Nov 23, 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...
May 29, 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...
May 26, 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...
May 19, 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...
Apr 28, 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...
Apr 12, 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,...
Apr 04, 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,...
Mar 14, 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...
Feb 06, 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...
Dec 19, 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...
Dec 08, 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...
Dec 01, 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...
Oct 28, 2022 Considering Modifications to Existing FDA Regulatory Incentives to Achieve Greater Racial and Ethnic Diversity in Clinical Trials for Drug Approvals By Kirsten Axelsen When clinical trials for new drug approvals fail to adequately represent racial and ethnic groups, there is a lost opportunity to collect...
Oct 20, 2022 The potential for unintended consequences in the Inflation Reduction Act By Jim Greenwood Alex Pinson Jamie Gregorian The Inflation Reduction Act (IRA) significantly impacts the US economic model for prescription drug innovation through the imposition of...
Oct 19, 2022 EU Pharma & Medical Device Regulation 2023 By Marco de Morpurgo Nicola Landolfi Our EU Life Sciences Regulatory team led by Marco de Morpurgo and Nicola Landolfi have produced a guide on EU Pharma & Medical Device...
Oct 12, 2022 The latest legislative changes in the pharmaceutical industry in Poland By Andrzej Balicki, Ph.D. Jolanta Dabrowicz Urszula Grębowska In our latest report, we provide an update on the key legislative changes proposed and introduced in the pharmaceutical sector in Poland.