Tagged with Medicines

Belgium Belgium, one of Europe’s most important countries for biopharmaceutical production and R&D, assumed presidency of the Council of the European Union on the first of January. As part of its Presidency Programme, Belgium has highlighted health as one of its 14 focus areas, with the hope of strengthening the three…

Europe The European Union’s just-released and first essential medicines list is the latest in a series of measures designed to limit the bloc’s reliance on countries outside its borders and avoid drug shortages. As Elisabeth Stampa of generic and biosimilar lobby group Medicines for Europe recently explained to PharmaBoardroom, this is…

Europe The COVID-19 pandemic and subsequent shortages of essential medicines and APIs laid bare Europe’s reliance on suppliers outside its borders. To combat this issue and ensure that Europe is better prepared for future health crises, the Spanish Presidency of the EU is advocating for a focus on ‘strategic autonomy’ up…

Europe Pfizer’s David Isom and Monica Mihedji, writing in the November 2023 edition of the DIA’s Global Forum magazine, examine how the European Medicines Agency is attempting to integrate the use of artificial intelligence in its regulatory work.   Regulators are advancing information technology and data modernization initiatives to drive more…

Africa Writing in the July 2023 edition of DIA’s Global Forum magazine, Nevena Miletic of Roche and the IFPMA’s Africa Regulatory Network and Ian Hudson from the Bill and Melinda Gates Foundation look back on the progress made towards instituting an African Medicines Agency and the next steps in this important…

Europe As part of a wide-ranging conversation with PharmaBoardroom published earlier this month, European Medicines Agency (EMA) Executive Director Emer Cooke laid out four of the Agency’s core focus areas for the coming year, including the lessons to be taken from the pandemic response, why antimicrobial resistance must not be neglected,…

Europe As part of the EU’s Pharmaceutical Strategy for Europe, the European Commission has come out with a set of proposals to revise EU pharmaceutical legislation. The reforms, which aim to make medicines more available and accessible across Europe by reducing regulatory exclusivity, speeding up review processes and reinforcing supply chains…

Europe In conversation at DIA Europe 2023 in Basel, European Medicines Agency Executive Director Emer Cooke looks back at the lessons EMA has taken from the COVID-19 pandemic response, outlines the Agency’s approach to antimicrobial resistance, and highlights how it hopes to contribute to a stronger European clinical trials ecosystem.  …

Europe The European Medicines Agency (EMA) recently published its annual Human Medicines Highlights report, documenting key figures on its recommendations for the authorisation of new medicines in 2022. The Agency gave 89 positive opinions last year and recommended the authorisation of 41 new active substances. See below for a full list.…

Greece Speaking shortly after the unveiling of a EUR 55 million investment in a new factory in Keratea as part of a wider EUR 155 million spend up to 2025, ELPEN’s Theodore Tryfon outlines the company’s ambitious expansion and diversification plans; his hopes for the future of essential medicine manufacturing in…

Global During the COVID-19 pandemic discussions around increasing access to medicines for low and middle-income countries (LMICs) were often centred on compulsory licensing. As a result, pharma companies were up in arms about protecting the intellectual property (IP) of their innovative medicines. But there is an alternative, says Charles Gore from…

Global The Medicines Patent Pool (MPP) is a United Nations-backed public health organisation working to increase access to, and facilitate the development of, life-saving medicines for low- and middle-income countries. Executive Director Charles Gore outlines the MPP’s goals, how it interacts with an industry – innovative pharma – known to jealously…