Tagged with GEN

Europe The EMA’s Peter Arlett looks back on two years of the Accelerating Clinical Trials in the European Union (ACT EU) initiative which aims to improve the environment for clinical trials in the EU by transforming how trials are initiated, designed, and run. In conversation following DIA Europe 2024 in Brussels,…

LatAm A roundup of some of the latest stories coming out of Latin American pharma and healthcare, including Merck’s new distribution centre in Brazil; the region’s record dengue surge; Roemmers Laboratory’s acquisition of 30% of Argentina’s Tuteur, and Urufarma’s new manufacturing facility in Uruguay.   Merck to open new distribution centre…

Saudi Arabia Ismail Shehada explains his decision to join leading Saudi firm Tabuk Pharmaceuticals, influenced by its potential for growth and strategic transformation in alignment with Saudi Vision 2030. He outlines the need to transition from consultancy-driven strategies to business implementation, aligning with the national agenda and achieving market leadership.   As…

Europe PharmaBoardroom was delighted to attend DIA Europe 2024 in Brussels earlier this month, bringing together a veritable who’s-who of the European and global regulatory community. The politicians, regulators, payers, patient advocates, industry representatives, and service providers in attendance were treated to a three-day buffet of engaging panels and townhalls with…

Denmark In conversation at DIA Europe 2024 in Brussels, Lars Bo Nielsen lays out the digital transformation that the Danish Medicines Agency has undergone over the past three years and how AI can best be integrated into the work of national regulatory bodies.   What does AI really mean? How can…

Opinion Writing in the March 2024 edition of the DIA Global Forum magazine, experts from Moderna, Cencora PharmaLex, CureVac, and BioNTech review the scientific potential and regulatory challenges, such as the lack of global harmonization, surrounding gene therapy-based medicinal products. Gene therapy medicinal products (GTMPs), which in the European Union (EU)…

Switzerland The biggest pharma news from Switzerland, including the industry’s cautious reaction to a new free trade deal with India; the drop in Roche’s share prices; Novartis’ acquisiton of MorphoSys, and the licence agreement between EraCal Therapeutics and Novo Nordisk.   Swiss industry welcomes agreement with India, pharma more cautious (Le…

Global Pharma is rushing to adopt AI-driven tools in the hope of revolutionizing everything from drug discovery to clinical trials, regulatory submissions, and marketing efforts. While AI is the technology du jour, Saskia Steinacker, senior VP, global head strategy and digital transformation at Bayer, argues that successful AI implementation within Pharma…

China No longer a fledgling biotech, oncology-focused BeiGene, originally created in China in 2010 with the idea of carrying out world-class research there, has since expanded its global reach and garnered approvals for its therapies Brukinsa and Tevimbra. The company is on a growth trajectory with product sales reaching USD 2.2…

LatAm An overview of some of the biggest stories from Latin American pharma and healthcare, including Brazil’s rollout of dengue vaccines following a sharp increase in cases; the Brazilian  regulatory agency ANVISA’s strategy to become a WHO-listed authority andAspid Pharma’s agreement with Institute for Research on Obesity of the Tecnológico de…

Portugal Luis Abrantes explains how Generis, as one of the leading companies by volume in both the retail and hospital segments of the Portuguese pharma market, serves a huge number of patients in the country. Starting out in 2003 as a family-owned firm, it was then bought out by private equity…

Portugal Azevedos Group’s João Sotana outlines the firm’s diverse strategic pillars, including manufacturing for Portugal and international markets; its focus on sustainability and innovation; and how it plans to stay ahead of the pack in the competitive generics market, including via expansion into the US market with a focus on freeze-dried injectables.…