USA When the FDA gave Novartis the historic green light for Kymriah – the first gene therapy approved in the United States – in 2017, the agency declared that it was “ushering in a new approach” to the treatment of cancer and other serious and life-threatening diseases. Today, more than 20…
Australia Writing in April edition of DIA’s Global Forum magazine, the University of New South Wales’s Richard Day looks at Australia’s National Medicines Policy (NMP) and how it is being reshaped by community and stakeholder feedback. Australia’s National Medicines Policy (NMP), gazetted in 2000, is being revised and the draft policy was…
South Korea Chair & Founder, Regenerative Medicine Acceleration Foundation (RMAF), So Ra Park MD, PhD*, comments on the regenerative medicine ecosystem in Korea, the country’s new legislative approach to the field, and the Korean market’s strong potential for growth in Asia. The first approval of a regenerative medicine product in Korea…
Spain The Vall d’Hebron Institute of Oncology (VHIO) is a Barcelona-based institute dedicated to delivering on the promise of precision medicine in oncology – turning cancer discovery into more effective treatments and better practice for the care of patients. Its director, Dr Josep Tabernero, talks about VHIO’s four main lines of…
Spain EATRIS, the European Infrastructure for Translational Medicine, is an EU-funded program that facilitates scientific collaboration amongst public institutions from 14 member states. Its scientific director, Dr Toni Andreu, explains how the organisation coordinates a network that helps European researchers access public facilities in other countries. A former general director of…
Global Shawview Consulting’s Brendan Shaw examines the WHO’s recently released updated Essential Medicines List. Shaw highlights some of the key trends and new inclusions in the List, why pricing and transparency are hotter topics than ever, and how pharma can incorporate this important document and its implications into their strategies for…
Denmark Established in 2017, the Danish Medicines Council is the health technology assessment (HTA)-like body in Denmark which assesses the value for patients and costs to society of new medicines. The Medicines Council then makes recommendations to the Danish Medicines Agency (the country’s regulator) and Amgros (the national public procurement body).…
Denmark Jørgen Schøler Kristensen explains the role of the Danish Medicines Council, providing guidance about new medicines for use in the Danish hospital sector. Kristensen also tackles the thorny issues of price considerations, assessing the long-term efficacy of innovative new therapies, and working collaboratively with private industry. There is a…
Global Over the past 12 months, PharmaBoardroom has spoken to the heads of several key regulatory bodies across the world. While the approval processes for COVID-19 vaccines have evidently been top of their priority lists, other key topics discussed included the potential of data and AI to change the drug approval…
Denmark In a wide-ranging interview, incoming director general of the Danish Medicines Agency Lars Bo Nielsen discusses the challenges that personalised medicine presents to regulators, building a stronger international presence for the Agency, and better leveraging the country’s world-class data infrastructure while respecting the EU’s data protection regulation. Within Europe,…
Switzerland A. Vogel CEO Dr Andy Suter outlines the Swiss herbal medicine market leader’s expansion in recent years, why it is prioritising R&D more than ever, and how the COVID-19 pandemic has created a renewed focus on phytopharmaceuticals and preventive medicine. There is a segment of people looking to take…
China Anticancer Bioscience is an exciting international precision oncology company, applying synthetic lethal approaches to develop targeted cancer therapies. President & CEO Dun Yang explains the company’s origins, how ACB’s approach differs from that of its competitors, and how he plans to make the firm into “China’s Genentech.” We want…
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