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2022 spells change for EU pharmaceutical legislation

European Pharmaceutical Review

Following initial consultations in 2021, we expect the publication of the proposal for changes to the EU’s pharmaceutical legislation and potential adoption by the European Commission (EC) by December 2022. He focuses his practice on EU regulatory affairs, litigation and competition law issues affecting the life sciences sector in Europe.

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How to get acquisition ready – a seller’s guide to merger and acquisition in pharma

pharmaphorum

M&A is an integral part of the lifecycle of pharma companies and a key strategy to future-proof larger players, driving R&D activities and innovation for a competitive product pipeline. In addition, she worked as head of inspectorate and licensing for the MHRA from 2004-2006. About the author. She joined NSF in 2017.

Pharma 119
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The EU HTA regulation: a new frontier for access to innovative technologies

European Pharmaceutical Review

Article 15 proved that transparent and effective assessments of new technologies were crucial to ensure fair competition between stakeholders that operate in the EU. In addition, he was Head of the Legal Service at the European Medicines Agency from 2004 to 2012.

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The Evolution of Biosimilars from Their Beginning Until Now—And What’s Next

PM360

PM360 spoke to Kokino about the evolution of the biosimilars market from its nascent days, why the now increased competition within the market is causing some companies to reconsider developing biosimilars, what to look for over the next few years, and how Accord’s approach is a bit different from what other companies are doing.

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Biogen’s $900 million settlement signals scrutiny on speaker fees

Pharmaceutical Technology

As per the US Department of Justice, Biogen paid remuneration in the form of training and consulting fees and speaker honoraria, to induce physicians to prescribe the company’s drugs, in violation of the Anti-Kickback Statute. More recently, Biogen has been facing competition from dimethyl fumarate generics.

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Five potential EU regulatory changes impacting the life sciences industry in 2023

European Pharmaceutical Review

Following publication of the proposal, the European Commission launched an eight-week public consultation. The stakeholder consultation resulted in 246 comments and ended on 18 January 2023. However, the eight-week period was quickly shortened to eight days.

Medical 117
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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

4,6 Traditional Herbal Registration The Traditional Herbal Medicines Directive (Directive 2004/24/EC) is implemented in the UK by the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005 and came into force on 30 April 2011. Premier Consulting [Internet]. 2012/1916). 2018 [cited 2024May]. Ethnopharmacol.

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