Tagged with Europe,

Opinion Writing in the March 2024 edition of the DIA Global Forum magazine, experts from Moderna, Cencora PharmaLex, CureVac, and BioNTech review the scientific potential and regulatory challenges, such as the lack of global harmonization, surrounding gene therapy-based medicinal products. Gene therapy medicinal products (GTMPs), which in the European Union (EU)…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Switzerland.  1. Which are the health technology assessment (HTA) evaluation bodies and their responsibilities in your country? The National HTA program is overseen by the Health Technology Assessment Section (HTAS) of the HIBD (see above chapter…

France After offloading its consumer healthcare division in 2022 and in view of the gradual erosion of its top seller, Somatuline, Ipsen opted to aggressively seek external assets to enrich its pipeline. With an FDA green light for its 2017-acquired Onivyde and an expected approval for its Genfit-partnered therapy this year,…

France France is the third most significant clinical research destination in Europe, participating in 50 percent of the trials initiated across the continent. While favourable government policies and unique strengths such as the National Health Data System contribute to France’s competitiveness, obstacles to further growth remain. In conversation with PharmaBoardroom, Hubert…

Portugal After achieving the highest sales figures in the affiliate’s history in 2023, general manager of Teva Pharmaceuticals Portugal Marta Gonzalez Casal outlines the restructuring efforts that have taken place in Portugal to strengthen its commercial operations. She also reviews the company’s shift towards innovation and the challenges of Teva’s hospital…

France Hubert Mechin, president of AFCROs, the association that groups clinical research organisations in France, details the organisation’s efforts to help its members stay abreast of changes in the European regulatory environment and its creation of a clinical research code of conduct. He discusses France’s competitive edge in clinical trials based…

Portugal While not a major player in clinical trials at the European level, Portugal has untapped potential in this field, leveraging a first pioneering centre in Braga, the country’s strong scientific community, a growing openness to collaboration with industry, and access to a European patient database. Considering the remarkable progress that…

Europe Rainer Westermann of venture capitalist coalition Life Sciences Acceleration Alliance reviews the potential impact of the EU’s general pharmaceutical legislation on the investment climate for the EU life sciences sector. Building on his insights from last year, Westermann urges stakeholders to seize the opportunity caused by a delay in the…

Switzerland For the Swiss Agency for Therapeutic Products (Swissmedic), one of the world’s leading regulatory authorities, 2023 was an important year. Not only did the agency gain recognition from the World Health Organisation (WHO), Swissmedic also saw a Good Manufacturing Practice (GMP) agreement between Switzerland and the US FDA come into…

Portugal Paula Barriga, VP & GM at Novo Nordisk Portugal, discusses the high prevalence of obesity, which affects over two million people in a country where none of the available pharmacological obesity treatments are currently reimbursed and where access to innovation is slow by European standards. She explains the need for…

CEE Some of the biggest stories coming out of the Central and Eastern European (CEE) region’s pharma industry, including the European Bank’s EUR 25 million investment in Pelion Group; the amendments to Poland’s drug reimbursement act; Pfizer’s legal proceedings against Hungary, Poland and Romania, and Egis Pharma’s expansion beyond Hungary.  …

Europe Obesity is pharma’s new El Dorado. Following the spectacular market success and sky-high sales projections of next-generation obesity treatments, many actors – both large and small – are looking to carve out a slice of this huge growth market. Those who made a bet on obesity years in advance are…