Tagged with EG

Spain Teva’s general manager for Spain and Portugal, Juan Carlos Conde Ibarra, dives into the recently announced strategy for the affiliate, including the move to a single brand in generics, and a bigger focus on specialty products, biologics and digitalization. In addition, he reflects on his 18 years with the company,…

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…

LatAm Writing in the March edition of DIA’s Global Forum magazine, the University of Southern California’s Viktoria Magyar looks at how Latin American regulatory bodies adapted to the COVID-19 pandemic and what some of its longer-term impacts on regulatory activities in the region might be.   Driven by increasing workloads, limited…

Global When British executive Paul Hudson joined French pharma Sanofi back in 2019, he was quick to launch a “play to win” strategy, shedding underperforming areas and doubling down on its stronger assets.   While the COVID-19 pandemic – and Sanofi’s failure to bring a vaccine to market thus far, despite…

Italy Ipsen’s Stephane Brocker discusses a transformational period for the iconic French mid-cap in recent years, how this has played out in Italy, and emergent trends – such as hybrid digital/in-person physician interactions – that have emerged from the COVID-19 pandemic period. Brocker also touches on Italy’s relevance to the global…

Spain Ferrer’s CEO, Mario Rovirosa, outlines how he and a new management team have been building the foundation of the Spanish mid-cap’s transformation to become a specialty pharma company, a 180-degree shift that entailed the divestment of its generics portfolio, new affiliates across the world, and a more focused product pipeline.…

Italy In a wide-ranging conversation, veteran general manager of Teva’s Italian Cluster Hubert Puech d’Alissac explores the reasons for the company’s growth in the region to become the generic market leader, post-COVID changes to the pharma industry, and the state of private-public relationships in Europe. Furthermore, d’Alissac touches on the responsibility…

Spain Biogen’s managing director for Spain, Sergio Teixeira, reflects on the company’s key role in transforming multiple sclerosis and spinal muscular atrophy as examples of the American biotech giant commitment to transforming neuroscience. The Portuguese executive also analyzes what he describes as a “positive” momentum for biosimilars in Spain amongst his…

Spain Bial’s general manager for Spain and global director of its epilepsy franchise, Ana Álvarez, highlights the importance of the country for the organization – representing 25 percent of overall sales –, explains how she is managing the lifecycle of Bial’s CNS and cardiovascular portfolio, the importance of sustainability, and  the…

Japan An overview of the new medicines approved by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) between April and November 2021. See the 2020 data here and the full PMDA approval archive here. Made with Visme Infographic Maker

USA A comprehensive list of the US FDA’s Center for Drug Evaluation & Research (CDER)’s new drug therapy approvals for 2021. CDER approved 50 new drugs in 2021, down from 53 in 2020, either as new molecular entities (NMEs) under New Drug Applications (NDAs), or as new therapeutic biologics under Biologics…