Generics Bulletin 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

Laura Helbling

Laura Helbling is Director of Research at Prevision Policy and a Senior Writer at The RPM Report (now Pink Sheet). Laura has a degree in magazine journalism from the University of Missouri School of Journalism.

Latest From Laura Helbling

US FDA Drug Center Tries New Approach To Old Consistency Problems

Drug developers should not expect the US FDA's new Quantitative Medicine Center of Excellence to dramatically impact the agency's long-standing problem of ensuring more consistent use of innovative regulatory approaches in application reviews.

Clinical Trials Review Pathway

Drug Shortage Could Be Addressed By ‘Resilience Rating’ From Private Entity Under HHS Plan

US HHS is proposing a public-private partnership to assign ratings to manufacturers based on quality/resilience of supply, tied to a purchasing incentive program for providers. The non-agency approach may be key to overcoming industry and political objections.

Manufacturing Reimbursement

Drug Shortage Could Be Addressed By ‘Resilience Rating’ From Private Entity Under HHS Plan

US HHS is proposing a public-private partnership to assign ratings to manufacturers based on quality/resilience of supply, tied to a purchasing incentive program for providers. The non-agency approach may be key to overcoming industry and political objections.

Manufacturing Reimbursement

A Final Push For US Hepatitis C Eradication Plan In 2024

The Biden Administration is hoping that it can attach funding for a national hepatitis C ‘subscription’ program into the delayed fiscal 2024 appropriations bills.

Reimbursement Legislation

Menopausal Status Is Another Focus For US FDA Trial Inclusion Efforts

US FDA is emphasizing the need to assess the effects of menopause on drug safety and efficacy as a continuation of the agency’s efforts to encourage clinical trial sponsors to look more systematically for differences in clinical trial subpopulations.

Diversity & Inclusion Clinical Trials

Gene Therapy Cost Effectiveness: US ICER Supports Million-Dollar Prices

Institute for Clinical and Economic Review continues to assign high values to novel gene therapies, suggesting that Orchard’s pending ‘arsa-cel’ for MLD could be cost effective at a price as high as $4 million per treatment.

Gene Therapy Reimbursement
See All
UsernamePublicRestriction

Register