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  1. Legal news
    11 December 2018
    The legal basis for Belgian biobanks enters into force
    www.twobirds.com/en/news/articles/2018/belgium/the-legal-basis-for-belgian-biobanks-finally-enters-into-force

    Each Belgian biobank will have to be declared at the Federal Agency for Medicines and Health Products (FAMHP) in order to operate. It also imposes binding content for agreements on the transfer of human biological ...

  2. Legal news
    11 December 2018
    Changes afoot for Belgian manufacturers of allogeneic ATMPs
    www.twobirds.com/en/news/articles/2018/belgium/changes-afoot-for-belgian-manufacturers-of-allogeneic-atmps

    Last month, the Belgian Parliament voted in favour of a set of measures that are notably meant to clarify the regulatory landscape of the operators active in the manufacturing of Advanced Therapy Medicinal Products ...

  3. Legal news
    11 December 2018
    Pemetrexed: Italian Court reversed the first instance decision ordering a PI on the basis of Eli Lilly's patent
    www.twobirds.com/en/news/articles/2018/italy/italian-court-reversed-the-first-instance-decision-ordering-a-pi-on-the-basis-of-eli-lillys-patent

    Diverging from the previous decision, the Court pointed out that the relevance of the file history to construe the scope of protection of a patent and then the infringement of equivalence has to be carefully and ...