Tagged with drug

USA The Pharmaceutical Research and Manufacturers of America (PhRMA) has had a board reshake, naming Gilead Sciences Chairman and CEO Daniel O’Day as its new chair. The reorganisation comes after the industry group’s failed efforts to block the Inflation Reduction Act (IRA) and the departure of several high-profile members.   Gilead…

Switzerland For the Swiss Agency for Therapeutic Products (Swissmedic), one of the world’s leading regulatory authorities, 2023 was an important year. Not only did the agency gain recognition from the World Health Organisation (WHO), Swissmedic also saw a Good Manufacturing Practice (GMP) agreement between Switzerland and the US FDA come into…

Europe The European Medicines Agency (EMA) recommended 77 drugs for marketing authorisation in 2023, including 39 new active substances, coming up behind the FDA’s record 55 new drug approvals last year. Cancer led the roster of EMA green lights with 25 authorisations, including nine therapies the agency has discerned as major…

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…

Hong Kong Generative Artificial Intelligence (AI) has grabbed a lot of media attention in recent months following the launch of chatbot ChatGPT, but the pharmaceutical industry has long been trying – and struggling – to better integrate AI into the long and failure-fraught drug discovery process. While AI-enabled drug discovery may not…

USA Big Pharma has been raging against the US’s Inflation Reduction Act (IRA) ever since it was passed last year. Merck (MSD global) has recently taken its indignation a step further and sued the US government, arguing that the new legislation violates the constitution, but shareholders at the ICCR are not…

USA After Big Pharma lobby groups suffered a major drug pricing blow earlier this year with the passage of the US Inflation Reduction Act (IRA), pharma industry heavyweight AbbVie is withdrawing its membership to leading industry trade groups PhRMA and BIO.   AbbVie Bows Out AbbVie is leaving both of the…

USA Clinical trial diversity not only allows for a better understanding of the safety and efficacy of new therapies in population subgroups but also plays a significant role in reducing health inequities. In conversation with PharmaBoardroom, outgoing president and global chief executive of the Drug Information Association (DIA) Barbara Lopez Kunz,…

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…

Italy SIFI’s Fabrizio Chines outlines how the company is progressing in European ophthalmic markets, explains the added value it is bringing to the glaucoma field, and tells us about its orphan drug for acanthamoeba keratitisis.    … Germany and the UK are the next strategic targets, but in those markets we will…

Singapore Writing in the December edition of DIA’s Global Forum magazine, Agnes Ho, Cindy Zen, and Tan Kwee Lan of Boehringer Ingelheim give an overview of the current regulatory framework for orphan drug registration in four ASEAN countries and what more could be done to improve it.   Regulatory authorities such…

Brazil The editorial team at Panorama Farmaceutico explain why coordinated action is needed within Brazilian pharma to reduce dependence on API imports from abroad and increase medical sovereignty. *   The COVID-19 pandemic has exposed the global pharmaceutical industry’s dependence on markets such as India, the source of about 20 percent…