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BioWorld - Sunday, May 31, 2026
Home » Topics » Regions » Europe

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Gears with regulatory words

Trio of regulators issues guidelines for transparency for AI

June 17, 2024
By Mark McCarty
For the third time in as many years, Health Canada, the U.S. FDA and the UK Medicines and Health Care Products Regulatory Agency have teamed up to issue a set of recommendations for artificial intelligence used in or as a medical device.
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British and U.S. flags

UK, US authorities sign MOU for standard essential patents

June 14, 2024
By Mark McCarty
Even patent attorneys aren’t particularly collectively excited about standard essential patents, but that hasn’t stopped the U.S. Patent and Trademark Office from signing a memorandum of understanding with the U.K. Intellectual Property Office to collaborate on policies related to these patents.
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Atkiia co-founders holding product box

Aktiia receives CE mark for calibration-free blood pressure system

June 14, 2024
By Shani Alexander
Aktiia SA recently received a CE mark for Calfree, its optical blood pressure monitoring technology that does not require calibration with a traditional cuff. The Calfree system can be integrated into a wide range of third-party devices, significantly improving hypertension management and as a result the quality of patients’ lives.
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NLRP3 inflammasome

Nodthera's NLRP3 inflammasome inhibitor targets cardiometabolic space

June 12, 2024
By Nuala Moran
After delivering animal data to show that inhibiting the NLRP3 inflammasome induces weight loss in mice, Nodthera Ltd. has now demonstrated this effect translates to humans. In a phase Ib/II study of NT-0796, an orally available, brain-penetrant drug, subjects in both the active and placebo arms all lost weight, due to the calorie-restricted diet they received in the 28-day trial.
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Startup key, rocket icon
Newco news

Adcytherix aims for innovation as startup in crowded ADC space

June 11, 2024
By Nuala Moran
Fresh from the sale of one antibody-drug conjugate (ADC) company, Jack Elands has formed another, raising €30 million (US$32.2 million) in seed funding for Adcytherix SAS. The newco brings together the same cast as Elands’ former company, Emergence Therapeutics, which was sold to Eli Lilly and Co. for an undisclosed sum in a deal that closed in August 2023.
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Amber Implants Vcfix

Amber Implants sees promising results from patients treated with Vcfix spinal system

June 11, 2024
By Shani Alexander
Amber Implants BV reported promising results from the first-in-human trial of patients fitted with its Vcfix spinal system which treats vertebral compression fractures. Data showed that patients experienced significant pain relief and regained the ability to walk without discomfort.
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Amber Therapeutics Picostim system

Amber Therapeutics raises $100M for bio e-stim for urinary incontinence therapy

June 10, 2024
By Shani Alexander
Amber Therapeutics Ltd. has raised $100 million in a series A funding round to further develop its implantable closed-loop bioelectrical therapy to treat women suffering from mixed urinary incontinence. The financing is one of the largest series A rounds ever seen in Europe’s medical technology space and comes at a time when many med-tech companies are struggling to raise funds.
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microvesicles patent
Patents

Demcon combines FUS, microbubbles to deliver drugs across blood-brain barrier

June 10, 2024
By Simon Kerton
In what represents its first patenting Demon Curonix BV is seeking protection for a system for providing microvesicles to be used in combination with focused ultrasound for drug delivery to the brain.
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Art concept for targeting a cold tumor

Marengo’s TriSTAR technology attracts second Ipsen deal for $1.2B

June 7, 2024
By Karen Carey
Two years after signing a $1.6 billion partnership with Marengo Therapeutics Inc., Paris-based Ipsen SA is back at it again, this time teaming up for two additional assets that target “cold” tumors in a deal that could bring privately held Marengo $1.2 billion. “We do something really novel and innovative and I think it’s very important to continue to validate it,” Marengo CEO Zhen Su told BioWorld, adding that with the newest deal, “we see validation all around this … It’s a success on success.”
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ITM Mode-of-Action

ITM raises €188M for radiopharmaceutical pipeline

June 6, 2024
By Shani Alexander
Isotope Technologies Munich SE (ITM) raised €188 million ($204 million) in a funding round that will largely be used to advance and expand the company’s radiopharmaceutical pipeline. The funds, which come a year after ITM raised €255 million, are a sign of growing investor interest in the company’s products and the radiopharma market, Steffen Schuster, CEO of ITM, told BioWorld.
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