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 le...

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...

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 f...

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 prot...

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 challen...

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...

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 inn...

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 transp...

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 directive...

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 cou...

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 Diagno...

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 exp...