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Portugal Part of PharmaBoardroom’s new country-focused series on market access and health technology assessment (HTA), this piece gives the lowdown on post-market approval processes and regulations in Portugal. Buy The Pharma Legal Handbook: Market Access & HTA – Portugal here for £359.   What are the pricing principles and processes in your…

Africa Speaking exclusively to PharmaBoardroom, Medicines for Africa’s Lenias Hwenda gives a comprehensive overview of the African Medicines Agency, why such a regulatory body was needed, how it differs from the European Medicines Agency, and its progress thus far. Hwenda also examines how the AMA stands to impact Africa’s clinical trial…

France The latest news from French pharma, including fears of medicine shortages and suspension of online sales of paracetamol, CARMAT’s artificial heart product entering a study in France, Sanofi’s expanded deal with Innate Pharma and new funding for cell and gene therapy biotech Cellectis.   France suspends internet sales of paracetamol …

Germany In response to a looming deficit of EUR 17 billion, Germany’s new Financial Stabilization of Statutory Health Insurance System Act (GKV-Finanzstabilisierungsgesetz, or GKV-FinStG) is aimed at containing costs in the country’s health insurance system by distributing the financial burden amongst all healthcare stakeholders, yet biopharma companies stand to be hit…

Egypt Egypt country managers tend not to stay in their roles for more than a few years, instead moving on to different pastures when new opportunities arise. However, those that do stay put – such as Roche’s Mohamed Swilam, now approaching his ninth year as general manager for Egypt – can…

USA David H. Crean, Managing Partner for Cardiff Advisory, discusses the economic impact of the signing and implementation of the Inflation Reduction Act (IRA) on the biopharmaceutical industry and innovation.   America’s biopharmaceutical research companies are researching and developing new medicines to meet unmet needs and continuing research and development even…

Global After gaining its first global approval in Indonesia, Takeda’s dengue fever vaccine, Qdenga, recently got a green light from the European Commission (EC) to market the vaccine in Europe, laying the foundation for further approvals in dengue-endemic regions like Latin America. We are one step closer to achieving our aspiration…

Americas Maria Gabriela Pittis, Head of SAM (South Cone, Andean Region, Mexico & Central America and Caribbean) at Takeda, outlines the company’s significant presence in the cluster, its double digit growth and plans to launch 14 new products there by 2025, most importantly its European Medicines Agency-approved dengue vaccine. She also…

Middle East & Africa General manager of MEA, Khaled Elrefae, explains how Ipsen has strengthened its footprint in the region over the past two years – starting in the UAE and expanding into Saudi Arabia – and in so doing turned MEA into one of its growth centres. As the company plans to increase…

Global Insights from US President Joe Biden’s chief medical adviser, Anthony Fauci, who served on the White House Coronavirus Task Force at the height of the pandemic, on the end of COVID-19, the danger of China’s recent surge in cases, preparedness for future pandemics, and the misinformation in the US that…

Global Over the past year, PharmaBoardroom has spoken to pharma executives the world over, collecting unique perspectives from all sides of the industry. Here are the ten most-read interviews of 2022 that range from conversations with one of Korea’s top CDMOs to the American generics association and the Italian regulatory agency,…

Europe Based on current discussions by the European Commission, launch conditionalities would not account for the distinct nature of small and mid-sized companies, OMPs and ATMPs. EUCOPE’s Alexander Natz breaks down this aspect of the revision of the general pharmaceutical legislation and why it would prove unsustainable for smaller companies and…