Tagged with GEN

Africa Medicines for Africa’s Lenias Hwenda argues that the success of the much-talked-about African Medicines Agency hinges on a critical mass of African national regulators achieving WHO Level 3 maturity status. While acknowledging the importance of international actors in making this happen, Hwenda argues that – if the African Medicines Agency…

Saudi Arabia Newly-appointed SPIMACO CEO Jérôme Cabannes outlines the ongoing transformation and growth of SPIMACO, focusing on leveraging existing assets while expanding through partnerships, new technologies, and market diversification. He highlights the company’s shift towards more complex products, such as biosimilars, and how its international acquisitions align with Saudi Arabia’s Vision 2030…

Saudi Arabia SPIMACO is well-known within the Middle East and North Africa, but less so internationally. Chairman Ahmed Aljedai explains how the company is changing that by actively expanding its international presence, including via acquisitions in Europe. He also traces SPIMACO’s journey towards becoming a full-spectrum pharma company covering the entire value…

China Reporting from Chinese language media outlet Yaozh, based on recently issued annual financial reporting, shows the leading R&D spenders among the (predominantly mainland Chinese) biotech companies listed on the Hong Kong Stock Exchange (HKEX). Local heavyweight Beigene invested almost three times as much on R&D last year as its nearest…

Global ISPOR—The Professional Society for Health Economics and Outcomes Research (HEOR), and PharmaBoardroom’s content partner, continues to monitor healthcare trends and conduct horizon scanning around the world. The “ISPOR 2024-2025 Top 10 HEOR Trends” marks the fifth publication of the Society’s biennial report, which is based on input from its members…

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…