Tagged with EUROPE

France Lionel Collet, president of France’s Haute Autorité de Santé (HAS), explains the role of the independent public authority, which extends beyond health technology assessment (HTA) to clinical practice guidelines and certifying hospitals, and its unique position as a separate body outside of the Ministry of Health. He describes France’s early…

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…

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…

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…

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…

Spain Thanks to what AstraZeneca country president Rick Suarez called a “thriving life-science eco-system and highly-skilled talent pool,” along with Spain’s leading position in clinical trials, the British Big Pharma is intensifying its commitment to the country with a total investment of EUR 1.3 billion its new global R&D hub in…

Europe PharmaBoardroom caught up with Niklas Hedberg at DIA Europe 2024 in Brussels to gauge what more needs to be done ahead of the implementation of European HTA regulation in January 2025. Hedberg, who spoke at a host of panels across the event, also gave his take on the EU Pharma…

Europe PharmaBoardroom was delighted to attend DIA Europe 2024 in Brussels earlier this month, bringing together a veritable who’s-who of the European and global regulatory community. The politicians, regulators, payers, patient advocates, industry representatives, and service providers in attendance were treated to a three-day buffet of engaging panels and townhalls with…