FDA/BioPharma Fall Preview: Big Safety Decisions Pending; Industry Negotiations Set the Table for Key Legislation in 2011-2012

Boehringer-Ingelheim Pradaxa Atrial Fib Drug Headed To Sept. 20 FDA Advisory Committee with FDA Blessing for Approval But Not Superiority over Warfarin

Arena’s Lorcaserin Advisory Committee: Mid-Day Update

Arena’s Lorqess: Advisory Committee Rejection May Be Worse Than It Sounded, But Path Forward Remains

Vivitrol Vote Memo

Alkermes Vivitrol Opioid Indication: One Russian Study May Suffice for Supplemental NDA

Abbott’s Meridia: Split Vote From Committee Underscores Work Ahead on Risk Management for Weight Loss

Arena’s Lorqess: FDA Review Documents Are Very Tough; Focus Should Shift to Defining Path Forward for Weight Loss Drug in 2011

Meridia Safety Review: FDA Documents Emphasize Patterns of Real World Use; Important Themes for Arena and Orexigen

Forest Pulls Daily Double: Gets Two Unanimous Positive Recommendations for New Cephalosporin (Ceftaroline)

Advisory Committee Best Practices (Download PDF)

Forest Ceftaroline Pneumonia Efficacy: Unanimous Approval Recommendation; Concern About Use Against MRSA Pathogens

PDUFA V Negotiations Begin in Earnest: The Roadmap Towards 2012 Legislation

Forest Ceftaroline: Looks Solid for Broad Pneumonia, Skin Infection Indications

Advisory Committee Tracker: Filling in the Blanks for the Rest of 2010

FDA Advisory Committees in 2010: They Really Are A Coin Flip

Jazz Pharmaceuticals’ Rekinla: Expanded Indication Rejected By Committee

Jazz Pharmaceuticals Rekinla: Risk Management At The Heart Of FDA Analysis, Not Approvability

Abbott’s Meridia and Arena’s Lorqess Are Next Up for FDA Endocrinologic & Metabolic Drugs Advisory Committee: Expect Another Safety Echo-Effect on a New Obesity Agent From Meridia Discussion

Advisory Committee Tracker: A Quiet(er) August

Opioid REMS: Advisory Committee Rejects FDA’s Softer Touch Proposal

Momenta’s Generic Lovenox Gets FDA Approval: Implications For Competitors, Follow-On Biologics

FDA Opioid REMS Advisory Committee Preview

Weight Loss Drugs and FDA: Post-Qnexa Update

Vivus Qnexa Turned Down by Committee, but Path Forward May be Open