Launched in 2022, the EU Clinical Trials Information System (CTIS) aims to streamline and centralise the process of applying for clinical trial authorisation, but has also increased typical approval timelines. Several nations are now introducing accelerated pathways that jump the queue, offering one of the fastest routes to the clinic in the world for companies navigating this increasingly complex regulatory landscape.
Pentixapharm raises €20.4M for Phase 3 diagnostic trial
Latest NewsBerlin-based Pentixapharm Holding AG has raised about €20.4 million to fund a pivotal Phase 3 trial of its PET diagnostic PentixaFor and advance its CXCR4-targeted theranostics pipeline.
Chiesi retreats from Gossamer PAH programme after Phase 3 miss
Latest NewsItalian pharmaceutical group Chiesi has returned all development and commercial rights to seralutinib to Gossamer Bio, ending a pulmonary arterial hypertension partnership originally valued at up to $486 million.
Fast-track trial approval: a way to jump the EU queue?
Background, Latest NewsLaunched in 2022, the EU Clinical Trials Information System (CTIS) aims to streamline and centralise the process of applying for clinical trial authorisation, but has also increased typical approval timelines. Several nations are now introducing accelerated pathways that jump the queue, offering one of the fastest routes to the clinic in the world for companies navigating this increasingly complex regulatory landscape.
argenx pays $2.2B for Forte’s early autoimmune promise
Latest NewsBelgian-Dutch immunology company argenx has agreed to acquire Forte Biosciences for $2.2 billion (€1.9 billion), gaining FB102, an early-stage antibody that has already produced efficacy signals in vitiligo and celiac disease.
BIO-Europe 2026
Sponsored PublicationsJoin us for the 2nd BIO-Europe in Cologne, Germany, November 9–11, 2026, the premier biopharma partnering event now transformed into a comprehensive forum for biotech leaders.
CHMP backs Minoryx’s rare disease drug two years after rejection
Latest NewsSpanish biotech Minoryx Therapeutics has secured a positive European regulatory opinion for Nezglyal, two years after regulators rejected an earlier application for the rare neurodegenerative disease drug.
Sanofi drops eczema drug from $1.1B Kymab deal
Latest NewsSanofi has ended the development of amlitelimab in atopic dermatitis and will not seek regulatory approval for the drug, concluding that it would not meaningfully improve on existing treatments.
Iceland-based Synaptiq launches with Nobias’ rare disease drug
Latest NewsNewly formed Synaptiq Therapeutics has acquired substantially all the assets of Nobias Therapeutics, including a clinical-stage drug whose development has already spanned several companies and more than three decades.
Fresenius launches €200M healthcare venture fund
Latest NewsGerman healthcare group Fresenius has created a corporate venture capital unit that plans to invest more than €200 million in healthcare startups over the next five years.
Neurimmune turns future royalties into $425m pipeline cash
Latest NewsSwiss biotech Neurimmune has sold part of its future royalties from its AstraZeneca-partnered experimental heart drug cliramitug to Royalty Pharma for up to $425 million, giving it fresh cash to invest in its remaining antibody pipeline.