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…

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…

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 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…

Ukraine Russia’s invasion of Ukraine has been roundly condemned by the pharmaceutical industry and almost all Big Pharmas have pledged humanitarian support to Ukraine. However, not all companies have followed the lead of businesses in other industries in severing ties with Russia, citing the importance of continuing to supply essential medicines…

Global When British executive Paul Hudson joined French pharma Sanofi back in 2019, he was quick to launch a “play to win” strategy, shedding underperforming areas and doubling down on its stronger assets.   While the COVID-19 pandemic – and Sanofi’s failure to bring a vaccine to market thus far, despite…

China The latest news from Chinese healthcare and pharma including Western pharmacos’ moves to license therapies from Chinese partners to sell globally, the seismic impact of new COVID lockdown restrictions in major Chinese cities, and the Chinese firms at risk of being delisted in the US if they do not hand…

Global In June 2021, as part of a broader restructuring, Merck (MSD globally) spun off its women’s health, legacy products, and biosimilars businesses. The new company formed, Organon, is positioning itself as “the only player of its size (USD 6.3 billion in revenues for 2021, 9,000 employees) focused on women’s health…

India Writing in the March 2022 edition of DIA’s Global Forum magazine, Ananya Chakraborty from the Vydehi Institute of Medical Sciences & Research Centre outlines the key factors behind India’s successful COVID-19 vaccination program.   January 16, 2022, was a proud day for India. The country achieved the milestone of completing…