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Healthcare & Pharmaceuticals Blog

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  • Blog: Waller Law BlogOne of the hidden benefits of Regulation A+ offerings: variable pricingPosted on June 18, 2018 by Marc J. Adesso
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  • Blog: Biologics BlogFirst Decision on Label Carve-Outs for Biosimilars Expected in Enbrel LitigationPosted on June 17, 2018 by
    As biosimilar litigation between Amgen, the maker of Enbrel® (etanercept), and Sandoz, the maker of biosimilar ErelziTM (etanercept-szzs) heads toward trial before Judge Claire Cecchi in the District of New Jersey, Sandoz is seeking to stave off Amgen’s infringement claims for three of the patents in suit by pointing to its recent amendment to the [...]
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  • Blog: Haynes and Boone BlogsEmployer Document Retention Policies: Relevant ERISA RequirementsPosted on June 14, 2018 by Haynes and Boone Benefits Group
    Many employers maintain policies for compliance with the various laws governing document retention. In developing such a policy, it is important for employers to consider the rules applicable to documents related to plans subject to ERISA: Section 107 of ERISA mandates a six-year document retention period for purposes of its reporting and disclosure requirements (e.g., […] The post Employer Document Retention Policies: Relevant ERISA Requirements appeared first on Haynes and Boone Blogs.
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  • Blog: EndpointsFederal “Right to Try”: Don’t Disregard Your State Laws Just Yet!Posted on June 12, 2018 by Academic and Clinical Research Group
    How Federal Preemption (or Lack Thereof) Could Influence the Use of Federal “Right to Try” As discussed in our Alert of June 4, “Right to Try” Comes to the Federal Stage: What Stakeholders Should Do Now, manufacturers, patients, providers and IRBs are now grappling with two alternative federal pathways through which manufacturers may (but are not required) to provide investigational drugs for treatment purposes outside of an FDA-overseen clinical investigation. As manufacturers, treating physicians, institutions, and other stakeholders pause to consider [...]
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