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…
India In the latest blow to Indian pharma’s reputation, the European Medicines Agency (EMA) has recommended the suspension of marketing authorisations for a large number of generics tested by Indian CRO Synapse Labs. While the Indian government has taken steps to regulate the industry and improve quality, including a new Drugs,…
Morocco Lamia Tazi, chairwoman of the board and CEO of Sothema and VP of the Moroccan Federation of the Pharmaceutical Industry (FMIIP), walks us through the over 40-year-old family-owned Moroccan company’s heritage as well as some of its recent advances such as the launch of its own range of oncology treatments.…
Europe As part of a wide-ranging conversation with PharmaBoardroom published earlier this month, European Medicines Agency (EMA) Executive Director Emer Cooke laid out four of the Agency’s core focus areas for the coming year, including the lessons to be taken from the pandemic response, why antimicrobial resistance must not be neglected,…
Europe In conversation at DIA Europe 2023 in Basel, European Medicines Agency Executive Director Emer Cooke looks back at the lessons EMA has taken from the COVID-19 pandemic response, outlines the Agency’s approach to antimicrobial resistance, and highlights how it hopes to contribute to a stronger European clinical trials ecosystem. …
Egypt Dr Amel El Beshlawy, founder of Egyptian Thalassemia Association (ETA) and Professor of Pediatric Hematology at the Pediatric Hospital of Cairo University, is considered the Middle East’s leading authority on Thalassemia, having made an enduring contribution not only to improving the survival rate of thalassemia patients in her clinical practice,…
Global DIA 2022 convened with an opening plenary that explored the question What is the Future of Healthcare? from four connected perspectives—Inclusive, Global, Individual, Digital. Barbara Lopez Kunz, Global Chief Executive, DIA “We’re here this week because we imagine a world where powerful health interventions and tools are rapidly discovered,…
Italy Medac Pharma Italy’s Giovanni Sala describes the Italian affiliate’s unique portfolio of haematology, onco-urology, and neurosurgery products, as well as generics, and outlines the challenges of the Italian market. … in Italy we have developed a dual strategy: on one side in-licence local generic products; while on the other…
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.…
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