Tagged with AI

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…

Taiwan As a part of the World Health Organisation’s (WHO) COVID-19 Technology Access Pool (C-TAP), the Medicines Patent Pool has signed a worldwide license with Medigen Vaccine Biologics (MVC) for its COVID-19 vaccine, representing a debut on two fronts. Not only is this the first time a COVID-19 vaccine developed by…

UAE With cutting-edge hospital infrastructure being put in place, government authorities rolling out evermore supportive regulatory upgrades, big pharma championing ‘clinical trial diversity’ with greater non-Caucasian representation in trial cohorts, and a high regional prevalence of genetic diseases, it seems that the stage is set for the UAE to assume a…

Global Mohamed Meshref M.D, PhD is a Professor of Oncology at Cairo University and Regional Medical Director at Boehringer Ingelheim for India, Middle East, Turkey & Africa (IMETA). Here, Prof. Meshref discusses the importance of an ‘early medical affairs mindset’ within the pharma industry whereby medical affairs personnel engage much earlier…

Hong Kong Generative Artificial Intelligence (AI) has grabbed a lot of media attention in recent months following the launch of chatbot ChatGPT, but the pharmaceutical industry has long been trying – and struggling – to better integrate AI into the long and failure-fraught drug discovery process. While AI-enabled drug discovery may not…

China At a time when the country’s economy has fallen into a slump with the currency sinking to its lowest level in 16 years, Chinese giant Fosun Pharma continues to agressively advance its activities in everything from pharmaceuticals to medical devices and diagnosis to healthcare services. Through its multiple subsidiaries, as…

UAE Rodrigo Rodriguez, as area head for UMEA at Takeda, leads a vast and varied region that includes Ukraine, the Middle East and Africa and is characterised by what he calls “geographical and economic volatility,” with an extreme example being the conflict in Ukraine. He discusses the challenges presented by the…

Global Eli Lilly recently revealed more than promising clinical trial results for its Alzheimer’s candidate, donanemab, showing that the drug slows Alzheimer’s by as much as 60 percent in mild cases. While safety concerns about the drug remain, Lilly is hoping for an FDA approval by the end of the year.…

Global Following the appointment of new boards at the US innovative pharma industry body PhRMA, and its European counterpart EFPIA, it is global group the IFPMA’s turn to reveal a new CEO leadership team, with appointees from Pfizer, Roche and Daiichi Sankyo.   As the industry’s biggest global trade group that…

Spain Spanish mid-cap Esteve is selling a 26 percent stake in the company to German private investment firm Lubea, a move it says will supply the necessary funds to further pursue its redefined company strategy while stepping up growth and allowing for additional international expansion. Expansion: Products and Geographies Esteve, a…