Japan The latest healthcare and pharma news from Japan, including Shionogi’s COVID-19 pill, the Japanese parliament’s green light for emergency approvals of drugs and vaccines and Hitachi’s partnership with Invivoscribe.   Shionogi’s COVID-19 pill  (Reuters) The future of Shionogi & Co Ltd’s experimental treatment, S-217622, is still uncertain. The company recently…

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…

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…

China Due in part to an increasingly encouraging regulatory environment, China continues to strive for progress in cell and gene therapies (CGT). In fact, according to a 2021 Nature study, CAR T-cell therapy clinical trials in China have accounted for over 50% of registered CGT studies worldwide. Currently, over 200 CAR-T…

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…

Global The pandemic era has demonstrated the value of innovation, from the mRNA vaccine breakthrough to the use of new technology. Speaking at the recent FT US Pharma and Biotech Summit Sanofi’s CEO Paul Hudson demonstrated that the company is not just riding the current wave but continuing to innovate on…

Taiwan The latest healthcare and pharma news from Taiwan, including the CDMO Bora Pharmaceutical’s acquisition of Eden Biologics assets, the FDA fast track granted to the Taiwanese biomedical group United Biomedical’s Vaxxinity and the Phase II clinical trials completion for a Taiwanese COVID treatment.   Bora consolidates its position in Taiwan’s…

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…

Americas After five years in China, Rogier Janssens goes on to lead Latin America Healthcare for EMD Serono. Rogier Janssens, former General Manager of the biopharma business of Merck KGaA, Darmstadt, Germany in China has been appointed Senior Vice President – Head of Latin America Healthcare for EMD Serono, taking over…

China Writing in the May edition of DIA’s Global Forum magazine, Xu Wang of Novo Nordisk China looks at the new drug approvals in China in 2021. Among other highlights, the approval of two CAR-T products signal that CAR-T treatment has finally entered the commercialization stage. The number of new drug…

Europe Nick Sykes of Pfizer discusses the European Commission’s intention to “future-proof” the EU regulatory system and the suggestions for changes that were discussed througout the DIA Europe 2022 meeting. From the May edition of DIA’s Global Forum magazine. In its Pharmaceutical Strategy, the European Commission intends to “future-proof” the EU…