Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


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.

Latest From Ramsey Baghdadi

Real-World Views On RWE: RECOVER Trial Seen As US Answer To UK’s RECOVERY

US FDA Commissioner Robert Califf held court with global regulators to discuss the overall state of real-world evidence and how different agencies across the world view it.

Real-World Evidence Clinical Trials

US FDA Office Of Immunology Turnover Tests Updated Review Structure

A leadership transition in FDA’s Office of Immunology & Inflammation will elevate former rheumatology division Director Nikolay Nikolov to the top spot – with a number of interim and inexperienced leaders in the management layers below.

Leadership Drug Review

The Gene Therapy Wave Is Here

The long-talked about wave of gene therapy approvals is beginning to reveal itself.

Gene Therapy Review Pathway

Will The Excise Tax Torpedo The IRA Drug Price Negotiation Program?

A case involving a tax that was an “exceedingly heavy burden” and played into the Supreme Court’s original ruling on the ACA could reemerge once the IRA challenge reaches the high court.

Pricing Debate Legal Issues

Using A Natural History Study As An External Control In Rare Diseases: Ipsen Offers An Example

Although the advisory committee was uncomfortable with the external control, US FDA was reassuring over the approach – which eventually secured a ‘yes’ vote from the panel on palovarotene for FOP.

Advisory Committees Rare Diseases

Artificial Intelligence Legislative Activity To Start In Fall; Sen. Schumer Lays Out Principles, Process

As US FDA offers initial issues for industry consideration, Senate majority leader outlines framework and process of a bipartisan effort to construct the ‘first of its kind’ legislation to regulate AI.

Digital Health Legislation
See All