Ferring Appeals Two Desmopressin FDA Rejections At Jan. 12 Committee; PRO Process Is Instructive Lesson

“Historic” Biosimilar Advisory Committee Meeting Shows Strength Of Novartis Filgrastim Data Package, Steep Learning Curve For All

FDA Overview 2015: Key Issues and Events To Watch

Novartis’ Neupogen Biosimilar: FDA Says It Has Met The Bar; Indications Likely To Be Extrapolated But Still No Naming Decision

Neurology Next? CNS Could Be Candidate For Antibiotic-Like Revival At FDA; IoM Event May Tee Up Themes

Advisory Committee Tracker: First Biosimilar Review Set For January; More To Come In 2015

Track and Trace: FDA Won’t Enforce New Rx Tracing Requirements Until May 1

FDA Sticks To Its Orphan Drug Designation Policies; Gralise Exclusivity Ruling Will Apply Only To That Drug, FDA Says

Payors Demand Dialogue On Pricing, But May Be Talking At Cross Purposes With Pharma; CMS Not A Threat

Advisory Committee Trends: Panels Voted “Yes” 60% of the Time in 2014, 71% for New Molecular Entities

E-labeling Proposed Rule Eliminates Paper Prescribing Information in Most Cases in Favor of FDA Online Repository

Regulatory Outlook Bright For Biopharma, But FDA Hiring Challenges Could Start To Threaten Review Efficiency

FDA One Step Closer To “Do-Not-Compound” List: Names Members of Pharmacy Compounding Advisory Committee

Senate “21st Century Cures” Response Continues With “Dormant Therapies Act”; Version of MODDERN Cures 15-year Exclusivity

Omnibus Appropriations Bill Includes Opioid Rider: June Deadline For Abuse-Deterrent Guidance

PATH To New Approval Pathway? Senate Limited Population Antibiotic Bill Allows Expansion Into Other Therapeutic Areas

FDA Funding Increase Will Be $137 Million For FY 2015; Ebola Funds Help Assure Stability On Discretional Spending

FDA “Authorized” Distributor Registry Will Include Third-Party Logistics Providers As Well As Wholesalers

Part D Program Integrity Tools That CMS Does Not Want: One, At Least, Needs Congressional Action

First Biosimilar Advisory Committee Scheduled for Sandoz’ Neupogen Biosimilar; Notice Gives No Clue On Naming Issue

Actavis Antibiotic Gets Two Approval Votes; Committee Less Willing Than FDA To Extrapolate To Gram Negative Infections

Generic REMS Guidance From FDA: Agency’s Desire To Break Brand Protections Is Real, Power Is Limited

FDA Takes Antibiotic “Unmet Need” Pathway to Advisory Committee In Advance of Final Guidance

CMS Shifts To Survival Mode With ACOs Regulation, Introduces New Increased Shared Risk Model; Low Impact On Drug Industry

Actavis/Cerexa Antibiotic Heads To Committee With FDA Agreement On Shortened Pathway But Potential Labeling Issues