Biosimilars: Clinical Studies for Immunogenicity a Baseline Requirement, Phase 1 Data Alone Likely Inadequate

ANDA Refuse-to-Receive Guidances Aimed At Cleaning Up Filings As GDUFA Moves Forward

Slow-T? FDA Advisory Committee Supports Labeling Changes To Limit Testosterone Replacement Therapy Use

Part D More Efficient Than B? OIG Report Says Part B Overpays for Fees for Certain Drugs Compared to Other Programs

Clarus Oral Testosterone Therapy Faces Tough Panel Review: Bad Time For “Easier-To-Use” Options

FDA/NCI Cancer Signals Meeting Starts Process Towards Post-Approval Guidance; FDA’s Graham Discusses Current Projects

DEA Scheduling Reform Bill Clears House Panel, But With Longer Timeline To Review NMEs Before Launch

FDA Preparing Guidance on Ways to Display Ranges of Patient Responses In Labeling

NPS Natpara Clears Advisory Committee After Tough Debates; Dosing, REMS Issues Could Still Delay Approval

“Polypill” Advisory Committee Supports Use in Secondary Prevention; Questions on Populations and Post-Approval Studies

Novo’s Liraglutide Gets Solid Panel Approval Vote for Obesity: Postmarket Diabetes Experience, No Causal Cancer Carry Day

Abuse-Deterrent Opioid Formulation Guidance Will Be Focus Of Oct. 30-31 FDA Meeting

“FDA—Then and Now:” 10 Takeaways From UCSF Event On History and Future of Drug Regulation

Orexigen Contrave Approval Comes With Requirement For New CV Outcomes Trial; Confidentiality Still Issue For FDA

HHS Secretary Burwell Makes NIH/FDA Pitch At Energy & Commerce 21st Century Cures Initiative

CDER Compliance Head Schnedar Brings Ties To DoJ, Experience With Political Dimensions Of Investigations And Prosecutions

NPS Natpara: Rare Disease And Unmet Need Likely To Trump Questions About Efficacy, Cancer Risk at FDA Panel

Actavis Will Not Get Bystolic Line Extension: 6-4 “No” Vote Gives FDA Backing To Reject Nebivolol/Valsartan

Rx Abuse Stays In Spotlight Of Clinton Foundation; Proposal Focuses On Opioid Labeling, Naloxone Distribution

FDA’s “Purple Book” For Biologics Lists Teva’s tbo-filgrastim, Roche’s Perjeta as Reference Products with 12 Year Exclusivity

Lab Developed Test Policy Will Be Key Piece Of 2017 FDA User Fee Process; Biopharma Has A Stake Beyond Targeted Therapies

Novo’s Liraglutide For Weight Loss: Diabetes Experience Should Help Temper Pancreatitis and Cancer Risk Concerns

FDA Biomarker Workshop: PDUFA VI Support For Qualification Staff, “Breakthrough” For Diagnostics Among Next Steps

FDA Preview of CV “Polypill” Pits Public Health Goals Against Advantages Of Individualized Therapy

Actavis Bystolic Combo Faces Cutback In Doses, Indications: FDA Committee Discussion Will Not Help Commercial Prospects