor Opioid/Anti-Emetic Combo Rejected By FDA Committee; Wrong Product For Current Climate

HHS Secretary Azar Emphasizes Biosimilars At House Ways & Means Committee

Prevision Policy Clips | Amgen’s Blincyto sBLA to Oncologic Drugs Advisory Committee March 7

Smooth ADUFA Reauthorization Process Expected; Animal Drug "Breakthrough" Designation Comes Up In Senate HELP Hearing

Prevision Policy Clips | Trump Budget - Part D Point of Sale Rebates Add $42 Bil. To 10-Year Government Costs; CMS Could Act Before Congress

Lilly Using Sentinel DMARD Clotting Incidence Data To Respond To FDA Premarket Safety Questions On Baricitinib; CBER Automating EHR Searches

Trump Budget: Part D Point of Sale Rebates Add $42 Bil. To 10-Year Government Costs; CMS Could Act Before Congress