Tagged with Medicine

Africa Medicines for Africa’s Lenias Hwenda argues that the success of the much-talked-about African Medicines Agency hinges on a critical mass of African national regulators achieving WHO Level 3 maturity status. While acknowledging the importance of international actors in making this happen, Hwenda argues that – if the African Medicines Agency…

Europe The EMA’s Peter Arlett looks back on two years of the Accelerating Clinical Trials in the European Union (ACT EU) initiative which aims to improve the environment for clinical trials in the EU by transforming how trials are initiated, designed, and run. In conversation following DIA Europe 2024 in Brussels,…

Europe PharmaBoardroom was delighted to attend DIA Europe 2024 in Brussels earlier this month, bringing together a veritable who’s-who of the European and global regulatory community. The politicians, regulators, payers, patient advocates, industry representatives, and service providers in attendance were treated to a three-day buffet of engaging panels and townhalls with…

Europe The European Medicines Agency (EMA) recommended 77 drugs for marketing authorisation in 2023, including 39 new active substances, coming up behind the FDA’s record 55 new drug approvals last year. Cancer led the roster of EMA green lights with 25 authorisations, including nine therapies the agency has discerned as major…

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…

Portugal Portugal boasts a well-developed universal healthcare system and saw healthcare spending increase by 6.2 percent annually between 2016 and 2021, according to the OECD. However, the representatives of innovative medicines manufacturers embedded in the country are keen to point out that access to the latest drugs remains a big issue…

Portugal Speaking to PharmaBoardroom as Janseen is rebranding as Johnson & Johnson Innovative Medicine, managing director for Portugal, Filipa Mota e Costa, discusses the affiliate’s expanded local footprint and its ranking as the number one pharmaceutical company in the country. She also explains Portugal’s market access progress, including the consolidation of…

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…

Global New methodology for the 2024 Access to Medicine Index promises a stronger attempt to quantify whether drugs, vaccines, and diagnostics are actually making it all the way to patients in poorer countries around the world.   Industry stakeholders eagerly await the biennial publication of the Access to Medicine Index, a…

Europe The European Coalition for Access to Comprehensive Genomic Profiling (ECGP) is a new initiative made up of industry association the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), molecular diagnostics firms Exact Sciences and Guardant Health, sequencing platform provider Illumina, and drugmakers MSD and Novartis. Here, the coalition lays out its aims…