Europe Last year the European Commission (EC) came out with a proposal to reform the EU’s core pharmaceutical legislation, aiming to address affordability, accessibility, and availability, among other objectives. One of the key changes proposed was reducing the EU’s baseline regulatory data protection (RDP) timeline, a plan that pleased the generics…
Europe Vikas Krishan, chief digital business officer at the global data and digital engineering solutions firm Altimetrik, outlines the implications of the European Union’s forthcoming AI Act for the pharma industry and urges for the need to adopt a proactive approach in evaluating AI roadmaps and governance. The pharmaceutical industry’s…
Europe Contributing to the August 2024 edition of DIA’s Global Forum magazine, Magda Chlebus from the EFPIA, Steffen Thirstrup and Alberto Ganan Jimenez from the EMA, Katharina Nothelfer of AiCuris Anti-infective Cures, Pedro Franco of Merck Serono, Annette Bakker of CTF Europe, Tim Chesworth of AstraZeneca, Jeevan Virk of Novartis, Virginie…
Global DIA’s Sorcha McCrohan, contributing to the the August 2024 edition of DIA’s Global Forum magazine, reviews insights from the town hall meetings that brought together regulators from around the world at the organization’s Global Annual Meeting 2024. Regulators worldwide recently convened in San Diego for DIA’s Global Annual Meeting 2024 to…
Switzerland Switzerland, home to industry giants like Novartis and Roche, boasts a thriving pharma industry that generates some seven percent of the country’s GDP, as well as a flourishing biotech scene. However, all is not so well in Switzerland’s domestic healthcare landscape, where surging insurance premiums and drug costs mean that…
United Kingdom The newly elected UK government’s Secretary of State for Health and Social Care Wes Streeting has a full plate of challenges ahead. Britain’s National Health Service (NHS) is plagued with a chronic lack of funding, staffing crunches and backlogs, while the country’s life sciences sector is seemingly in decline. Streeting…
Spain Some of the biggest stories coming out of Spain’s pharma industry, including Brookfield’s bid for a troubled Grifols; Esteve’s Spanish plant expansion; Rovi’s offers for a potential buyout of its CDMO business, and the EUR 90 million earmarked by Spain’s Ministry of Science, Innovation and Universities (MICIU) to promote biomedical…
Europe As the EU’s push to harmonise clinical assessments across its 27 member states moves from the initial Health Technology Assessment (HTA) regulation in 2022 to the European Joint Clinical Assessment (JCA) process that will come into effect in January, European HTA authorities and industry leaders weigh in on the implications.…
Europe Physician and pharma industry veteran Iris Zemzoum is returning to Europe after leading Novartis Asia Pacific, Middle East and Africa through the COVID-19 pandemic. As Novartis looks to further hone in on innovation after spinning-off generics and biosimilars division Sandoz, Zemzoum will face a unique set of challenges in her…
Europe Writing in DIA’s Global Forum magazine for June 2024, the organization’s Vedran Raguz reviews some of the key takeaways from DIA Europe 2024, namely the need for increased collaboration, alignment and harmonization among international regulatory bodies and stakeholders. One of the overarching themes of DIA Europe 2024 was the imperative of…
Switzerland The latest news from Swiss pharma and biotech including a new CEO appointment for leading CDMO Lonza, promising Phase III readouts from Novartis’ latest leukaemia drug at ASCO, Roche’s pivot to obesity, and why the Swiss industry is betting big on artificial intelligence. Lonza appoints Wolfgang Wienand as new…
Spain A roundup of the biggest stories emerging from Spain’s pharma industry: Grifols pushes to improve governance after accusations of overstated earnings; Rovi and Insud join forces to create Spain’s first semi-public pharmaceutical company; Almirall and Eloxx Pharmaceuticals sign a licensing agreement for a rare dermatological disease asset, and Esteve acquires…
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