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  • Article

    Draghi Report On EU Competitiveness Offers New Recommendations For Pharma And Biotech

    The European Commission's comprehensive report on the future of European competitiveness has identified critical challenges facing the pharmaceuticals industry as well as among a range of other sectors across Europe.
    European UnionFood, Drugs, Healthcare, Life Sciences
    Osborne Clarke LLP
    Osborne Clarke LLP
  • Article

    The New EU "Pharma Package": The Debate On Fiscal Import In The Supply Chain

    In our first alert in this weekly series on the EU Pharma Package, we provided some important background and general information about the status of the Pharma Package and how the trilogues work. In the second alert, we discussed the proposed changes to regulatory data protection
    European UnionFood, Drugs, Healthcare, Life Sciences
    Crowell & Moring LLP
    Crowell & Moring LLP
  • Article

    The New EU "Pharma Package": Regulatory Data Protection – A Comparison Of Commission/Parliament/Council Positions

    Although the European Commission, European Parliament and the Council of the European Union all agree on reducing the baseline protection period, the three institutions differ as regards the modulation system for extensions to the baseline period.
    European UnionPrivacy
    Crowell & Moring LLP
    Crowell & Moring LLP
  • Article

    EU Pharma Package: Advertising Compromise Proposal

    In our ninth alert in this EU Pharma Package Series, we discussed the proposals of the Commission, Council, and Parliament with respect to advertising of medicinal products.
    BelgiumFood, Drugs, Healthcare, Life Sciences
    Crowell & Moring LLP
    Crowell & Moring LLP
  • Article

    National Advertising Division Issues Decision On "0 G Added Sugars" Claim For Oatmilk

    Oatly, Inc. has chosen to discontinue its "no added sugars" advertising claims after the Campbell Soup Company brought a challenge before the National Advertising Division (NAD)
    BelgiumFood, Drugs, Healthcare, Life Sciences
    Hogan Lovells
    Hogan Lovells
  • Article

    The New EU "Pharma Package": Global (Orphan) Marketing Authorization

    In this fifth alert in our weekly series on the EU Pharma Package, we will delve into the global marketing authorization (GMA) concept which has largely remained untouched in the legislative proposal...
    European UnionFood, Drugs, Healthcare, Life Sciences
    Crowell & Moring LLP
    Crowell & Moring LLP
  • Article

    Belgian Pharma Law Summer Blog Series (Part 2): The New ‘Article 10 Guidance’ On Pharmaceutical Promotion

    The Belgian Federal Agency for Medicines and Health Products has issued comprehensive new guidance on pharmaceutical promotion to healthcare professionals, consolidating previous circulars and introducing stricter...
    BelgiumFood, Drugs, Healthcare, Life Sciences
    ALTIUS
    ALTIUS
  • Article

    HFSS Newsletter | February 2024

    Despite the delay in implementing marketing and advertising restrictions for products high in fat, salt or sugar (HFSS), there have been some important developments in relation to HFSS.
    GlobalMedia, Telecoms, IT, Entertainment
    Osborne Clarke LLP
    Osborne Clarke LLP
  • Article

    Europe—General Court Confirms Obligation To Prove Significant Benefit Over All Authorized Medicinal Products, Including Those Authorized After The Submission Of The Marketing Authorization Application For The Future (Orphan) Product

    On December 5, 2018, the General Court (Court) ruled in favor of the European Commission in a case brought by Bristol-Myers Squibb Pharma (BMS) ...
    European UnionFood, Drugs, Healthcare, Life Sciences
    Mayer Brown
    Mayer Brown
  • Article

    State And Federal Food-Labeling Reforms Impose Unappreciated Complexities And Compliance Challenges

    Food product labels are under intense scrutiny from consumers, regulators, class action lawyers, and non-governmental organizations (NGOs).
    BelgiumFood, Drugs, Healthcare, Life Sciences
    Hogan Lovells
    Hogan Lovells
  • Article

    The New EU "Pharma Package": The Transferable Exclusivity Voucher—A Comparison Of Commission/Parliament/Council Positions

    In our first alert in this weekly series on the EU Pharma Package we provided some important background and general information about the status of the Pharma Package and how the trilogues work...
    European UnionFood, Drugs, Healthcare, Life Sciences
    Crowell & Moring LLP
    Crowell & Moring LLP
  • Article

    EU Pharma Package: The “Bolar” Exemption Compromise Proposal

    In our sixth alert in this EU Pharma Package Series, we provided an analysis of the history and interpretation issues for another highly debated topic: the “Bolar” exemption.
    BelgiumIntellectual Property
    Crowell & Moring LLP
    Crowell & Moring LLP
  • Article

    EU Pharmaceutical Reforms To Overhaul Marketing And Manufacturing Rules

    Advertising, marketing authorisation applications and imports are among the areas targeted by the draft proposals...
    European UnionFood, Drugs, Healthcare, Life Sciences
    Osborne Clarke LLP
    Osborne Clarke LLP
  • Article

    Administration Presents Plans To Lower Drug Prices

    On May 11, 2018, President Trump and Department of Health and Human Services (HHS) Secretary Alex Azar delivered highly anticipated speeches regarding the Administration's plan to reduce drug prices.
    BelgiumFood, Drugs, Healthcare, Life Sciences
    Hogan Lovells
    Hogan Lovells
  • Article

    European Commission Study On The Economic Impact Of Retail On Choice And Innovation In The EU Food Sector

    On 2 October 2014, the European Commission published a study on the evolution of the European food retail market over the last ten years.
    European UnionAntitrust/Competition Law
    Van Bael & Bellis
    Van Bael & Bellis
  • Article

    The New EU "Pharma Package": Interplay With The Critical Medicines Act And Other Shortage Initiatives

    In this eighth alert in our weekly series on the EU Pharma Package, we continue our overview of initiatives with respect to security of supply and shortage prevention and mitigation.
    European UnionFood, Drugs, Healthcare, Life Sciences
    Crowell & Moring LLP
    Crowell & Moring LLP
  • Article

    Life Sciences Patents Monthly Roundup—May 2026

    This month, at the Unified Patent Court (UPC), the Düsseldorf Local Division’s dismissal of Align Technology’s provisional measures application against Angelalign reinforces the applicant’s evidential...
    European UnionIntellectual Property
    A&O Shearman
    A&O Shearman
  • Article

    EU Geopolitical Risk Update - Key Policy & Regulatory Developments No. 119

    This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia's war against Ukraine, health threats, and cyber threats.
    European UnionTechnology
    Jones Day
    Jones Day
  • Article

    Food Law | UK Regulatory Outlook January 2024

    Food label changes for non-UK FBOs | Increasing scrutiny and enforcement for greenwashing relating to food | Uncertainty on food waste reporting...
    BelgiumFood, Drugs, Healthcare, Life Sciences
    Osborne Clarke LLP
    Osborne Clarke LLP
  • Article

    The New EU "Pharma Package": Access Conditionalities And Shortage Measures – A Comparison Of Commission/Parliament/Council Positions

    In this seventh alert in our weekly series on the Pharma Package, we will discuss the increasing focus on shortages of medicinal products in the EU and the prevention...
    BelgiumFood, Drugs, Healthcare, Life Sciences
    Crowell & Moring LLP
    Crowell & Moring LLP

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