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BioWorld - Tuesday, December 23, 2025
Home » Topics » Regions » Europe

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Directstim device image

Aleva launches postmarket study on its directional DBS system for neurology conditions

July 16, 2021
By Bernard Banga
PARIS – Aleva Neurotherapeutics SA reported the first successful implantation of its Directstim directional deep brain stimulation (DBS) system into a patient suffering from Parkinson’s disease. The procedure involving this new generation of active brain device was performed by neurosurgeon Stephan Sobottka, from the Clinic for Neurosurgery at the University Hospital Carl Gustav Carus in Dresden, Germany.
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Patient in hospital bed

Not just the elderly: UK study shows COVID-19 complications affect younger patients, too

July 15, 2021
By Nuala Moran
LONDON – The message that COVID-19 is a disease of the elderly needs to change, according to U.K. researchers who have analyzed complications suffered by 73,197 patients admitted to 302 hospitals in the first wave of the pandemic last year.
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Reichstag, German parliament building in Berlin

U.S. lawmakers pressure Germany on WTO IP waiver

July 14, 2021
By Mari Serebrov
Hoping to get Germany to drop its opposition to a proposed World Trade Organization (WTO) waiver of intellectual property (IP) rights, several U.S. lawmakers have asked to meet with German Chancellor Angela Merkel when she’s in Washington for a July 15 summit with President Joe Biden.
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IPO, coins, financial chart
Newco news

Poolbeg Pharma takes ‘AIM’ at flu with $35M IPO in London

July 14, 2021
By Cormac Sheridan
DUBLIN – Poolbeg Pharma plc raised £25 million (US$35 million) in an IPO on London’s Alternative Investment Market (AIM) to pursue development of antiviral drugs. The company priced the offering at 10 pence per share, which implies a valuation of £50 million. Shares are due to commence trading on Monday, July 19.
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Politicians and pressure groups push back against Philip Morris’ Vectura acquisition

July 14, 2021
By Richard Staines
It’s more than 20 years since the tobacco firm Philip Morris International Inc. commissioned a controversial research paper, “Public Finance Balance of Smoking in the Czech Republic,” which infamously argued that smokers cut state health care expenditure by dying early. The paper was considered an outrage and led to a high-profile apology from the company, after being widely derided by politicians and commentators internationally. The company’s July 9 proposal to buy the respiratory diseases firm Vectura Group plc for $1.2 billion is already looking just as provocative according to U.K. politicians and anti-smoking groups, who are calling for the government to intervene to stop it going ahead.
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European Commission headquarters

EC issues guidance on EU IVDR codes to offset NB burden

July 13, 2021
By Ana Mulero
The European Commission (EC) posted a new explanatory note on Tuesday that provides guidance on the codes set under the European In Vitro Diagnostic Regulation (IVDR) to define the notified body (NB) scope of designation and qualification required for assessing a device. The clarifications explain how to use the different levels of codes to guide the proper allocation of resources, citing the anticipated challenges with limited experience and competency of NBs.
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Clinical trial virtual display

Academics call for fixes to Europe’s spotty clinical trial registry

July 13, 2021
By Richard Staines
Europe’s clinical trial registry is a mess with patchy and incomplete data, according to a scathing review of the system from researchers based at the U.K.’s University of Oxford, who hope that a revamp at the end of the year could improve matters.
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07-09 Kiomed-1-b-hero pic

Kiomed partners with Moveup to market a soft implant for pain in knee OA

July 9, 2021
By Bernard Banga
PARIS ‒ Kiomed Pharma SA reported it has signed an exclusive agreement with fellow Belgian company, Moveup SA for the development and licensing of a mobile companion application intended for personalized conservative management treatment for patients suffering from intra-articular osteoarthritis.
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NICE rejects Orchard’s rare disease drug, but Zolgensma U-turn offers hope

July 9, 2021
By Richard Staines
NICE has said “no” to regular NHS funding for a rare disease gene therapy from Orchard Therapeutics Ltd. in draft guidance – although experience from Novartis AG’s pricey Zolgensma (onasemnogene abeparvovec) for spinal muscular atrophy shows this could change. That’s because this week NICE published final guidance that recommends funding for Zolgensma, thought to be the world’s most expensive drug, after an initial rejection late last year.
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U.K. flag on stethoscope

UK adjusts to ‘the new norm’ with updated life sci policies, £1B commitment

July 7, 2021
By Nuala Moran
LONDON – The U.K. intends to take the positives from its response to the COVID-19 pandemic as a blueprint for developing treatments for a range of other diseases and the basis for a new 10-year strategy for the life sciences.
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