Tagged with EU

Europe The European Federation of Pharmaceutical Industries and Associations (EFPIA) has elected a new president and vice presidents who have set out a key priority for their term: a series of amendments to the proposed European Commission (EC) pharmaceutical legislation reform, which the organisation has warned will further accelerate the loss…

Takeda Japanese-headquartered Takeda has been undergoing a transformation in recent years, becoming the global leader in rare diseases with the acquisition of Shire in 2018 and divesting ‘non-core’ assets in OTC and consumer goods. Here, four country and regional managers that PharmaBoardroom has spoken to in the past 12 months discuss…

Belgium Thanks to its world-renowned networks of medical and academic institutions, the long-standing presence of Big Pharma, and a favourable regulatory environment, Belgium has a well-established tradition of excellence in clinical trials. Pharma industry leaders and Belgian government officials weigh in on the factors threatening the country’s position as a clinical…

Belgium Nipro’s Serge Kemps explains how the COVID-19 pandemic and its after-effects led the Japanese-headquartered medtech firm to diversify its offering beyond its traditional area of focus, renal care, and establish a footprint in interventional cardiology. Kemps also outlines some of the challenges of moving towards a truly value-based healthcare system…

Europe Ahead of the much-discussed implementation of an EU-wide legislative framework on joint clinical assessments in 2025, Merck’s Nikola Vesic outlines the scope and aims of the reform and highlights some of the challenges in bridging the gap between theoretical vision and practical implementation.*     In 2022, the European Union…

Europe Writing in the June 2023 edition of DIA’s Global Forum magazine, Angelika Joos of MSD and Susanne Ausborn Roche consider some of the key takeaways from a workshop on regulatory reliance at DIA Europe 2023 which brought together international representatives from both industry and regulatory bodies.   Reliance* is considered the…

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,…

Belgium Gedeon Richter Benelux’s Isabelle de Walsche gives an update on the affiliate’s progress towards becoming a reference player in women’s health, looks back on some of her achievements over 11 years in position, and highlights some of the key issues on her agenda as pharma.be’s SME subgroup chair.   The…

India Top stories from Indian pharma including Sanofi India’s plans to demerge its healthcare businesses; Junshi Biosciences and Dr. Reddy’s anti-PD-1 monoclonal antibody partnership; Venus Remedies’ new oncology approvals; CORONA and Ferring’s maternal health agreement and Ipca Laboratories and Sun Pharma’s quality issues.   Zydus Lifesciences reports smallest profit in 14…

Europe As part of the EU’s Pharmaceutical Strategy for Europe, the European Commission has come out with a set of proposals to revise EU pharmaceutical legislation. The reforms, which aim to make medicines more available and accessible across Europe by reducing regulatory exclusivity, speeding up review processes and reinforcing supply chains…

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.  …

Belgium Despite the thriving life sciences ecosystem that has made Belgium one of the top European destinations for clinical trials, the country continues to grapple with considerable access challenges and remains behind many of its European counterparts. In a recent roadmap, the minister of health set out to improve the country’s…