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Recent And Upcoming FDA Advisory Committee Meetings

Executive Summary

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

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Horizon Teprotumumab's US Advisory Cmte. Likely To Focus On Labeling, Not Approval, Questions

FDA seems poised to approve the drug for the orphan eye disease called TED, but remains concerned about labeling for some adverse events.

Brinavess Rejected By Advisory Cmte., Leaving US FDA To Mull Lifting Clinical Hold On Correvio's AFib Drug

Cardiovascular and Renal Drugs Advisory Committee voted 11-2 against approval for Correvio's atrial fibrillation drug Brinavess over cardiovascular safety concerns; the agency would have to lift the long-standing  clinical hold on the drug before the company can do any further study in humans.

Lynparza, Keytruda Supplemental Indications Face US FDA Panel Review

AstraZeneca and Merck seek to add a pancreatic cancer indication for olaparib, while Merck has hopes of broadening pembrolizumab’s use in bladder cancer; two-day Oncologic Drugs Advisory Committee meeting also will include reviews of Celgene’s luspatercept in myelodysplastic syndromes-related anemia and Epizyme’s tazemetostat for epithelioid sarcoma.

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