In Vivo 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

UsernamePublicRestriction

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

US FDA’s ALS Science Strategy Includes Near-Term Rare Neurodegenerative Disease Task Force

Five-year plan includes multi-phased approach to ALS at the same time that Amylyx’s AMX0035 is pending review with a late September decision deadline; action plan’s mid-term priorities for FY 2023-2024 include a cell and gene therapies safety project.

Drug Approval Standards Rare Diseases

Senate Commerce Leaders Want An FTC Study Into PBM Business Practices – And More

Committee Chair Maria Cantwell (D-Wash.) solicits advice from witnesses for additional authorities to conduct oversight of PBMs and pushes for a GAO study.

Pricing Debate Policy

Gene Therapy Reviews Return To US FDA Advisory Committee Schedule

The upcoming review of two novel gene therapies from bluebird bio marks will be the first time the US FDA’s CTGTAC has met for a genetic product review in five years. That is a surprisingly long gap – and one that probably will not be repeated.

Gene Therapy Advisory Committees

US FDA Oncology Center Makes Dose Optimization Personal

‘Project Optimus’ is continuing to press forward on reframing the approach to dosing of anticancer drugs. The initiative is very personal to OCE Director Richard Pazdur.

Cancer Clinical Trials

‘Alternative Pathway’ Products Are Key New Challenge For FDA, Woodcock Says

US FDA will have to wrestle with a proliferation of medical products that are coming to market via ‘alternative pathways’ that do not neatly fit under – or sometimes deliberately seek to avoid – the agency’s regulatory authorities, acting commissioner says.

Regulation Drug Approval Standards

Aduhelm In Medicaid: States Must Cover, CMS Official Says

Medicaid’s pharmacy director says the Biogen Alzheimer’s drug is ‘currently a covered outpatient drug.’ As the payer of last resort, Medicaid could find itself significantly impacted by a Medicare national coverage decision.

Medicaid Reimbursement
See All
UsernamePublicRestriction

Register