Tagged with EMA

Saudi Arabia Osama Braiwish leverages over 26 years of industry experience across the Gulf region and Saudi Arabia. He joined Bristol Myers Squibb (BMS) in 2024, drawn to the company’s commitment to addressing significant unmet medical needs in oncology, hematology, immunology, cardiovascular and neuroscience. In his first few months at BMS, Braiwish…

Europe While Europe has lost some of its global share of clinical trials to China and the US, it remains a clinical research stronghold. Three years into the Accelerating Clinical Trials in the European Union (ACT EU) initiative which aims to transform how trials are initiated, designed, and run across the…

Europe The EMA’s Pre-Accession Assistance Program (IPA) helps EU candidate and potential candidate countries align their medicines regulations with EU standards through training, capacity-building, and policy support. As a new op-ed in the February 2025 edition of DIA’s Global Forum magazine outlines, an impact assessment of IPA II (2020-2023) showed significant…

Global In an era of rapid scientific breakthroughs, global regulators are navigating new challenges—accelerating approvals, harmonising standards, and integrating digital tools—while balancing safety, efficacy, and access. Throughout 2024, PharmaBoardroom spoke with regulators worldwide to uncover the key regulatory trends shaping the future of healthcare in 2025 and beyond.   The Road…

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…