EU PERSPECTIVES - The EU is promising to speed up the approval of medical devices. For innovative companies, this could mean less waiting and greater certainty. Or perhaps not. "When you start the certification process now, you don't know what to expect. It can take two years or even more. That is killing the market opportunities," says...

EU PERSPECTIVES - Access to treatment for rare diseases still depends heavily on where you live. While patients in larger EU Member States receive new medicines within a year or two, others may wait up to four years – if they get them at all. The European Parliament now wants to turn solidarity rhetoric into a concrete...

EU PERSPECTIVES - Europe invested more than €1.8bn in pandemic preparedness research after 2020. Yet when Covid-19 struck, clinical trials fragmented, infrastructures operated in parallel, and promising discoveries failed to translate into deployable countermeasures. The problem was not scientific capacity, says Hervé Raoul, coordinator of the...

EU PERSPECTIVES - Cyprus's proposal for a new European Centre of Clinical Excellence for Pharmaceuticals has entered Europe's health policy debate. The presidency frames it as a tool to strengthen scientific coordination without encroaching on national competences. Read more

EU PERSPECTIVES - The European Parliament's health rapporteur has publicly questioned whether the purpose of the EU's proposed European Competitiveness Fund (ECF) is to serve health policy or industrial strategy. His remarks expose deeper uncertainty about the fund's core purpose. Read more

EUROPEAN BIOTECHNOLOGY MAGAZINE - GSK will pay $950m for Montreal-based 35Pharma to secure HS235, an investigational activin signalling inhibitor that has completed Phase I trials in healthy volunteers and is set to begin studies in pulmonary arterial hypertension (PAH) and pulmonary hypertension due to heart failure with preserved...

EUROPEAN BIOTECHNOLOGY MAGAZINE - argenx delivered two significant updates on the same day: positive Phase 3 results in ocular myasthenia gravis (oMG) and its first full year of operating profitability. Together, the announcements show a company expanding its lead medicine into a new patient population while doing so from a position of...

EUROPEAN BIOTECHNOLOGY MAGAZINE - A group of vaccine developers, biotech firms and public health institutes, including Bavarian Nordic and Sanofi, has secured framework contracts under a €225 million EU initiative to accelerate the development of next-generation influenza vaccines. Read more

EUROPEAN BIOTECHNOLOGY MAGAZINE - Cambridge, UK-based Syndex Bio has announced on Monday the introduction of its proprietary mcPCR™ (methyl-copying PCR) platform at the Advances in Genome Biology and Technology (AGBT) meeting in Orlando, Florida, alongside the close of an oversubscribed $15.5 million seed financing round led by ARCH...

EURACTIV - As the EU Pharma Package enters implementation, Roche Belgium argues that reform alone will not secure Europe's competitiveness unless regulatory frameworks evolve to accommodate new technologies. Read more