Tagged with B

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…

Morocco Last year, the USA surpassed France as Morocco’s largest source of foreign direct investment, and Morocco is the only country in Africa to boast a free trade agreement with the US. AmCham Morocco’s Rabia El Alama outlines some of the major trends underpinning the US-Morocco trading relationship, the weighting of…

LatAm A roundup of some of the latest news from Latin American pharma, including Acino’s acquisition of M8 Pharmaceuticals; AstraZeneca’s growth in Mexico; Neuraxpharm’s expansion into Brazil and Mexico, and Columbia’s decision to issue a compulsory license for GSK/ViiV’s HIV treatment.   Colombia set to issue a compulsory license for an…

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…

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…

UAE Drawing on two decades of experience within Bayer Consumer Health Middle East, and now as VP and head of the firm’s Middle East/Pakistan Cluster, Mohamed Galal discusses the transformative impact of the COVID-19 pandemic on the pharmaceutical landscape, Bayer Consumer Health’s strategic outlook in a region where healthcare awareness is…

UAE As the UAE’s only gastrointestinal oncologist, Professor Humaid Al-Shamsi is well-placed to comment on the evolution of cancer care in the country, noting massive leaps forward in terms of technology, patient experience, and regulatory timelines. Looking forward, Professor Al-Shamsi calls for even greater investment into oncology R&D programs as the…

Global Claudia Martínez, generic & biosimilar medicines programme manager at the Access to Medicine Foundation, draws from a recent AMF report to outline what more generics companies can be doing to ensure greater access to their essential products. Martinez argues that for people living in low-and middle-income countries (LMICs), generic and…

Global After a 12-year stint at Sanofi, Bill Sibold is leaving Big Pharma to join the Pennsylvania-based biotech Madrigal Pharmaceuticals as CEO. Sibold, no stranger to ground-breaking launches, having brought the blockbuster Dupixent to market, will be coming onboard just ahead of what looks to be a pivotal moment for Madrigal.…

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…