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.
Pharmanovia licenses China-approved PARP drug for up to €423.5M
Latest NewsUK specialty pharma Pharmanovia has licensed senaparib, IMPACT Therapeutics’ oral PARP1/2 inhibitor, across 66 countries in a deal worth up to €423.5 million.
Relation deepens GSK alliance with $110M deal
Latest NewsLondon-based Relation Therapeutics has expanded its research collaboration with GSK in an agreement worth up to $110 million (€97 million), as the AI biotech launches a foundation model designed to predict how human cells respond to experimental treatments.
Sanofi axes two more inflammatory-disease drugs
Latest NewsSanofi has discontinued development of itepekimab and balinatunfib after disappointing clinical results, ending ongoing programmes across respiratory and inflammatory diseases.
CHMP backs first CETP inhibitor after two decades of failure
Latest NewsOn July 23, Europe’s Committee for Medicinal Products for Human Use (CHMP) recommended the CETP inhibitor obicetrapib for approval after a string of big-name Phase 3 failures over the past two decades. The European Commission’s final approval is expected in the second half of the year.
GSK announces plan to axe UK Stevenage R&D hub, moving to Cambridge
Latest NewsGSK has announced plans to shut its UK R&D headquarters in Stevenage, UK, moving operations north to a new site in Cambridge, while also announcing a company-wide programme to reduce annual costs by £1.9 billion (€2.2 billion).
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.