LatAm For the second consecutive year, DIA Europe hosted a Latin America Town Hall, a panel discussion to foster collaboration and share updates from regulatory activities in Latin America and Europe, and the intersections between them. MSD’s Leonardo Semprun, writing in the May 2024 edition of DIA’s Global Forum magazine, highlights…
Korea A roundup of some of the biggest stories from South Korean healthcare and pharma, including the government’s continuing standoff with doctors over medical reform plans; Merck’s plans for a new 300-million-euro plant; EuBiologics’s World Health Organization (WHO) prequalification for its cholera vaccine, and Samsung Biologics’ record Q1 earnings. South…
France The biggest stories from French healthcare and pharma, including AstraZeneca’s acquisition of Amolyt Pharma; protests over Sanofi layoffs; Pierre Fabre’s purchase of Kinnate Biopharma’s experimental pan-RAF inhibitor, and French biotech SeaBeLife’s EUR 1.5 million funding round. Withdrawal of a flu vaccine due to a price dispute between Sanofi and…
Pharma Legal Handbook 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The Ministry of Health and Care Services (Helse- og Omsorgsdepartementet, “HOD”) is the superior administrative authority in Norway, with jurisdiction over drugs, biologicals, and medical devices. The Norwegian Medical Products Agency (Direktoratet…
Spain Brazilian national Maria Fernanda Prado, who began her career in pharma more than 20 years ago, has been at Janssen/Johnson & Johnson for more than half of that time. She has taken on the leadership of a diverse set of geographies — from Turkey to Central Europe and Benelux —…
Global 2023 was a breakthrough year for cell and gene therapies. The field saw a record number of FDA approvals, as other promising therapies in a broad range of therapeutic areas progressed through the pipeline. 2024 looks to be another important year with up to 17 new therapies poised for regulatory…
Mexico The latest stories from Mexican pharma and healthcare, including Sanfer’s purchase of Colombia-based manufacturer Vitalis; Organon Mexico’s new business; the FDA’s warning to Glicerinas Industriales, and a look at the issues, including health, the new Mexican president will have to face. Mexico’s Health Ministry issues measles alert (Mexico News) Mexico’s…
Switzerland While the Swiss biotech sector is inevitably facing many of the same funding challenges as the global industry and is still struggling to make a meaningful comeback from its 2022 slump, the latest report from the Swiss Biotech Association and EY shows the sector’s resilience with the record revenues of…
Italy A roundup of some of the biggest stories from Italian pharma and healthcare, including Italfarmaco’s FDA approval for its DMD treatment; Alfasigma’s acquisition of Galapagos’s Jyseleca, the antibiotics deal between Venatorx Pharmaceuticals and Menarini, and the country’s drop in healthcare spending. Stevanato Group Announces Public Offering of Ordinary Shares…
UK A roundup of some of the biggest stories coming out of the UK pharma industry, including AstraZeneca’s bid for cancer specialist Fusion Pharmaceuticals; the shutdown of Sanofi’s R&D site in Cambridge; the GBP 17.9 million initiative to boster UK clinical trials, and Obsidian Therapeutics’ USD 160.5 million Series C funding raise.…
Europe The EMA’s Peter Arlett looks back on two years of the Accelerating Clinical Trials in the European Union (ACT EU) initiative which aims to improve the environment for clinical trials in the EU by transforming how trials are initiated, designed, and run. In conversation following DIA Europe 2024 in Brussels,…
Global Latin America will be the world’s fastest growing region for pharmaceuticals up to 2027, with a stunning expected compound annual growth rate of 22 percent, according to recent reporting from IQVIA. The Indian subcontinent can also expect sizeable growth over the next three years, although the US, Europe, and East…
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