Tagged with M

Switzerland Incyte’s Jonathan Dickinson discusses the company’s mission to address unmet medical needs in oncology and autoimmune diseases while expanding its footprint across Europe. He highlights the strategic role of Incyte’s internal research, clinical trials, and recent product launches, along with their ambitions to double European revenues in the coming years.…

Global The Top 10 medical device manufacturers for 2024 ranked by sales value for the past year. As compiled by Medical Product Outsourcing, Medtronic sits at the top of this year’s list with a full USD 32.36 billion in sales, driven primarily by organic rather than acquisition-based growth. J&J Medtech is…

Mexico The lowest spender on healthcare as a percentage of GDP in mainland Latin America. A complex and fragmented reimbursement system. Clinical trial approval delays stretching across eight months. One could be forgiven for thinking that attempting to bring innovative medicines to Mexico is a thankless task. Yet, as several country…

LatAm An overview of some of the biggest news from Latin American pharma, including Onconic Therapeutics’ licensing deal with Laboratorios Sanfer for 19 LatAm countries; Lupin’s orphan drug partnership with Argentina’s Celnova Pharma; Grifols’ distribution deal with Gema Biotech; the downturn in Uruguay’s medicinal canibis industry, and Novartis’ increased clinical trial…

France At the 13th annual meeting of French life sciences think tank, G5 Santé – which represents the leaders of eight major French health and life sciences companies, including bioMérieux, Sanofi, Ipsen, and Pierre Fabre – arguments were made for increasing efficiency in a healthcare system that is “on its last…

Switzerland Dr René Buholzer, CEO of Interpharma, covers Switzerland’s healthcare advancements, regulatory progress, and the challenges in drug access and digitalization over the past three years. Emphasising collaboration and innovation, Interpharma’s ‘Pharma Strategy 2030’ aims to solidify Switzerland’s leadership in R&D and healthcare sustainability.   Our vision is not just about…

Switzerland The Federal Office of Public Health (FOPH) is the body responsible for safeguarding public health in Switzerland, developing national health policies, and overseeing the Swiss healthcare system. In an exclusive conversation, FOPH Director Anne Lévy discusses the key challenges facing the Swiss healthcare system today and highlights potential solutions as…

Switzerland Thomas Wirth shares insights into Biomed’s strategic focus on the Swiss pharmaceutical market, offering comprehensive services from regulatory support to market access for RX and OTC products. He discusses Biomed’s commitment to long-term partnerships, technological advancements, and driving operational efficiency to stay competitive.   At Biomed, we prioritize delivering value…

Pharma Legal Handbook 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The National Agency for Regulation, Control, and Sanitary Surveillance (ARCSA), a decentralized Health Ministry (HM) agency, is responsible for applying and enforcing the regulatory framework regarding human medicines, biologicals, and medical devices.  …

Pharma Legal Handbook As a general introduction, clinical trials are regulated in Ecuador via the Ministerial Agreement (MA) 0075-2017 and reform 0006-2020, which relates to regulations for approving, developing, monitoring, and controlling clinical trials. This regulation was enacted on June 30th, 2017. Other rules and regulations make MA 0075-2017 enforceable. The Constitution of…

Legal Handbook 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? The authorization process for marketing new drugs, biologics, medical devices, OTC, and other medicinal products is through a marketing authorization as detailed in question 3 of Chapter 1.  …

Pharma Legal Handbook 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? The General Health Law (HL) and its regulations govern traditional, complementary, and alternative medicines. These medicines are known as natural, whose active ingredients are formed by any part of natural medicinal resources or combinations thereof,…