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.
Swiss 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.
Berlin-based OMEICOS Therapeutics can move OMT-28 directly into a pivotal Phase 3 trial in primary mitochondrial diseases after receiving supportive feedback from the U.S. Food and Drug Administration (FDA).
adobe stock photos - Michael Derrer Fuchs Novartis has discontinued development of Lu-NeoB, an experimental radioligand therapy targeting the gastrin-releasing peptide receptor, after early clinical data failed to support further development.