18 Apr, 2024 Managed Entry Agreements (MEAs) under scrutiny once more in Belgium By Jean-Christophe Top Joost Haans Marco de Morpurgo Lyndsey Hudson +1 more... Show less Impressive advancements in the pharma industry provide hope to patients affected by debilitating and life-threatening diseases and a...
12 Mar, 2024 Life Sciences Regulation in the EU: Overview By Marco de Morpurgo Nicola Landolfi Nadia Feola Heidi Waem +1 more... Show less DLA Piper's Life Sciences Regulatory team, led by Marco de Morpurgo, recently produced a Q&A guide to life sciences regulation in the EU...
08 Jan, 2024 Portugal | Removal of the retail price of medicines from labelling and packaging By Mariana Ricardo Since 2006, when the Medicines Code was approved in Portugal, marketing authorisation holders had to include the retail selling price of...
21 Dec, 2023 Our predictions for life sciences in 2024 By DLA Piper Life Sciences As the New Year is fast approaching, we asked members of our international Life Sciences team to share their predictions of what will be...
23 Nov, 2023 UK CMA publishes Competition Law Guidance for Cooperations on Combination Therapies By Alexandra Kamerling Executive Summary Combination therapies involve the use of two or more separate medicines in combination to treat a disease. It can be...
29 May, 2023 EU Pharma Law Forum 2023 - competition highlights By Joost Haans On 23 May 2023, Joost Haans from our Life Sciences team attended the EU Pharma Law Forum in Brussels where he participated in the...
26 May, 2023 EU Pharma Law Revision: First Reactions and Next Steps By Marco de Morpurgo Laetitia Mouton Mary Foord-Weston Exactly one month ago, on 26 April 2023, the European Commission (EC) adopted its long-awaited proposal for the revision of the EU...
19 May, 2023 Brazilian Health Regulatory Agency updates regulation that governs requirements for clinical laboratory tests By Bruna Rocha Juliana Marcondes Victoria Cristofaro On May 3rd of this year, Anvisa approved Resolution No. 786/2023 ("RDC 786/2023"), which addresses the technical and health requirements...
28 Apr, 2023 The UK voluntary scheme for branded medicines pricing and access (VPAS): just what the doctor ordered, or a bitter pill to swallow? By Michael Stead Martha Pownall On the 1 April this year, amidst storm clouds gathering above the NHS in the form of staffing strikes, record waiting times and chronic...
12 Apr, 2023 The New Italian Public Contracts Code By Giorgia Romitelli Roberta Moffa Anna Mazzoncini Riccardo Scioscia +1 more... Show less As of March 28, The Italian Council of Ministers have approved the new Public Contracts Code. The Legislative Decree No. 36 of March 31,...
04 Apr, 2023 You say “ed”, they say “ad”: The fine line between lawful educational campaigns and unlawful advertising of therapeutic goods in Australia By Nicholas Tyacke Greg Bodulovic Alexandra de Zwart Companies operating in the life sciences industry play a vital role in raising awareness of diseases and other medical conditions,...
14 Mar, 2023 Advertising therapeutic goods in Australia (don't let your ad make you sad) By Nicholas Tyacke Greg Bodulovic Alexandra de Zwart Due to a complex array of legislation, regulations and codes, advertising therapeutic goods in compliance with Australian law can be a...
06 Feb, 2023 Poland - Life Sciences Monthly Brief, January 2023 By Andrzej Balicki, Ph.D. Jolanta Dabrowicz Przemysław Matuszewski Urszula Grębowska +1 more... Show less Download a copy of our January monthly briefing, which covers key updates and insights in the following areas: Pharmacies; Clinical...
19 Dec, 2022 FDA Denies Requests for Revocation of EUA for Covid Vaccine for Use in Individuals 5-11 and 12-17 Years of Age By Melissa Gilmore Jarred Reiling Keo Shaw The FDA has denied two citizen petitions filed on behalf of the Informed Consent Action Network (ICAN) requesting the agency revoke its...
08 Dec, 2022 Poland - Life Sciences Monthly Brief, November 2022 By Andrzej Balicki, Ph.D. Jolanta Dabrowicz Przemysław Matuszewski Urszula Grębowska +1 more... Show less We first wrote about the planned amendments to the Pharmaceutical Law and certain other acts (the so-called Verticalisation Act) in...
01 Dec, 2022 FDA publishes draft guidance on active ingredient sameness in proposed generic drugs and their reference listed drugs By Christine Lentz The FDA recently published “Sameness Evaluations in an ANDA – Active Ingredients,” a new draft guidance detailing recommendations for...