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Global 2023 was a breakthrough year for cell and gene therapies. The field saw a record number of FDA approvals, as other promising therapies in a broad range of therapeutic areas progressed through the pipeline. 2024 looks to be another important year with up to 17 new therapies poised for regulatory…

Africa Nigeria has become the first country to roll out a new meningitis vaccine. The product, a shot able to protect against the five causes of meningococcal meningitis, was developed by the Serum Institute of India (SIIPL) and health equity non-profit PATH. With more meningitis vaccine-based projects in the pipeline, stakeholders…

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 Baxter Saudia Arabia GM Faisal BinDail shares some insights into the renal care specialist’s local manufacturing hub, the sole manufacturing site for peritoneal dialysis products in the Middle East, and the company’s plans to expand its reach in Saudi Arabia and the broader region.   We aim to provide our…

Saudi Arabia Basel Al-Qahtani, General Manager of Boston Scientific Saudi Arabia, discusses how Boston Scientific has expanded its operations to establish a fully fledged regional headquarters in the kingdom. He outlines the company’s commitment to Saudi Arabia’s Vision 2030 agenda through public-private partnerships and potentially through accountable care organizations, and underlines the…

Saudi Arabia Since joining Moderna as its first ex-US commercial employee in Spring 2020, Dan Staner has played a leading role in developing what is now one of the world’s top 20 biggest pharma companies. Speaking exclusively to PharmaBoardroom, Staner describes how Moderna has been able to fashion a new, optimised company…

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…

Global After seven years at the helm of the pharma industry’s biggest global trade group, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Thomas Cueni is retiring. Having played a key role in coordinating innovative pharma’s successful response to the COVID-19 pandemic among other achievements, Cueni is passing the reins…

India Sanjay Bhutani of Bausch & Lomb outlines why the medical devices sector in India is poised for substantial growth, bolstered by increased government support and a higher healthcare budget. He also explains how the 2023 National Medical Device Policy marks a significant shift towards recognizing the distinct needs of the…

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…

Germany The biggest pharma industry and healthcare stories from Germany, including the country’s legalisation of cannabis; the MASH potential of Boehringer Ingelheim’s obesity candidate; Bayer’s further share price drop and expansion into the US; the antibody-drug conjugate (ADC) specialist Tubulis’ series B2 financing, and Novartis’ deal with biotech MorphoSys.   Germany’s…