Tagged with EU

Spain A roundup of the biggest stories emerging from Spain’s pharma industry: Grifols pushes to improve governance after accusations of overstated earnings; Rovi and Insud join forces to create Spain’s first semi-public pharmaceutical company; Almirall and Eloxx Pharmaceuticals sign a licensing agreement for a rare dermatological disease asset, and Esteve acquires…

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…

Saudi Arabia Diederik Kok, Head of GCC, discusses his experience piloting Biogen’s newly established direct presence in the region and reviews its varied neuroscience landscape and the importance of tailoring the organization’s approach. He also speaks about Biogen’s commitment to conducting clinical trials in the GCC, its recent risk-sharing agreement with the…

France FACOPHAR Santé is the French association for actors operating in the natural and herbal remedies field. In conversation with PharmaBoardroom, long-term president Jacques Vernin explains how the organisation promotes French excellence in botanicals and highlights two important new initiatives: an FDA GMP certification programme which has opened up fresh export…

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…