Europe The EMA’s Pre-Accession Assistance Program (IPA) helps EU candidate and potential candidate countries align their medicines regulations with EU standards through training, capacity-building, and policy support. As a new op-ed in the February 2025 edition of DIA’s Global Forum magazine outlines, an impact assessment of IPA II (2020-2023) showed significant…
Denmark As tensions rise over US-EU trade, will the weight-loss drug Ozempic become an unexpected bargaining chip? Stan Jackson explores the risks of leveraging GLP-1s in economic negotiations. You can always tell when a blockbuster drug has entered the cultural zeitgeist. It’s around the time you start to hear the…
Japan After 12 years at the helm, Takeda CEO Christophe Weber is stepping down, leaving behind a transformed company. Under his leadership, Japan’s biggest drugmaker expanded globally with the $62 billion acquisition of Shire, made waves with its dengue vaccine QDENGA, navigated the loss of exclusivity on its ADHD blockbuster, and…
Global The 2025 Davos World Economic Forum brought together business leaders from multiple industries to debate the challenges and issues facing the world today. The Pharma CEOs in attendance discussed critical topics such as the impact of climate change on health, AI-driven innovation, and the complexities of global trade tensions, all…
Global In an era of rapid scientific breakthroughs, global regulators are navigating new challenges—accelerating approvals, harmonising standards, and integrating digital tools—while balancing safety, efficacy, and access. Throughout 2024, PharmaBoardroom spoke with regulators worldwide to uncover the key regulatory trends shaping the future of healthcare in 2025 and beyond. The Road…
Europe The European Brain Council (EBC) is a key player in advancing brain health research and policy across Europe, bringing together diverse voices to address the pressing issues of neurological and mental health. As Frédéric Destrebecq, the EBC’s Executive Director, explains, “We must restore the trust between science and society for…
Brazil A roundup of the biggest stories from Brazil’s pharma industry, including Teuto’s cannabis manufacturing deal with MediPharm; Eurofarma’s AI-based epilepsy joint venture with SK Biopharmaceuticals; EMS’s increased stake in Hypera after a failed merger attempt, and Quantoom, Univercells and Fiocruz’s RNA-based vaccine production collaboration. MediPharm Labs Enters Landmark Commercial…
Europe James Riddle of Advarra, writing in the January 2025 edition of DIA’s Global Forum magazine, looks at how the EU’s AI Regulation will impact clinical trials in Europe. In an era where artificial intelligence (AI) is revolutionizing healthcare and clinical research, regulatory bodies are racing to keep pace. The…
Global In 2024, global biopharma faced a challenging landscape shaped by geopolitical tensions and cost containment measures in key markets. Despite these pressures, most major players perhaps surprisingly opted to retain their CEOs, focusing instead on reshaping management at other levels. Companies like Bayer underwent sweeping transformations, while others, such as…
France François Bayrou’s new administration in France, sworn in after the previous, three-month-old government was toppled by a no-confidence vote, brings a new health minister to a post recently characterized by instability. With budget concerns looming and the doubtful staying power of the new cabinet, it remains to be seen how…
USA While the year’s tally of green lights from the FDA’s Center for Drug Evaluation and Research (CDER) is lower than the previous year’s, 2024 saw several long-awaited therapies reach the finish line. Oncology remained the single largest focus area among last year’s endorsed therapies and as opposed to 2023 when…
Global With a record number of recent approvals representing game-changing potential for conditions like sickle cell disease, a significant number of advanced therapies making progress in the clinic, and an uptick in investment, cell and gene therapies are set to continue making considerable headway in 2025. Yet their elevated price tag…
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