Tagged with GEN

USA Francesco Lanucara of PharmaLex, writing in the November 2023 edition of the DIA’s Global Forum magazine takes a look at how new guidance from the US FDA aims to tackle the myriad challenges of cell and gene therapy manufacturing comparability and complexity.   Development of cell and gene therapy (CGT)…

Europe Pfizer’s David Isom and Monica Mihedji, writing in the November 2023 edition of the DIA’s Global Forum magazine, examine how the European Medicines Agency is attempting to integrate the use of artificial intelligence in its regulatory work.   Regulators are advancing information technology and data modernization initiatives to drive more…

Global Dr Vivienne Marshall, senior director of the Center for Advanced Therapies at the South Texas Blood & Tissue Center, part of BioBridge Global, outlines some of the major barriers to wider adoption of cell and gene therapies: complexity, variability, and the lack of robust standards. Dr Marshall also highlights the…

UAE Drawing on a quarter of a century of pharmaceutical industry experience, over 20 years of which has been spent in the UAE, Ayman Mokhtar today heads up Middle East, North Africa and Eurasia operations for Viatris. A global healthcare company with a broad range of products, Viatris is continually working…

Morocco Cooper Pharma is one of Morocco’s leading domestic pharmaceutical manufacturers and has expanded its presence across Europe, the Middle East, and Africa in recent years. CEO Ayman Cheikh Lahlou emphasizes the importance of healthcare investment for a developing nation, highlighting Morocco’s commitment to self-sufficiency in pharmaceuticals, the potential for Morocco…

Morocco Zenith Pharma’s Mohamed El Bouhmadi discusses the company’s approach to product development and the potential for Morocco to become an African pharmaceutical export platform. As Morocco transitions to universal healthcare coverage, he highlights the need for balanced medication pricing. With a robust growth trajectory and a focus on high-value products,…

Morocco The general director of the National Health Insurance Agency (ANAM) Dr Khalid LAHLOU outlines the role of the agency as the sole regulatory authority for Morocco’s compulsory health insurance (CHI) within the current context of healthcare reform. He discusses the future challenges facing both new and existing coverage schemes, the…

Spain A roundup of the latest news from Spanish pharma, including Almirall’s licensing deal with EpimAb Biotherapeutics; the opening of Insud Pharma’s oligonucleotides centre in India, and Esteve Química’s new FDA-cleared manufacturing site.   Almirall licenses bispecific platform in $210m EpimAb deal (BioProcess International) EpimAb Biotherapeutics has out-licensed the rights for…

Switzerland As former parent company Novartis centres its efforts on its “pure-play” innovative medicines business, Sandoz is increasingly betting on biosimilars. Having already launched a version of AbbVie’s blockbuster arthritis treatment Humira, the newly spun-off company has been gearing up for its independence by preparing additional biosimilar launches, signing big partnership…

Morocco Salim El Guermaï of leading Moroccan generics manufacturer Galenica outlines how, in the past three years, the firm played a key role in Morocco’s COVID-19 pandemic response, continued to serve Moroccan patients with essential medicines, and bolstered the country’s standing as a pharmaceutical hub for the African continent.    Our…

Morocco Three years on from his last PharmaBoardroom interview, Karim Lahlou highlights the evolution of Moroccan pharma manufacturer Iberma as it expands its activities from solely in-licensing to developing and selling its own products, growing its global partnership base, and looking to penetrate international markets while leveraging the growing reputation of…

Morocco Recently rebranded from its former name, AMIP, the Moroccan Federation of Pharmaceutical Industry and Innovation (FMIIP) represents the local manufacturers operating in Morocco, which hold a domestic market share of 75 percent. Executive Director Layla Laassel Sentissi highlights some of the key trends in the Moroccan pharma market today, how…