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European Commission European Medicines Agency (EMA) Prescription Drugs

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European Biosimilar Regulatory Update

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In the past few weeks, the European Commission provided marketing authorization for biosimilars of denosumab and omalizumab, as well as an ophthalmic formulation of bevacizumab....more

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The European Parliament Adopts Position on the European Commission’s Proposal for the First Major Overhaul of the EU Medicines...

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In April 2023, we published an alert in relation to two European Commission legislative proposals: new Regulation 2023/0131 and new Directive 2023/0132, to replace the current EU regulatory framework for all medicines...more

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A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

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As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

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Biosimilars Update: Bio-Thera Solutions BAT1706 (bevacizumab) and Pfizer RUXIENCE (rituximab)

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Below are a few biosimilar-related updates from the past week. Bio-Thera Solutions announced that in a Phase III clinical trial of BAT1706 (bevacizumab), BAT1706 met its primary endpoint, demonstrating “equivalence in...more

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