The Debt Ceiling and Biopharma: Update As Deadline Nears

House FDA Hearing Includes Discussion of TNF Blockers and Safety Monitoring

Drug Review Dossier: Alogliptin; Fixed-Dose Alogliptin/Pioglitazone Combo

Generic Lipitor: 180-Day Exclusivity Remains Unsettled

CMS Says It Will Not Alter Coverage Policy on Avastin Regardless of Final FDA Decision

Avastin Withdrawal Hearing: ODAC Votes to Remove Indication, Next Step Is FDA Commissioner Decision

Avastin Withdrawal Hearing Day Two Midday Update: Roche/Genentech Makes Its Case, AdComm Still Appears Unswayed

Roche/Genentech’s Hearing Request: Riskier Process In Practice Than In Concept

Avastin Withdrawal Hearing Day One: Advisory Committee Doesn’t Show Signs of a Switch

Avastin Withdrawal Hearing Mid-Day Update: FDA Buttresses Arguments against Avastin PFS Results with Amgen Study

Advisory Committee Tracker: Brentuximab, Dapagliflozin Headline July Meetings

FDA Puts ESA Ceiling at 11 g/dl in Dialysis, Asks for Additional Trials

Avastin Hearing Preview: Odds Against Genentech

Shire’s Firazyr: FDA Panel Overwhelmingly Endorses Efficacy with Approval Recommendation

The End of the Priority Review Vouchers? Novartis Ilaris Panel Illustrates Real-World Limits of Program

Novartis’ Ilaris: FDA Panel Rejects Gout Drug

Shire’s Firazyr for HAE: FDA Briefing Documents Indicate It’s All about Interpretability of Efficacy

Drug Review Dossier: Aclidinium

Part D Rebates Bill Drops: Five Reasons Why the Prospects for Passage Should Not Be Dismissed

Regeneron’s Eylea for AMD: FDA Panel Recommends Unanimous Approval, Every-Other-Month Dosing

Drug Review Dossier: ruxolitinib

Regeneron’s Eylea for AMD: FDA Briefing Documents Show Approvability Not In Question; Dosing Regimen/Advantage At Stake

FDA Has 17 Novel Drug/Biologic Approvals by Mid-June; Only 21 for All of 2010

FDA Office of Compliance Elevated to “Super” Status; Higher Profile Issues Bring Higher Profile Office

Orexigen Halts Contrave Development in U.S.: What Does It Mean For the Obesity Class?