Tagged with USA,

Global A wave of blockbuster biologics is set to lose patent protection, creating a major inflection point for the biosimilars market in 2025 and beyond. While Europe remains the global leader in biosimilar adoption, South Korea is rapidly emerging as a powerhouse, leveraging strong government support and industry investment. However, a…

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…

Puerto Rico Antonio Medina, CEO of Convergent Strategies, shares insights into Puerto Rico’s evolving economic landscape and the critical role his consultancy plays in driving growth and innovation across industries. He reflects on his experience guiding the island out of bankruptcy as a member of the Financial Oversight Board and discusses key…

Global Regular PharmaBoardroom contributor David H. Crean outlines the resilient and cautious optimism observed at JPM 2025, the annual healthcare financing conference held near San Francisco’s Union Square. While uncertainties and headwinds still persist, particularly around regulatory changes, affordability issues, and capital financing in the public and private markets, the healthcare…

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…

Global Regular contributor Brendan Shaw looks ahead to a potentially turbulent 2025 for the pharmaceutical industry, highlighting five key trends that industry stakeholders must carefully navigate over the coming 12 months.   As pharma companies gear up for another year – a year that marks a quarter of the way through…

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…

USA The Biosecure Act has been excluded from a recent key defense spending bill, leaving its future unclear. But whether or not it ends up being passed, the legislation has already proved detrimental for the targeted Chinese companies and the new Trump administration’s “America first” stance may have other adverse effects…

Puerto Rico Long recognized for its strengths in manufacturing and distribution, Puerto Rico is looking to capitalize on its positive attributes and position itself as a centre for innovation. While important tax incentives have provided stimulus for R&D, the US territory is also working on building a strong local ecosystem, developing and…

USA For those concerned that opinion and not science may determine US public health policy under president-elect Trump, the choice of surgeon Martin Makary as head of the FDA may be reassuring. While Makary is known as a healthcare critic, his views appear to be far less extreme than the controversial…