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Brazil Brazil’s pharmaceutical sector is undergoing a quiet but significant transformation. Once dominated by multinationals and focused largely on generics, a group of leading domestic players is now charting a different course, towards innovation, manufacturing sovereignty, and strategic influence. Speaking on behalf of Grupo FarmaBrasil, a coalition of the country’s top…

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 Cell and gene therapies are redefining the boundaries of what is scientifically and operationally possible in healthcare, but bringing these innovations to patients at scale requires more than breakthrough science. In this conversation, Ralf Altenburger, Global Head of Cell & Gene Therapy at Roche, discusses how the company is navigating…

LatAm Yaneth Giha, Executive Director of FIFARMA, has transformed the organisation from a traditional trade association into a strategic platform for advancing healthcare access in Latin America. The first woman to lead FIFARMA, she drives evidence-based solutions, multi-stakeholder collaboration, and regulatory reform, positioning the region as a rising force in global…

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…

Denmark As European biotech continues to navigate tightening capital markets and increasing global competition, Kurma Partners is doubling down on its core belief: that world-class innovation can, and should, be built and scaled from within Europe. Managing Partner Rémi Droller shares how Kurma’s investment model combines early-stage company creation with long-term…

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…

China Dr Ben Zhao, Chief Executive Officer and co-founder of Haichang Biotechnology (HCBio, Haichang), represents a new paradigm in pharmaceutical innovation, bridging regulatory expertise with entrepreneurial vision. Having transitioned from a distinguished career at the FDA to establishing one of the most promising lipid nanoparticle delivery platforms in the industry, he…

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?…