Tune into this episode of Covington’s Life Sciences Audiocast, where Winsome Cheung, Lauren Pignataro Rakitin and Sibel Yilmaz discuss cell and gene therapy collaboration and licensing deals. The speakers discuss the commercial, IP and antitrust issues commonly faced by pharma and biotech companies as they seek to partner in this evolving landscape, and
EU Talking Life Sciences Audiocast: The UK’s Medicinal Product and Medical Device Reliance Routes
Tune into this episode of Covington’s Life Sciences Audiocast, where Grant Castle, Marie Doyle Rossi, and Ellie Handy discuss the UK’s recent announcement of new international reliance routes for medicinal products and medical devices. The speakers will discuss existing EU reliance procedures offered by the UK. They will then set out the
EMA Releases Reflection Paper on AI/ML in the Medicinal Product Lifecycle
Hot on the heels of recent announcements from the U.S. Food and Drug Administration (see our prior blogs here), the European Medicines Agency (“EMA”) has joined the conversation on the use of Artificial Intelligence (“AI”) and Machine Learning (“ML”) technologies in the medicinal product lifecycle.
AI and ML have the potential to enhance every
EU Talking Life Sciences Audiocast: Current Trends in M&A and Licensing in the Life Sciences Industry
Tune into this episode of Covington’s Life Sciences Audiocast where Winsome Cheung and Gregor Frizzell discuss some new and emerging M&A and licensing trends in the Life Sciences industry. Our speakers discuss some of the motivating factors for why parties decide between the two and some of the key differences and pros and cons of
Pathogen Access and Benefit-Sharing (P-ABS) under the draft WHO Pandemic Treaty: Why Many Vaccine, Therapeutic, and Diagnostic Companies will be in Scope
By May 2024, the 194 countries of the World Health Organization (“WHO”) aim to finalize negotiations on a new international treaty on pandemic prevention, preparedness and response (“Pandemic Accord”). At the center of the negotiations is the contentious issue of Pathogen Access and Benefit-Sharing (“P-ABS”). In this blog we explain how this will directly affect
Germany to enact new law with significant changes to drug pricing and reimbursement rules
In an earlier blog, we noted that the German drug pricing and reimbursement laws are among the most complicated legal areas in the entire field of life sciences law. Now, these laws and the respective German market access rules are becoming more complicated. A new law will come into effect in the next few
Germany plans Health Data Use Act and stricter pricing & reimbursement rules for Digital Health Apps
At the end of June 2023, a draft Health Data Use Act (“GDNG”) and a draft Digital Act (“DigiG”) of the German Federal Ministry of Health have become public. These drafts are part of the German government’s digitalization strategy for the health sector. The Health Data Use Act plans to grant industry companies an access
EU Talking Life Sciences Audiocast: Clinical Trial Transparency Requirements in the EU
The EU Clinical Trials Regulation 536/2014 significantly expanded the transparency requirements for clinical trials in the EU, resulting in the public availability of most documents and information submitted by sponsors to the new EU Clinical Trial Information System. Tune into this episode of Covington’s Life Sciences Audiocast, where Robin Blaney and Roderick Dirkzwager look
The EU member states’ votes banning a product cannot be presumed confidential: Why we litigated Case T-201/21 Covington & VanVooren vs European Commission (and won)
In short
We won Case T-201/21 Covington & Van Vooren vs European Commission. But why did we litigate? Why did we ask to see how the member states voted on an EU implementing act? A short background story, worth a few minutes of your time if interested in the EU as a democracy…
The
Historic Marine Biodiversity Treaty creates new Access and Benefit-Sharing obligations for life sciences companies
On 19 June 2023, after almost 20 years of negotiations, the United Nations (“UN”) member states adopted a landmark treaty to ensure the conservation and sustainable use of marine Biodiversity of areas Beyond National Jurisdiction (the “BBNJ” treaty).
One of the cornerstones of the BBNJ treaty is the creation of a new mechanism for the