Tagged with EU

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…

LatAm A roundup of some of the latest stories coming out of Latin American pharma and healthcare, including Merck’s new distribution centre in Brazil; the region’s record dengue surge; Roemmers Laboratory’s acquisition of 30% of Argentina’s Tuteur, and Urufarma’s new manufacturing facility in Uruguay.   Merck to open new distribution centre…

India India’s National Chemical Laboratory (NCL), one of the most well-established labs in the wider Council of Scientific and Industrial Research (CSIR) network, has made some major contributions to improving the country’s manufacturing processes for pharmaceutical intermediates and APIs. Director Dr Ashish Lele outlines the approaches the lab is pursuing, such…

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)…

Switzerland The biggest pharma news from Switzerland, including the industry’s cautious reaction to a new free trade deal with India; the drop in Roche’s share prices; Novartis’ acquisiton of MorphoSys, and the licence agreement between EraCal Therapeutics and Novo Nordisk.   Swiss industry welcomes agreement with India, pharma more cautious (Le…

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…

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…