Tagged with europe

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…

Denmark In conversation at DIA Europe 2024 in Brussels, Lars Bo Nielsen lays out the digital transformation that the Danish Medicines Agency has undergone over the past three years and how AI can best be integrated into the work of national regulatory bodies.   What does AI really mean? How can…

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)…

Portugal Novo Nordisk’s spectacular ascendancy in 2023 has meant that its country managers across the world have had to embrace scrutiny and press coverage like never before.   In its centenary year, the Danish firm’s new generation of obesity drugs supercharged revenues to around EUR 30 billion, a 30 percent hike…

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…