Tagged with EMA

Europe In an extensive recent PharmaBoardroom conversation, EMA Head of Advanced Therapies Ana-Hidalgo-Simon highlighted some of the most important trends around advanced therapy regulation in Europe. Hidalgo-Simon touched on why moderate growth in regulatory applications is a positive development for the EMA, how patient insights are being better incorporated into the…

Europe Speaking exclusively to PharmaBoardroom, the EMA’s Head of Advanced Therapies Ana Hidalgo-Simon discusses steadily growing numbers of regulatory applications in the advanced therapy field, the vital importance of patient group insights, RWE collection and curation, hospital exemptions, manufacturing challenges, and more.   [Advanced] therapies are complex, difficult, and have a…

USA Pfizer and MSD recently became the latest companies to have COVID-19 treatments authorised by either the US FDA or EMA. Their oral antiviral drugs joined several monoclonal antibodies and others on the list of options available to patients in Europe and the United States. Here is an updated list of…

Denmark Denmark has long been at the vanguard of digitalisation, most notably in the form of comprehensive national health registries. This well-established footprint gave the Nordic nation a headstart in battling the COVID-19 pandemic in 2020 and beyond and can be accredited with Denmark’s relatively successful identification, testing, and vaccination processes.…

Denmark Henrik Jespersen introduces software and systems provider Systematic’s work in the healthcare space, where the Danish firm looks to help provide a continuum of care across the entire system. Jespersen outlines why it makes sense for Systematic to work alongside other solution providers if requested by its clients, how the…

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…

Singapore Annie Tan highlights the strategy she laid out to navigate the BMS Singapore, Thailand and Malaysia affiliates through the COVID-19 pandemic; the opportunities and challenges of integrating the Celgene portfolio into local BMS operations; and her aim to build the company into an oncology and haematology powerhouse in Southeast Asia…

Europe The full list of medicines recommended for approval by the European Medicines Agency (EMA) in 2020 divided by therapeutic area and with drugs that contained a new active substance highlighted in bold. The EMA approved a raft of new oncology medicines in 2020, as well as new treatments in haematology/…

Global While great strides in gender diversity has been made within healthcare boardrooms and leadership teams globally, as well as more generally across the workplace and many other arenas in many countries, at times we are served a stark reminder that the fight for greater gender equality and women representation is…

Global 2020 was a challenging year globally, but one in which the importance of the healthcare and life sciences sector was underlined like never before. Despite lockdowns and travel restrictions, PharmaBoardroom still managed to talk to key industry stakeholders from across the world helping shape the future of global health. Featured…

Europe The EMA’s Head of Advanced Therapies Dr Ana Hidalgo-Simon outlines Europe’s evolving regulatory framework for regenerative medicines, how it differs from those in the USA and Asia, ethical and pricing challenges, and why global regulatory harmonization and collaboration is crucial.   For advanced therapies, market approval is not the end…

Europe The European Medicines Agency (EMA), Europe’s regulatory body for medicines, has nominated Irish candidate Emer Cooke to as its new executive director at a crucial time for the agency as its powers and priorities shift in the wake of the COVID-19 crisis.   If Cooke accepts and gives an official…