Africa Medicines for Africa’s Lenias Hwenda reflects on Moderna’s recent decision not to go ahead with plans for a vaccine manufacturing facility in Kenya, and why local production remains crucial to building Africa’s healthcare autonomy. In a turn of events that is both disappointing yet somehow not surprising, Moderna recently…
ASEAN A roundup of some of the most important recent pharma news from the dynamic ASEAN region, including a big new investment from Novartis in its antibody plant in Singapore, the establishment of ‘pharmaceutical ecozones’ to streamline the drug application process in the Philippines; Vietnam’s journey to attaining WHO Level Four…
Pharma Legal Handbook 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, non-prescription medications, and other medicinal products? Please refer to Chapter 1, Question 3. 2. What is the authorization process for the marketing of generic versions of these products? Please refer to Chapter 1, Question…
Portugal From software development to sales and consultancy, Alexandre Leiria today heads up the Life Sciences, Healthcare, and Manufacturing arm of digital-focused consultancy Capgemini in Portugal. He discusses Capgemini’s role in advancing digital transformation in the Portuguese healthcare sector. Despite progress, challenges remain, such as the need for further investments and…
India The IDMA’s Daara Patel outlines the association’s role in representing the diverse voices of the Indian pharmaceutical sector, advocating for manufacturers of all sizes. He explores the challenges and initiatives around aligning with global standards, addressing issues like regulatory complexities and the shift towards biologics. Patel also uncovers the Indian…
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)…
Global Smart manufacturing has become a key component of today’s industrial evolution and unlocked unprecedented efficiencies and quality enhancements. Smart Manufacturing expert Eric Whitley outlines the specific benefits of smart manufacturing for the pharmaceutical industry, illustrating these benefits with industry case studies. Smart manufacturing has entered the world of modern…
Hong Kong With the global market for cell and gene therapy (CGT) products set to skyrocket in the coming years, Hong Kong is looking to get in on the action with the opening of a new Advanced Therapy Products (ATP) Good Manufacturing Practice (GMP) Centre earlier this month. Leveraging the city’s…
South Africa Roughly half of Africa’s 1.1 billion people lack regular access to even the most essential medicines and most of Sub-Saharan Africa depends on imports which make up as much as 70 to 90 percent of the medicines consumed there. As the COVID-19 pandemic further demonstrated this dependence and the vulnerability…
Greece DEMO, founded in 1965, is a mainstay of Greek pharma and one of its largest companies, accounting for 25 percent of the total investment across the entire Greek pharmaceutical sector. Throughout its long history DEMO has shifted its focus, moved towards exports and weathered Greece’s financial crisis. Today, the family-owned…
Africa Diabetes is a significant, and growing, problem in Africa, making access to insulin products a regional imperative. Some important progress is being made, including a new deal between US giant Eli Lilly and Egyptian group EVA Pharma. The agreement will allow Lilly products to be manufactured in, and for, the…
Greece The European Union’s decision to mitigate the effects of the COVID-19 pandemic by launching its Recovery and Resilience Facility (RRF) and moving away from its past austerity policies is particularly significant for Greece. Severely hit by the financial crisis a decade ago and thrown off its course to recovery by…
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