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The European Medicines Agency has revised several sections of its 2001 guidance on the development and evaluation of gene therapy medicinal products based on stakeholder feedback and to address issues in light of the experience gained with these products.
New medicines under evaluation at the European Medicines Agency.
The Medicines and Healthcare products Regulatory Agency has issued for consultation proposals on how it will ensure the UK meets its obligations to transpose the safety feature provisions of the EU Falsified Medicines Directive.
As then-Novartis CEO Joe Jimenez worked with former Trump lawyer Michael Cohen on drug pricing issues, the pharma industry was preparing for the debate it's eventually getting to have.
Federal Circuit rules that material about Xyrem's REMS distribution system provided for advisory committee review constitutes prior art.
Focus should not be limited to rebates in Medicare Part D, manufacturers advise in comments on HHS drug pricing blueprint. Pharmacy benefit managers raise anti-trust issues with shift to upfront discounts.
FDA’s latest drug shortages task force aims to encourage investment in the reliable manufacture of generic sterile injectables that are fundamental to the practice of medicine. While the agency’s first task force continues to work with industry to avert shortages, the second will strike at underlying structural issues that cause persistent shortages of these critical medicines.
Enasidenib, which last year became the first US-approved treatment for relapsed or refractory acute myeloid leukemia with an IDH2 mutation, is among a new crop of products being reviewed for marketing approval in the EU.
Development guidance from CBER recommends comparing investigational gene therapy products to existing prophylaxis treatment.
Advisory committee questions about malaria drug’s breakthrough therapy and orphan drug designations reflect lingering confusion about how agency’s various regulatory pathways impact product development and approval.
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