Tagged with Europe,

Switzerland With over seven decades of innovation behind it, Lupin has evolved from an Indian pioneer in anti-tuberculosis therapies into a global pharmaceutical leader shaping the future of complex generics, speciality care, and biosimilars. As the company accelerates its European expansion, Laurent Renaudie shares how Lupin’s entrepreneurial culture, patient-centred mission, and…

Europe Affordability is not necessarily the main barrier to better rare disease therapy access in Europe. Across the continent, orphan availability correlates poorly with GDP per capita, but strongly with health technology assessment methods, speed of pricing and reimbursement, and central vs regional decision-making. Better system design – rather than simply…

Switzerland Giancarlo Benelli, SVP, Head of Europe at BeOne Medicines (BeOne), draws on nearly three decades of pharmaceutical leadership to drive the company’s rapid growth in oncology and haematology in Europe, with flagship assets like zanubrutinib and tislelizumab. Over the last few years, BeOne has greatly expanded its clinical trials in…

Europe Rainer Westermann of European life science venture capital lobby group, the Life Sciences Acceleration Alliance, lays out a policy roadmap for how innovative European pharma can continue to grow and thrive against a backdrop of trade uncertainty and precarious US-EU relations.   The US/EU trade deal was presented as necessary…

Europe Europe has a plasma problem. The continent is over-reliant on the US for plasma – donated, purified human blood liquid – which is a key component in several lifesaving drugs for immunity, bleeding, critical care, and rare disorders.   The Donor Dilemma One explanation for these shortages is the lack…

Europe Advanced Therapy Medicinal Products (ATMPs) – encompassing gene therapies, somatic-cell therapies, and tissue-engineered products – have been regulated in the European Union under a dedicated framework since 2009. As of 2025, the European Medicines Agency (EMA) has authorised close to 20 ATMPs (below), most of them gene therapies for rare…

Europe The EU’s Health Technology Assessment Regulation (HTAR), which kicked off in January 2025, has launched joint clinical assessments (JCAs) for oncology and advanced therapies; yet six months in, implementation remains rocky, communication is patchy, and the wider impact on access and innovation is still murky. Writing in DIA’s Global Forum…

Switzerland 2024 marked a transformative year for Switzerland’s regulatory authority, Swissmedic. As part of its ambitious 2023–2026 strategy, the agency made significant strides towards digital transformation and improving access to innovative medicines while delivering a notable 12 percent increase in new drug approvals with 46 new active substances. Drive for Digital…

Denmark At first glance, Denmark might seem an unlikely hub for pharmaceutical production. With its small size and some of the highest labour costs in Europe, manufacturers might decide to look elsewhere. Yet major global players like Fujifilm Biotechnologies and AGC Biologics are doubling down on their Danish investments, expanding facilities…

Global Whether in the corridors of the FDA or the fast-evolving frameworks of ANVISA in Brazil, regulators around the world are undergoing a quiet revolution. While mature markets like the US and Europe double down on digitalisation and real-world evidence, emerging players like Brazil and China are accelerating access and joining…

Global As the global population ages and the incidence of vision-related conditions rises, ophthalmology is entering a transformative era. Beyond symptom management, the field is moving towards disease modification through cell and gene therapies like optogenetics while boosting artificial intelligence (AI) to speed up pipelines, and developing minimally invasive delivery systems…

Europe Pharma and biotech companies are doubling down on innovation and, often, outsourcing just about everything else. That shift has turned contract development and manufacturing organisations (CDMOs) into critical partners, not just service providers. The sector is booming, but pressure is building fast: demand is surging, capacity is stretched, and new…