Korea Korean Pharma company, Hanmi has won orphan drug status this week from the US Food and Drug Administration (FDA) for HM43239, a drug for the treatment of acute myeloid leukaemia (AML).   The endorsement of FDA’s Orphan Drug Designation (ODD) — invented to smooth the development of therapies for life-threatening…

France As the UK prepares to leave the European Union in March 2019, stakeholders across the European life sciences industry are busy preparing for Brexit’s potential impact on their operations. In France, the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) – the country’s drug regulator –…

Cyprus With a population of just 1.2 million and a proportionately small pharmaceutical market by EU standards, Cyprus is often overlooked as a healthcare and life sciences investment destination. However, with the island now on the road to economic recovery following the EUR ten billion IMF-ECB-EU troika bailout in 2013, an…

France Ipsen CEO David Meek provides a fascinating look into the French pharmaceutical ecosystem, Ipsen’s bold global expansion plans, its R&D transformation, and the exciting changes to come.   From our roots as a French company, we have blossomed into a growing international player within the areas of oncology, neuroscience and…

Mexico Cristobal Thompson is the Executive Director at AMIIF (Asociacion Mexicana de Industrias de Investigacion Farmaceutica). The AMIIF represents more than 60 global companies with the aim of contributing to improving health in Mexico through innovative medicine. Here he discusses the new Alma-Ata Declaration that focuses on primary care and work at…

Algeria A sudden imposition of import restrictions on pharmaceuticals in 2017 has pushed several multinational companies to establish local production facilities in Algeria. However, the localization process can be fraught both for companies that establish direct manufacturing footprints via joint ventures and those that employ the services of local contract manufacturers.…

Canada Mark Ware, the Chief Medical Officer of Canopy Growth Corporation, has intensely investigated the effects of cannabinoids, making him perfectly placed to cover this new era of cannabis in healthcare.    I propose that the renaissance of cannabis under varying regulatory frameworks actually represents a paradigm shift in health care, and…

Regulation Chester “Chip” Davis, Jr, the President and CEO of the Association for Accessible Medicines (AAM) in the United States, discusses the contradictory nature of Trump’s efforts to lower drug prices.    The President has forcefully pledged to provide relief to these patients and their families, but his own trade policy threatens…

Innovation Patient groups oftentimes serve as the authority on a specific disease when it comes to advancing research.   “Without patient perspective, there is no good medical product development,” Rachel Sherman, the FDA’s principal deputy commissioner proclaimed during her keynote at last week’s NORD’s Rare Disease & Orphan Products Breakthrough Summit.…

Mexico David Peña Castillo is the President and founder of The Mexican Federation of Rare Diseases (FEMEXER). Here he discusses what makes a patients association. When we find a way to communicate the complexities of rare diseases simply, we can avoid isolating anyone and the potential to uncover important information is…

Biotech Pfizer has teamed up with Bain Capital to launch Cerevel Therapeutics, a biopharmaceutical company based in Boston that will focus on developing treatments for a number of central nervous system (CNS) disorders. It has almost been a year since Pfizer announced that they were to cease R&D in new neuroscience…

Japan Pharma Giant Johnson & Johnson (J&J) are set to swallow Ci:z, the Japanese skincare and cosmetics firm.    In a move to really establish themselves within the Asian skin care market, J&J will shell out 230 billion Japanese yen ($2.05 billion) in cash to take over the share of Ci:z…