Japan Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) concluded FY 2024‑25 (April 2024–March 2025) with a total of 148 approval decisions, including no less than 66 new active ingredients and 82 lifecycle updates, including new indications, pediatric expansions, and formulation changes. Innovation Snapshot A steady stream of orphan and rare‑disease designations—including sparsentan for primary…

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…

China Chinese biotech is booming, led by a generation of pioneering individuals at the forefront of science and business.   A country once best known as a low-cost manufacturing destination for ‘me-too’ copycat medicines now accounts for over 28 percent of the global drug development pipeline. Western companies approaching patent cliffs…

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…

USA The latest stories from healthcare and the life sciences in the US. The FDA names Stanford’s George Tidmarsh as the new head of CDER; AstraZeneca commits USD 50 billion to new US manufacturing and R&D projects; Moderna cancels its planned mRNA facility in Japan; Sarepta refuses to halt Elevidys shipments…

Puerto Rico In cell and gene therapy, where R&D and manufacturing are inseparable, Puerto Rico’s strong biopharma base makes it an attractive option for CGT companies.   The first mover in this space is CytoImmune. Founded in 2017 by a cadre of Big Pharma veterans and established in Puerto Rico in 2020,…

Puerto Rico Despite being a small island in the Caribbean, measuring just 100 by 35 miles, Puerto Rico has long punched above its weight as an industrial powerhouse. Already a leading producer of everything from blockbuster medicines to high-tech medical devices, how has it got to this point and what comes next?…

Puerto Rico Spending almost 30 years working for a single company is almost unheard of in today’s life science industry, where executives chop and change between firms with bewildering frequency.   However, in CooperVision – one of the world’s leading soft contact lens manufacturers with Puerto Rico at its beating heart –…

Puerto Rico The largest pharmaceutical hub in the Americas, Puerto Rico currently exports to 120 countries, accounting for nearly USD 53 billion in weekly biopharma shipments. Remarkably, this small Caribbean island out-exports all individual US states, shipping out over twice as much as second-placed Indiana. The life sciences industry is central to this…

Puerto Rico Long celebrated for its world-class pharmaceutical and medical device manufacturing, Puerto Rico is now leveraging this strong foundation to nurture a new era of research and development. Rather than shifting away from production, the island is integrating R&D directly into its manufacturing operations — from pilot plants and small-scale prototyping…

Puerto Rico Can Puerto Rico capitalise on the Trump administration’s “make in America” push?   President Donald Trump wants to bring manufacturing back to America. The last 40 years of globalisation and free trade saw huge chunks of the US supply chain for all kinds of goods, including essential medicines and medical…

Puerto Rico With over 80,000 people directly and indirectly employed in Puerto Rico’s biosciences sector, the island relies heavily on a skilled and stable workforce to maintain its competitive edge. But it faces a tough talent landscape: the median age of the local workforce is rising, and post-hurricane migration, combined with global…