Explorez tous les épisodes du podcast Talking Life Sciences

In this episode of Covington's Life Sciences Podcast, Mosa Mkhize and Deon Govender discuss Regulatory and policy developments from South Africa: SAHPRA's proposed Black Economic Empowerment (BEE) policy and its potential impact on license holders for medicines and medical devices

In this episode of Covington's Life Sciences Podcast, Mosa Mkhize and Grant Castle discuss developments in the African Medicines Agency and regulatory convergence.

In this episode of Covington's Life Sciences Podcast, Mosa Mkhize and Roderick Dirkzwager discuss WHO prequalification procedures in Africa.

In this episode of Covington's Life Sciences Podcast, Seán Finan discuss some important recent developments in the regulation of sustainability and green claims and labelling schemes, and the ever-increasing enforcement risk that comes with greenwashing.

In this episode of Covington's Life Sciences Podcast, Marie Doyle-Rossi, Anna Wawrzyniak, and Valeria Sturla discuss the position adopted by the European Parliament on 10 April 2024 on the Commission proposal to reform the core EU pharmaceutical legislation.

Parliament's position comes less than a year since the Commission published its proposal, and constitutes a significant step in the legislative process. Although many of the Parliament's amendments to the Commission proposal can be seen as improvements by the innovative industry, many challenges and some unresolved questions remain, especially in relation to the incentive regime.

During this audiocast, we therefore discuss improvements, challenges and unresolved questions of the EU Pharma law review, with a particular focus on incentives.

Tune into this episode of Covington's Life Sciences Podcast, where Sibel Yilmaz, Majken Lagerbielke, and Leire Garagorri Eguidazu discuss the new market definition notice published by DG COMP, specifically the latest on the new guidance concerning pharmaceutical innovation markets and possible implications for analysing M&A and licensing deals.

Tune into this episode of Covington's Life Sciences Podcast, where Winsome Cheung and George Jenkins discuss the key trends in Life Sciences Transactions for 2024. The speakers discuss the outlook for deal-making in Life Sciences and predictions for deal trends, including in relation to nuclear medicine, GLP-1, antibody-drug conjugates and other modalities. The speakers also discuss some of the key legal considerations that are coming into increasing focus for Life Sciences Transactions, such as competition/antitrust considerations and the Inflation Reduction Act. This is the first Life Sciences Transactions audiocast for 2024, and we plan to release further audiocasts over the course of this year that dive deeper into some of the above topics.

Recently announced changes to the Voluntary Scheme (VPAG) and Statutory Scheme change the paradigm for the pricing of branded medicines in the UK. Innovative pharmaceutical companies doing business in the UK must decide which scheme to join for 2024 – a decision that may significantly affect margins.

Tune into this episode of Covington's Life Sciences Podcast, to hear the latest on these changes from our experts, Grant Castle, Raj Gathani and Daniel Spivey.

Supplementary Protection Certificates (SPCs) are a form of patent term extension right that are available in the EU for medicinal products.

Tune into this episode of Covington's Life Sciences Podcast where Inga Pietsch and Roderick Dirkzwager discuss some of the developments in SPC case law from the European Court of Justice in relation to the SPC grant requirement that a product must be protected by a basic patent in force and take a closer look at the Commission's proposal to update the EU SPC regime to introduce a new unitary SPC

Tune into this episode of Covington's Life Sciences Podcast, 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 potential ways to address these challenges when structuring and negotiating these transactions.

Tune into this episode of Covington's Life Sciences Podcast, 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 UK's newly proposed international reliance routes that will allow UK regulators to recognize approvals from a number of trusted jurisdictions and the potential benefits of these routes.  Finally, the speakers will highlight the future plans for medical devices.

Tune into this episode of Covington's Life Sciences Podcast 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 each approach as companies look to develop and augment their innovative pipelines and continue to expand their portfolio and geographical reach.

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 Podcast, where Robin Blaney and Roderick Dirkzwager look at the new transparency requirements and the opportunities for sponsors to redact or defer the publication of commercially confidential information.

In this episode of Covington's Life Sciences Podcast, Sarah Cowlishaw and Ellie Handy discuss the recent changes to the MDR and IVDR.  Our speakers discuss the European Commission's recently adopted Regulation (EU) 2023/607, which extends the transitional periods in the EU Medical Devices Regulation (EU) 2017/745 (the "MDR") for certain eligible devices CE marked under the previous directives.  The Regulation also removes the "sell-off" periods for devices and in vitro diagnostic devices from both the MDR and In Vitro Diagnostic Device Regulation (EU) 2017/746 (the "IVDR").  Our team discuss how these provisions will apply and the practical implications of the changes for the medical device sector in the EU and UK.

Complex international pharmaceutical supply chains often separate the physical flow of product from financial flows or flows of legal title. Tune in to this episode of Covington's Life Sciences Podcast, where Grant Castle, Robin Blaney and Marie Doyle-Rossi, discuss how the EU and UK pharmaceutical rules seek to regulate these tax and commercial structures. Some recent key developments could have significant implications for global supply chains.

Tune into the third episode of Covington's Life Sciences Podcast, where Grant Castle, Stefanie Doebler, and Raj Gathani discuss social media challenges for pharma companies in Europe and the U.S.

Tune into the second episode of Covington's Life Sciences Podcast, where Sarah Cowlishaw, Ellie Handy, and Léna Beley discuss key developments in the medical device sector in the EU and the UK. Our speakers review the major legal developments for medical devices in the last few years, including the issues surrounding the entry into force of the Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation and the proposed measures to address them, the implications of the EU's proposed Artificial Intelligence ("AI") Act for software medical devices, and the effects of Brexit on the regulation of medical devices in the UK.

Our experts present the current state of play in the EU and the UK, and how these developments are expected to shape the coming years for medical devices.  

Please note that since the date of recording this podcast, an agreement in principle has been reached by the UK and EU relating to post-Brexit trade issues in Northern Ireland. This agreement in principle is being referred to as the "Windsor Framework". Unlike the position for medicines, the Windsor Framework does not include any changes to the regulatory arrangements for placing medical devices on the market in Northern Ireland.

Tune into the first episode of Covington's Talking Life Sciences Podcast, where Grant Castle, Peter Bogaert and Marie Doyle-Rossi discuss key developments and trends in the pharma sector. Our speakers review the major issues of 2022, including the Clinical Trials Regulation, the Health Technology Assessment Regulation, European Health Data Space proposal and Brexit. Looking forward, our experts highlight the themes expected to shape the year ahead, in particular the revision of the EU pharma legislation and imminent publication of the Commission's proposal and draft legislation.

Our speakers offer valuable insights on how these developments might affect companies in the pharma industry.