Tagged with Medicines

China A selection of the latest stories from Chinese pharma, including Novartis’ bet that the country will become its second biggest market by 2024 through the introduction of 50 new drugs, a new report by McKinsey that evaluates China’s impact on the global biopharma industry, AstraZeneca’s respiratory plans, and Gilead’s USD…

Africa David Mukanga of the Bill and Melinda Gates Foundation gives an overview of the latest developments on the long road towards the creation of an African Medicines Agency and the push to establish vaccine manufacturing facilities on the continent.   Since the minimum number of 15 ratifications by African Union…

Europe The new president of Medicines for Europe, Elisabeth Stampa, outlines one of the priorities of her mandate: working to adjust the EU pharma policy framework to improve access for patients across Europe.    Regulatory flexibilities implemented during COVID-19 showed that the EU system can require one of highest safety, quality…

North America In April, the Canadian Ministry of Health announced the government would not be proceeding with certain proposed amendments to the Patented Medicines Regulations which govern the Patented Medicine Prices Review Board (PMPRB)—amendments related to new excessive price factors. The decision, well-received by Innovative Medicines Canada, came after these controversial economic…

Spain Weeks after a mosquito forced the recall of 765,000 doses of Moderna’s vaccine manufactured in Spain, the country’s top medicines regulator called for new inspection procedures, praised the loyalty of the Spanish pharma industry and asked if the industry is going “too lean?” Speaking at a conference in Madrid on…

Australia Writing in April edition of DIA’s Global Forum magazine, the University of New South Wales’s Richard Day looks at Australia’s National Medicines Policy (NMP) and how it is being reshaped by community and stakeholder feedback.   Australia’s National Medicines Policy (NMP), gazetted in 2000, is being revised and the draft policy was…

Global Shawview Consulting’s Brendan Shaw examines the WHO’s recently released updated Essential Medicines List. Shaw highlights some of the key trends and new inclusions in the List, why pricing and transparency are hotter topics than ever, and how pharma can incorporate this important document and its implications into their strategies for…

Denmark Established in 2017, the Danish Medicines Council is the health technology assessment (HTA)-like body in Denmark which assesses the value for patients and costs to society of new medicines. The Medicines Council then makes recommendations to the Danish Medicines Agency (the country’s regulator) and Amgros (the national public procurement body).…

Denmark Jørgen Schøler Kristensen explains the role of the Danish Medicines Council, providing guidance about new medicines for use in the Danish hospital sector. Kristensen also tackles the thorny issues of price considerations, assessing the long-term efficacy of innovative new therapies, and working collaboratively with private industry.   There is a…

Global Over the past 12 months, PharmaBoardroom has spoken to the heads of several key regulatory bodies across the world. While the approval processes for COVID-19 vaccines have evidently been top of their priority lists, other key topics discussed included the potential of data and AI to change the drug approval…

Denmark In a wide-ranging interview, incoming director general of the Danish Medicines Agency Lars Bo Nielsen discusses the challenges that personalised medicine presents to regulators, building a stronger international presence for the Agency, and better leveraging the country’s world-class data infrastructure while respecting the EU’s data protection regulation.   Within Europe,…

Global Following the recent news of Remegen’s massive USD 515 million IPO in November 2020, we bring you profiles of the seven biggest biotech companies to IPO in 2020. Notably, six of the seven companies are from China, pointing to the massive growth of the Chinese biotech market.   Remegen RemeGen,…