On 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 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).
Berlin-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.
Italian 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.
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.
Belgian-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.
Spanish 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 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.
Newly 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.
German 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.