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27

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Patent Litigation Settlements: Critically Necessary to Ensure Prompt Generic and Biosimilar Market Entry

Earlier this month, the Association for Accessible Medicines and its Biosimilars Council (“AAM”) announced the release of a report, titled “Assessment of the Impact of Settlements,” examining the effects of patent litigation settlements on patient savings and access to generic drugs and biosimilar biological products.  The report, based on research and analysis undertaken by the IQVIA Institute for AAM, concludes “that patent settlements between brand and generic/biosimilar medicine manufacturers accelerated patient access to generic and biosimilar medicines to market by, on average, more than five years before patent expiration,” and that there were significant healthcare system savings....[FDA]

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Medicines for Europe voices shock at ‘concerted efforts’ to water down CMA

Medicines for Europe has expressed shock at the “concerted efforts” of some Member States...

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Ministero Salute - Riportare in Italia la grande produzione farmaceutica di base

Dobbiamo riportare la produzione dei principi attivi in Italia, riportare in Italia o in Europa la grande...

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FIS investe 20 milioni per rafforzare la capacità produttiva

Il gruppo che fornisce principi farmaceutici ai principali player globali, controllato da Bain Capital...

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EMA: linee guida sulle variazioni per una gestione più efficiente

Comunicazione della Commissione C/2025/5045 - Orientamenti riguardanti i particolari delle diverse categorie...

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