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BioWorld - Sunday, February 5, 2023
Home » Topics » Regions » Europe

Europe
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Various screenshots of software showing retinal images

Eyenuk wins EU approval to market its AI screening system

Feb. 2, 2023
By Nuala Moran
No Comments
Eyenuk Inc. is significantly extending the scope of its artificial intelligence system for the automatic analysis of retinal images, adding the diagnosis of age-related macular degeneration (AMD) and glaucoma to the EU approved uses of Eyeart AI.
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Transition period over: EMA’s new clinical trials system in place

Jan. 31, 2023
By Nuala Moran
No Comments
It is a “landmark moment” in the long-awaited upgrade of the management of clinical research in Europe, but the industry has given a lukewarm welcome to a mandate to submit all clinical trial applications via the EMA’s clinical trials information system, as of Jan. 31.
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Handshake, businessmen holding dollar sign, lightbulb
Remote health monitoring

Maela and Nouveal merge, raising $6.5M to become a leading telemedicine player in France

Jan. 30, 2023
By Bernard Banga
No Comments
Maela SAS and Nouveal SAS reported plans to merge and become a leading player in the market for remote medical monitoring and patient pathway management.
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Royal Philips headquarters

Philips slices 10,000 jobs in wake of respiratory product recall, loss for the quarter

Jan. 30, 2023
By Annette Boyle
No Comments
Royal Philips NV revealed plans to cut a further 6,000 jobs on top of the 4,000 announced in October as it sought to stabilize the business and improve its operational performance going into 2023. In total, the company will reduce its workforce by about 13%. Philip’s fourth quarter results came in ahead of consensus expectations, but the company still posted a loss of €105 million (US$108.2 million).
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UK’s NICE leaning in on real-world evidence in tech assessments

Jan. 27, 2023
By Mark McCarty
No Comments
Real-world evidence (RWE) is all the rage in med-tech circles, given the promised efficiencies, but the U.K. National Institute for Health and Care Excellence is especially dialed in on RWE. The agency recently announced that it will expand its use of RWE to include health technology assessments (HTAs), promising a slightly less drag-filled path to clinical adoption in one of the world’s most robust markets.
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The 2022 UK Biotech Financing report: IPOs dropped but venture cap stood strong

Jan. 27, 2023
By Lee Landenberger
No Comments
It’s been a tough year for raising biotech money, according to the new U.K. Biotech Financing Report, but there are bright spots in an otherwise dark period. What happened last year in the U.K. basically mirrored what happened with global financings as IPOs are significantly down while venture capital rounds stood strong.
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Dupixent

EMA says yes to Sanofi/Regeneron’s dermatitis drug, no to Ipsen’s bone disease contender

Jan. 27, 2023
By Caroline Richards
No Comments
Where European regulatory decisions were concerned, there was good news and bad news for pharma today as Sanofi SA and Regeneron Pharmaceuticals Inc. got the go-ahead for expanded approval of Dupixent (dupilumab) in pediatric atopic dermatitis patients whilst Ipsen SA’s ultra-rare bone disease drug palovarotene was left off the shelf as efficacy data failed to impress.
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Amber Therapeutics reports first implants of UI bioelectrical stimulation device

Jan. 26, 2023
By Nuala Moran
No Comments
Amber Therapeutics Ltd. reported that three patients have been fitted with its closed loop bioelectrical stimulation device, which it says is the first to modulate the pudendal nerve to directly address urinary continence (UI).
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Da Vinci Xi robot - Intuitive Surgical

Da Vinci robot-assisted auto-transplantation performed for renal cancer

Jan. 26, 2023
By Bernard Banga
No Comments
A French surgical team has performed a robot-assisted kidney auto-transplantation with ex situ tumorectomies for renal cell cancer. This is the world first use of the fourth generation Da Vinci Xi surgical robot from Sunnyvale, Calif.-based Intuitive Surgical Inc. to perform kidney explanation and autotransplantation with removal of multiple and complex tumors outside of a patient's body.
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NICE adds study results for insulin pumps to cost effectiveness evaluation

Jan. 24, 2023
By Nuala Moran
No Comments
A U.K. real world nationwide study of the clinical effectiveness of hybrid close loop (HCL) insulin administration systems has found they improve glycemic control in type 1 diabetes compared to the earlier generation of devices.
Read More
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