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Drug development and working with specialised Rare Disease networks

pharmaphorum

During the course of the webinar, Keefer explained how specialty sites, with deep knowledge on one or certain groups of Rare Diseases, are crucial for further progress in drug development to progress the number of treatments available to Rare Disease patients and to provide support to those individuals. Headway being made.

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How to Run DMC? It’s Tricky – FDA’s New Draft Guidance Provides Updated Recommendations on How to Best Use Data Monitoring Committees in Clinical Trials

FDA Law Blog: Biosimilars

Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring Committees” and, when final, will replace the 2006 guidance.

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How Real-World Data is Helping Speed Oncology Drug Development

Drug Channels

Read more » Copyright © 2006-2020 Pembroke Consulting, Inc. d/b/a Drug Channels Institute. Drug Channels® is a registered trademark of Pembroke Consulting, Inc. To learn more, visit the Ontada website. This Feed is for personal non-commercial use only.

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2022 spells change for EU pharmaceutical legislation

European Pharmaceutical Review

But what are the key potential changes and how could they impact drug developers and manufacturers? He noted that within the proposals, there is likely to be a differentiation in incentives for drug development in the orphan and unmet medical need areas. THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION; 2006.

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Six Trends to Watch in the New Healthcare Economy

Drug Channels

Karen examines trends in drug development, pricing, and healthcare. Read more » Copyright © 2006-2021 Pembroke Consulting, Inc. d/b/a Drug Channels Institute. Drug Channels® is a registered trademark of Pembroke Consulting, Inc. She also serves as co-chair of Maintenance and Control at the NCPDP.

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Chiesi expands rare disease portfolio with Amryt Pharma acquisition

pharmaphorum

The transaction will be effected by means of a UK scheme of arrangement under Part 26 of the UK Companies Act 2006, subject to approval of Amryt shareholders, sanction by the High Court of Justice of England and Wales, and other customary closings, including regulatory/antitrust approvals.

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Gene therapy: a radical pharmaceutical revolution

European Pharmaceutical Review

In this Q&A, Karen Pinachyan, Head of Medical Affairs Europe at CSL Behring summarises key considerations for gene therapy drug development and the ideal approach for alleviating economic strain when advancing these modern treatments. 4,5 What is the key consideration drug developers should apply to gene therapies?