Tagged with P

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…

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…

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…

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…

Italy Ipsen’s Stephane Brocker discusses a transformational period for the iconic French mid-cap in recent years, how this has played out in Italy, and emergent trends – such as hybrid digital/in-person physician interactions – that have emerged from the COVID-19 pandemic period. Brocker also touches on Italy’s relevance to the global…

Spain Kern Pharma’s chairman and Grupo Indukern CEO, Raúl Díaz-Varela, explains the new strategic direction of the Spanish generics player, how their partnership with Celltrion to commercialise biosimilars has evolved, and analyses the main developments shaping the country’s generics industry, including regulatory changes and pricing policies. In addition, he comments on…