Tagged with OP

Global Patents can be an excellent way to demonstrate value, not only showing that a technology is protected but also how promising it can be when it eventually comes to market. Here, William Mansfield of LexisNexis® Intellectual Property Solutions outlines how ‘patent analytics’ can help identify pharma’s top performers today as…

Brazil The DIA Global Annual Meeting 2023 hosted DIA’s first regulatory Town Hall fully dedicated to one regulator from Latin America, as leadership from Brazil’s Health Regulatory Agency, ANVISA, shared updates on the country’s regulatory priorities, the agency’s strategic priorities, and local trends, as well as ongoing regulatory convergence and collaboration initiatives. This…

China Writing in the September 2023 edition of DIA’s Global Forum magazine, Shuting Li of Anhui Jimin Cancer Hospital and Xinfang Fan of Bayer Health Care Ltd. examine how Chinese clinical trials are increasingly focusing on patient engagement and patient centricity.   In recent years, with the Chinese government’s vigorous support…

Global Amgen has forged a solid position as one of the world’s largest independent biotechnology companies. With a market capitalisation of some USD 130 billion and 27 approved medicines, the US-based firm has come a long way from its original biotech upstart status in 1980. Nonetheless, Amgen has faced obstacles in…

Europe The European Coalition for Access to Comprehensive Genomic Profiling (ECGP) is a new initiative made up of industry association the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), molecular diagnostics firms Exact Sciences and Guardant Health, sequencing platform provider Illumina, and drugmakers MSD and Novartis. Here, the coalition lays out its aims…

Global The rise of niche therapies is shaping a more tailored engagement model, driven by data and AI, writes Florian Schnappauf, vice president of enterprise commercial strategy at Veeva Europe.   Last year, orphan drugs accounted for more than a third of Europe’s new drug approvals, and the number of gene…

USA With office occupation rates on the slide and the life sciences industry’s demand for lab space on the rise, the repurposing of existing offices into medical laboratories has become an important new asset class, writes Liz Chen, a lab planner at HGA Life Science + Advanced Technology Group’s San Diego…

China Established in 2017 as a spin-off from Lee’s Pharmaceutical, Zhaoke Ophthalmology is aiming to be a global player in the ophthalmology field, building on its strong footprint in China and Asia to eventually establish operations in the US and Europe. President and Chief Scientific Officer Lau Lit Fui outlines how…

Germany Following the COVID-19 pandemic and the resulting supply chain disruptions, global drug pricing and access reforms have multiplied. The Inflation Reduction Act (IRA) has been introduced in the US while the European Commission is looking at a major overhaul of the EU’s pharmaceutical regulations. Germany, in light of the growing…

Americas Writing in the August edition of DIA’s Global Forum magazine, Silvia B. Bendiner of WESSX Inc. and Belkis Romeu call for greater regulatory collaboration between Latin American countries, building on an initiative created by Dr. Rafael Pérez Cristiá at the Cuban Regulatory Authority (CECMED).   The need for further regulatory…

China Writing in the August edition of DIA’s Global Forum magazine, Wen Yin of the Pfizer China R&D Center and Wanhe Deng of GSK China Investment look back on four years of China’s marketing authorization holder (MAH)-based regulatory system, including the opportunities it presents, and some of the implementation challenges.  …

Europe Rainer Westermann, chairman of the Life Sciences Acceleration Alliance e.V. (LSAA), which lobbies on behalf of European venture capitalists in the life sciences space, critiques the draft EU Pharma Regulation from a VC perspective, arguing that the continent’s status as a medical innovation hub is at risk if the EU…