Tagged with European

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 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…

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…

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.…

Europe Based on current discussions by the European Commission, launch conditionalities would not account for the distinct nature of small and mid-sized companies, OMPs and ATMPs. EUCOPE’s Alexander Natz breaks down this aspect of the revision of the general pharmaceutical legislation and why it would prove unsustainable for smaller companies and…

Europe The EU biopharmaceutical ecosystem is currently languishing in third place globally. EUCOPE’s Alexander Natz discusses how the European Commission’s most fundamental review of the pharmaceutical legislation in decades is supposed to change that but in reality, is discouraging innovation and competitiveness.   The European Commission’s ambition to future-proof the EU…

Europe Pierre Meulien, Executive Director- Innovative Health Initiative, presents the public-private joint undertaking that boasts a total budget of EUR 2.4 billion and aims to build on the work of the Innovative Medicines Initiative to boost collaboration between the European pharmaceutical and related industries and the European Commission.   The Innovative…

Spain AseBio is the association promoting the development of the Spanish biotechnology industry. Its general manager, Ion Arocena, lays out the main priorities for the country’s sector, including the need to reevaluate public funding mechanisms at a national and European level, and provides an explanation for Spain’s leadership in clinical trials…

Europe A roundup of the latest news from European biotech, including BioNTech and CureVac’s German vaccine manufacturing deal; the revival of Valneva’s plans to manufacture its vaccine in Scotland; and Morphosys’ shuttering of its US R&D footprint.   BioNTech, CureVac part of $3.14B deal to bolster German vaccine capacity through 2029:…