Optimer’s Dificid Gets Unanimous Approval Vote from FDA Committee: Company Will Not Be Able To Claim Clear Effect on C. Difficile “Recurrence”

Optimer Dificid (Fidaxomicin) Appears Headed to a Not Difficult FDA Advisory Committee

KV Makena Effective Medicaid Price to Start at $530

CMS Weighs in on KV’s Makena: Medicaid Can Pay for Compounded Product

KV’s Makena: FDA Says It Will Look the Other Way on Pharmacy Compounders

Advisory Committee Tracker: Meetings Down in First Quarter; Trend for Year?

Novartis Arcapta US NDA Review Action Date Pushed To July 1

KV Makena Price Attacked On All Fronts: Headlines Give Payors Greater Leverage, But Policy Action Unlikely

Merck Goes First to FDA Hep C Advisory Committee; Vertex Review Will Occur In Penumbra of Boceprevir

Drug Review Dossier: vismodegib

JNJ OTC Consent Decree Could Have Been Much Worse

Novartis Wins “Yes” Vote for Arcapta (Indacaterol) 75 mcg; Loses Ground on COPD Strategy

ACOs and Biopharma: Opportunities and Challenges Under and Integrated Provider Model

Novartis Arcapta COPD Once Daily Inhaler: Key FDA Question Is Whether Dose is Low Enough

Drug Review Dossier: Xarelto for AFib

Celgene Off-Label Investigation in Context

Advisory Committee Tracker: All Eyes on ODAC

FDA Releases Draft Guidance on MedGuides; Addresses Distribution and Inclusion in REMS

Avastin FDA Hearing Set for Late June; Genentech Faces Near Impossible Task but Gains Another Six Months

FDA in a Government Shutdown: Unchartered Territory for New Drug Reviews

Biologics Exclusivity Cut Called for in President’s Budget: All Bark, No Bite

Oncology Accelerated Approval: FDA Details AA Pathway Performance and Looks For Refinements

Oncology Accelerated Approval Briefing Documents Reaffirm Meeting Purpose: Standard Updates from Sponsors; AA System Improvements

Future of Contrave in Peril Following FDA’s Complete Response Letter

Weight Loss Drugs a Year Later: Still No Clear Path to Approval, but Don’t Count Out Vivus’ Qnexa