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Ramsey Baghdadi

Ramsey Baghdadi covered regulation, reimbursement, and legislative policy for over a decade as Editor-in-Chief of The RPM Report and a contributing editor to Pink Sheet. He previously served as managing editor for the OTC drug and dietary supplement industry publication The Tan Sheet. Prior to his work in the drug sector, he covered the medical device industry as financial editor of The Gray Sheet.
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Latest From Ramsey Baghdadi

Deciphering US FDA’s Keytruda Safety Announcement

Safety notice for Merck's Keytruda in multiple myeloma had some notable elements – from what comes next to who delivered the message.

Cancer Drug Safety

The Return of The Pazdur Moment

US FDA’s top cancer drug reviewer has been uncharacteristically quiet during recent advisory committee meetings. That just changed, and the result may not have been great for the sponsor (Pfizer), but it is a reminder of the value that Pazdur’s institutional knowledge and outspokenness bring to all of FDA.

Advisory Committees Cancer

Pfizer Sutent Label Expansion May Hinge On Disease-Free Survival Stats

Conflict of interest waivers for US FDA advisory committee review of sunitinib's supplemental application signal that difference in statistical analyses for disease-free survival could be key area of discussion.

Clinical Trials Advisory Committees

FDARA: The Forgotten Health Care Bill

The White House missed an opportunity to tout a major legislative accomplishment in the first year of President Trump’s term.

United States FDA

Breakthrough Requests Keep Climbing

Sponsors are seeking US “Breakthrough Therapy” Designations at a record pace in FY 2017.

Drug Review Regulation

Kite’s Axi-Cel CAR-T: No Adcomm, No Problem

Next CAR-T in line at US FDA, Kite’s axicabtagene ciloleucel, looks headed toward an early approval with the agency confirming no panel will be scheduled, according to the firm. But the company and FDA may have benefited from an advisory committee review.

Advisory Committees Drug Review
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