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Europe In an extensive recent PharmaBoardroom conversation, EMA Head of Advanced Therapies Ana-Hidalgo-Simon highlighted some of the most important trends around advanced therapy regulation in Europe. Hidalgo-Simon touched on why moderate growth in regulatory applications is a positive development for the EMA, how patient insights are being better incorporated into the…

UAE Fokion Sinis, Sanofi Vaccines’ General Manager for the Greater Gulf Multi Country Organisation, outlines some of the key impacts that the COVID-19 pandemic has had on the vaccine industry, the five ‘A’s of successful vaccination campaigns, and his ambitions for the future at a moment of great transformation for both…

Germany The latest from German pharma, including Bayer’s 2021 financial results, the country’s plan to spend $3.14 billion on vaccine capacity to cover Covid-19 outbreaks until 2029, and Boehringer Ingleheim’s case for broader use of its diabetes drug.   Bayer’s 2021 annual report: €44.1 billion revenue, Crop Science grows double digits,…

China Despite rapidly developing and rolling out two vaccines against COVID-19 – from domestic firms Sinopharm and Sinovac – China is yet to approve a vaccine that uses mRNA technology, either from a domestic firm or one of the two international products (Pfizer/BioNTech and Moderna) currently approved elsewhere.   As the…

Europe Speaking exclusively to PharmaBoardroom, the EMA’s Head of Advanced Therapies Ana Hidalgo-Simon discusses steadily growing numbers of regulatory applications in the advanced therapy field, the vital importance of patient group insights, RWE collection and curation, hospital exemptions, manufacturing challenges, and more.   [Advanced] therapies are complex, difficult, and have a…

USA Ramona Sequeira, recently appointed chair of the PhRMA board of directors and president of Takeda’s US Business Unit and Global Portfolio Commercialization, gives her take on how the biopharma industry can do more to address the systemic inequities in US healthcare, including community-focused grant programs, clinical trial diversity initiatives, and…

Korea KHIDI’s Soonman KWON outlines the public health R&D funding landscape in Korea, plans to increase Korea’s capacity to develop and produce its own vaccines in the wake of the COVID-19 pandemic, and how Korean infrastructure and expertise is helping train up scientists from low- and middle-income countries.   My hope…

Spain Margarita Alfonsel, general secretary of Fenin, the Spanish Federation of Healthcare Technology Companies, reflects on the COVID-19 pandemic, the changing dynamics of the medical technology industry in Spain, and comments on key policy changes that Fenin’s members are advocating for.   The pandemic has put [the medtech] sector in the…

Spain AseBio is the association promoting the development of the Spanish biotechnology industry. Its general manager, Ion Arocena, lays out the main priorities for the country’s sector, including the need to reevaluate public funding mechanisms at a national and European level, and provides an explanation for Spain’s leadership in clinical trials…

Korea Two decades ago, South Korean company Celltrion embarked on a quest to find the necessary resources to produce biopharmaceuticals. It took five years for their manufacturing plant to receive GMP certification from the US FDA in 2007 and another one to launch an initial public offering; an ascent that, while…

Europe A roundup of the latest news from European biotech, including BioNTech and CureVac’s German vaccine manufacturing deal; the revival of Valneva’s plans to manufacture its vaccine in Scotland; and Morphosys’ shuttering of its US R&D footprint.   BioNTech, CureVac part of $3.14B deal to bolster German vaccine capacity through 2029:…

LatAm Writing in the March edition of DIA’s Global Forum magazine, the University of Southern California’s Viktoria Magyar looks at how Latin American regulatory bodies adapted to the COVID-19 pandemic and what some of its longer-term impacts on regulatory activities in the region might be.   Driven by increasing workloads, limited…