Tagged with US

Asia-Pacific Writing in the June edition of DIA’s Global Forum magazine, Ellen Sem, Fengyun (Vicky) Han and Annetta C. Beauregard from Janssen Pharmaceutical Companies of Johnson & Johnson, outline the real-world data (RWD) and real-world evidence (RWE) regulatory landscape in Asia Pacific.  Real-world data (RWD) and real-world evidence (RWE) have played an…

Global The COVID-19 pandemic brought the issue of access to medicines to the forefront. Not only did supply chain disruptions lead to initiatives designed to make sure essential medicines reach patients, but the pandemic also served to underline a number of pre-existing access inequalities. Several of PharmaBoardroom’s recent interviewees have discussed…

Australia Pharmaceutical policy issues played a major role in Australia’s recent national election. Shawview Consulting’s Brendan Shaw outlines the medicines issues that came under scrutiny during the campaign. It was the first national election since the start of the COVID-19 pandemic, and it resulted in an historic change of government. The…

Asia-Pacific We spoke to Dr Sarthak Das, Chief Executive Officer of the Asia Pacific Leaders Malaria Alliance (APLMA), about the region’s progress towards malaria eradication and the organisation’s priorities, now that its target date for a malaria-free Asia Pacific is just eight years away. … if you compare [malaria] to other…

USA Longtime Director of the Center for Drug Evaluation and Research CDER, Janet Woodcock, will be changing roles at the US Food & Drug Administration (FDA) and moving away from drug regulating. It is still unclear what her new role will entail. Rob Califf, the new FDA commissioner recently announced in…

USA In the United States, clinical trials have long been criticized for inadequate inclusion of minority patients and consequently for not representing the country’s diverse population. The FDA recently released new guidance for improving diversity in clinical trials. According to its Drug Trials Snapshots Report for 2019, of the clinical trials…

Sweden Anders Blanck, CEO of LIF, the industry organisation for the research-based pharmaceutical industry in Sweden, describes the Sustainability Strategy that the pharma industry in Sweden is now launching. Central to the Strategy is a Manifesto with nine commitments that covers the entire value chain of medicines – from research and…

USA The pandemic revealed widespread pharmaceutical supply chain vulnerabilities in the United States, an issue the Biden administration has attempted to address partly through industry funding. The Chief Business Officer of Phlow, a company that has received federal government funding for manufacturing essential medicines in the US, spoke at the recent…

United Kingdom Just one year after the UK government published its Life Science Vision, outlining the ambitions of the government and the life science sector for the next 10 years, the Association of the British Pharmaceutical Industry (ABPI) has appointed a new president who will take on the plan.  The Association of…

Olympus Olympus is a 100-year-old technology company that has revolutionised the world of cameras since 1919, and recently underwent a transformation shifting its focus entirely to MedTech. Ronald Boueri, Regional Division Manager for Middle East and Africa region sheds light on the company presence regionally, as well as efforts to position…

USA Stephen J. Ubl, President & CEO of Pharmaceutical Research and Manufacturers of America (PhRMA) discusses the organisation’s initiatives to address health inequity in the US along with its opposition to the provisions in the Biden administration’s Build Back Better Act to lower costs and improve access. He also comments on…

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…