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BioWorld - Monday, June 22, 2026
Home » Topics » Regions » Europe

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White Euro symbol on blue background

European VCs bullish on med-tech investments in 2025

Feb. 13, 2025
By Shani Alexander
European companies looking for capital should find the fundraising environment more favorable in 2025. Private med-tech financings in January totaled about $2 billion, more than double from last year, and the venture capital firms on the continent have the funds available to pursue investment opportunities.
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Ziwig Endotest

France grants Ziwig Endotest fast-track reimbursement

Feb. 13, 2025
By Annette Boyle
Ziwig SAS, which leads the race for a simple diagnostic for endometriosis, picked up the pace with a fast-track reimbursement decision in France for its Endotest, the first saliva-based diagnostic assay for endometriosis.
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Business people with hands atop a digital globe

APAC deals abound: Lilly taps Advancell, Olix; Genome draws Ellipses

Feb. 12, 2025
By Marian (YoonJee) Chu
Dealmaking in the Asia Pacific (APAC) region took off this week, with the latest showcasing Genome & Co.’s licensing deal with Ellipses Pharma Ltd. for GENA-104, a phase I-ready immuno-oncology asset, under undisclosed terms Feb. 11.
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European Union flag with wooden gavel

EC drops AI liability directive for now

Feb. 12, 2025
By Mark McCarty
The European Commission’s proposal for an AI-specific liability law seemed destined to pile onto existing EU liability law, but the commission reported it will pull the legislative proposal dubbed the AI Liability Directive.
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Henlius lands European approval of PD-1 lung cancer drug

Feb. 11, 2025
By Marian (YoonJee) Chu
The European Commission on Feb. 5 cleared Shanghai Henlius Biotech Inc.’s serplulimab (HLX-02) under the brand name of Hetronifly as a first-line combination therapy with carboplatin and etoposide to treat extensive-stage small-cell lung cancer.
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Shipping container with flag of China

Speculations rise on US tariff impact on global pharma industry

Feb. 11, 2025
By Marian (YoonJee) Chu
For the pharmaceutical industry caught in the crosshairs of a potential trade war, the consequences of U.S. tariffs on China or Europe remain largely speculative, although both would be detrimental, according to a Korea Biotechnology Industry Organization (KoreaBIO) issue briefing Feb. 7.
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DBS for stroke

Newronika gets IDE from the FDA for adaptive DBS trial

Feb. 11, 2025
By Shani Alexander
Newronika SpA's AlphaDBS recently secured an investigational device exemption from the U.S. FDA allowing it to begin a pivotal trial to evaluate the safety and efficacy of its adaptive deep brain stimulation system in patients with movement disorders, including Parkinson's disease.
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Artificial intelligence and digital health icons

European Commission provides guidance for AI Act

Feb. 11, 2025
By Mark McCarty
The European Commission issued a set of guidelines for the use of AI as a supplement to the EU’s Artificial Intelligence Act, a document of which chatbot developers will want to take note.
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United Kingdom flag, map

NICE to revisit its cost savings approach to health tech assessment

Feb. 11, 2025
By Mark McCarty
The U.K.’s National Institute for Health and Care Excellence (NICE) historically relies on cost savings to vet novel medical technologies, but that may soon change per a Feb. 7 announcement.
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Squamous cell carcinoma.

Skin Analytics DERM gets CE mark for autonomous cancer detection

Feb. 10, 2025
By Shani Alexander
Skin Analytics Ltd. received CE mark for its AI-based tool Deep Ensemble for the Recognition of Malignancy (DERM), which can assess images of lesions and detect skin cancer autonomously. The technology has an accuracy rate of 99.8% compared to 98.9% for dermatologists.
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