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.
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.
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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.
OMEICOS takes repurposed drug directly into Phase 3
Latest NewsBerlin-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).
Novartis drops Phase 2 radioligand therapy
Latest NewsNovartis 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.