FDA Generates Broad Support For High Bar In Cellular and Regenerative Medicines: Workshop Trumps Open Hearing

Biosimilar Review Goals Will Harmonize With PDUFA In Reauthorization, But Fee Amounts Break Free

Weekly Highlights: September 12 - September 16

FAIR Drug Pricing Act: Another Sign That PDUFA VI Could Get Complicated

FDA Ad Com Splits on Box Warning on Pfizer’s Chantix; Support For More Access To Decrease Smoking Earns Narrow Majority

Spectrum Apaziquone Approval Awaits New Study Following ODAC Rejection; Low Bar For Efficacy – But Not Met Yet

Paying For Cures: System Needs Bigger Budgets And Longer-Term Outlook, Not Lower Drug Prices, Industry Execs Say

GAO Generics Part D Report Finds “Extraordinary” Price Increases For Low-Use Outliers In Face Of Falling Overall Prices

FDA Advisory Committee Unlikely to Support Removal of Neuropsychiatric Box Warning for Pfizer’s Chantix, GSK’s Zyban

Spectrum Apaziquone Appears Headed To Panel Rejection For Bladder Cancer; FDA Skeptical That Dose Timing Matters

Weekly Highlights: September 6 - September 9

Cancer “Moonshot” Report Recommends Investment In New Areas Of R&D, Clinical Trial Network; Theme Is Patient-Focused

FDA Cancels Dynavax Heplisav Panel Review; Is Another “Complete Response” Coming For Hep B Vaccine?

Opening A Broad Front In Fight Against Part B Demo: House Hearing Takes Aim At CBO and CMMI

OTC User Fee Update: FDA/Industry Negotiations Are Ongoing, But Market Exclusivity Is “Outside The Scope” Of Talks

Clinton Pricing Plan Aims To Eliminate The Turing Model, But Where Does It Draw The Line?

Weekly Highlights: August 29 - September 2

FDA and Biopharma in 2017: Regulatory Climate At Risk After Elections

Drug Discount Cards Bring Further Scrutiny To ASP As GAO Finds Widening Gap Compared To “Effective Market Price”

FDA Finally Sets Next Step In Off-Label Policy: Post-Election Hearing Agenda Acknowledges That New Approach Needed

Anti-Infectives Return To FDA Committee Agenda: Cempra Antibiotic Set For November; Dynavax Tries Again With Heplisav

FDA Finally Finalizes Registration and Listing Rule; Removes Requirement that FDA Develop NDCs

New Diabetes Endpoints: Hypoglycemia, PROs Tied To Continuous Glucose Monitoring Look Promising – Eventually

CMS Moves Fast To Reinforce Confidence In Exchanges; Rx Drug Data Risk-Adjustment Model Includes Hep C, MS, RA Therapies

Patient-Focused Drug Development for Big Diseases: Diabetes Meeting Offers Case Study; Important Opportunity For Sponsors