Tagged with tech

Pharma Legal Handbook 1. Please describe the main cost containment policies in place in your country and their fundamental principles: a. Pricing and impact of generic/biosimilar approval The entry of generics/biosimilars into the market affects the price of original drugs by three main mechanisms: (i) homogeneous groups (“HG”), (ii) reference groups (“RG”), (iii)…

Pharma Legal Handbook 1. Has an essential or priority drug list been published in your country? (If so provide the link) Yes. Three types of lists have been published by the AEMPS: “Essential medicinal products”: according to the WHO definition, these are the necessary medicinal products for a basic health system. “Critical medicinal…

Pharma Legal Handbook 1. What is the definition of an orphan drug in your country? In Spain there is no particularity in relation to the definition of “orphan drug” derived from the Regulation (EC) No 141/2000. Under Regulation (EC) No 141/2000 a medicinal product shall be designated as an orphan medicinal product if…

Pharma Legal Handbook 1. What is the definition of a vaccine in your country? The AEMPS defines a vaccine as an antigen-containing preparation capable of inducing specific and active immunity in humans against an infecting agent or the toxin or antigen elaborated by it. Immune responses include the induction of innate and adaptive…

China A decade on from its launch, the Guangdong-Hong Kong-Macao Greater Bay Area (GBA) initiative has made some significant wins but remains some way from fulfilling the vision of a fully integrated internationally competitive bay area to rival that of its US west coast namesake.   Staggering Fundamentals Home to 87…

Hong Kong 2018 marked a significant milestone in Hong Kong’s journey towards creating a vibrant biotech market for investors which allows Asian innovation to receive the funding it needs to progress. It was in that year that the Hong Kong Stock Exchange (HKEX) launched the bold and visionary move of allowing clinical-stage…

USA Having become one of the 20 youngest US billionaires as founder and CEO of disruptive biotech firm Roivant Sciences, Vivek Ramaswamy has now set his sights on becoming his country’s president. A long-term critic of how ESG criteria are used in corporate decision-making, Ramaswamy has since gone even further to…

USA Biotech and life sciences companies have a habit of clustering together, creating shared ecosystems to drive innovation. For going on 12 years Johnson & Johnson Innovation (JLABS), has been supporting this strength in numbers philosophy, finding, funding and incubating promising startups under a scheme of open innovation in its shared…

Belgium Encircled by heavyweight life sciences powerhouses of the likes of Germany, France and Switzerland, plucky Belgium nonetheless continues to astonish and project considerable influence when it comes to its abilities to develop, manufacture and sell medicines.   Despite representing only a mid-size marketplace from an in-country commercial perspective, the comparatively…

Middle East & Africa As profit margins in established markets decreased, “pharmerging markets” became the new El Dorado for pharma and medtech companies in the 2010s. Many put in big investments only to discover that the volatility of these geographies often meant that the expected returns did not materialise. However, especially post-COVID, emerging markets…

Hong Kong Since first allowing pre-revenue biotechs to list in 2018, the Hong Kong stock exchange has welcomed 59 such companies and is now a leading vehicle for allowing Chinese biopharma to access international capital. Christina Bao, HKEX’s co-head of sales and marketing, discusses listing momentum picking up again after a rocky…

Hong Kong Fresh from the news that one of its AI-designed and discovered drug candidates has entered Phase II human clinical trials – the first time that such a project has made it to that development stage – Insilico Medicine’s Alex Zhavoronkov sat down with PharmaBoardroom to discuss a range of topics.…