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…
Europe The Women’s Brain Foundation, formerly the Women’s Brain Project, has evolved into a fully-fledged foundation dedicated to advancing research in gender precision medicine with a strong focus on brain health. CEO pro-bono Dr Antonella Santuccione Chadha comments on the organisation’s newly extended global reach, progress in understanding the link between…
CEE A roundup of some of the top news coming out of the Central and Eastern European (CEE) region’s pharma industry, including Poland’s first draft of a national critical medicines list; Polpharma’s acquistion of the dermatological firm Ziołolek; Sopharma’s sale of its logistics unit, Farmalogistika; Horus Pharma’s significant stake in Romania’s…
Europe Jazz Pharmaceuticals is about to open a new chapter in its history. As long-standing CEO and co-founder Bruce Cozadd prepares to step down for retirement, the neuroscience and oncology-focused company begins its search for a new leader and gets ready to commercialize recently FDA-approved HER2-targeted bispecific antibody, Ziihera. End…
Switzerland Switzerland’s healthcare system is globally renowned. It leads the world on metrics such as infrastructure, medical advances, and patient freedom to choose healthcare services, and ranks 1st in US thinktank FREOPP’s 2022 World Index of Healthcare Innovation. However, it lags in one key area: digitalisation. On that front, Switzerland has…
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