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BioWorld - Friday, July 17, 2026
Home » Topics » Regions » Europe

Europe
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Aduhelm product image

Biogen withdraws EU Aduhelm filing amid announcement of latest CHMP opinions

April 22, 2022
By Richard Staines
Biogen Inc. has given up on its attempt to get its Alzheimer’s disease drug Aduhelm (aducanumab) approved by regulators in Europe, deciding to withdraw its filing midway through a review of a previous rejection. The company had asked the European Medicines Agency’s CHMP to reconsider its negative opinion for Aduhelm in December 2021. But its subsidiary in the Netherlands wrote to the EMA this week saying that it had decided to withdraw its marketing authorization application after all.
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Cairdac's device

Cairdac raises $18.5M in funding to develop self-powering leadless pacemaker

April 18, 2022
By Bernard Banga
Cairdac SAS closed its first funding round, raising nearly $18.5 million to increase development of an autonomous, leadless pacemaker transcatheter system (ALPS) powered entirely using kinetic energy from the heart. Five French private equity funds and banks participated in this series A round.
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Valneva vaccine vials

Dumped by UK government, Valneva turns to Scotland as regulator approves COVID-19 shot

April 14, 2022
By Richard Staines
The U.K.’s drugs regulator has approved the COVID-19 vaccine from Valneva SE – although the shot is likely only to be offered to health workers in Scotland after the Westminster government rejected it because rivals beat it to market.
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Map of Europe, Medical Device Regulation (MDR) text

France and Germany warn of collapse in patient care unless MDR transition period extended

April 13, 2022
By Bernard Banga
The German Medical Technology Association, BVMed, and the French medical technology industries association, SNITEM, have issued a joint warning highlighting the risk of collapse in patient care throughout the EU.
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Pill bottles, blister packs in a package

Northern Ireland drug supply secured with latest Brexit solution

April 12, 2022
By Mari Serebrov
Making it a done deal, the European Council adopted proposals April 12 to ensure the continued long-term supply of medicines from Great Britain to Northern Ireland and to address supply concerns in Cyprus, Ireland and Malta, which historically have been dependent on drugs from the U.K.
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Antibiotic-capsules-in-blister-packs.png

Pfizer, Shionogi antibiotics in first guidance for UK fixed-fee plan

April 12, 2022
By Nuala Moran
The U.K. plan to fix the market failure in antibiotics has taken a significant step forward with the publication of guidance estimating the value of two drugs to the National Health Service.
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Engitix’s ECM platform adds IBD effort in $300M expanded Takeda deal

April 12, 2022
By Nuala Moran
Takeda Pharmaceutical Co. Ltd. has stress-tested Engitix Ltd.’s extracellular matrix (ECM) drug discovery platform and is coming back for more, expanding the existing collaboration from liver fibrosis to inflammatory bowel disease (IBD).
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Close-up of eye with digital focus

Meduni Vienna develops eye scanner for detecting early-stage neurodegenerative conditions

April 11, 2022
By Bernard Banga
Meduni Vienna, the Medical University of Vienna, Austria, is working on a novel eye scanner combining the structural and functional sensitivity of optical coherence tomography (OCT) with the chemical specificity of Raman spectroscopy, to acquire data from the living human eye.
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EU flag, pills, syringe

Biopharmas aim to remedy access disparities across EU

April 11, 2022
By Mari Serebrov
The biopharma industry signed on to a new pledge to increase the availability of innovative drugs across the EU and shave months from the time patients in some EU member states must wait for access to new drugs. Members of the European Federation of Pharmaceutical Industries and Associations committed to file for pricing and reimbursement in all EU countries as soon as possible and no later than two years after receiving central EU market authorization – if local systems allow it.
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Cancer cell and DNA

C2i reports European launch of its minimal residual disease diagnostic

April 8, 2022
By Nuala Moran
C2i Genomics Inc. reported the formal launch of its C2inform minimal residual disease diagnostic across Europe, after obtaining CE marking for the cancer test. The Cambridge, Mass.-based company also has completed several clinical trials it ran with research partners to validate the technology and will be presenting data in different cancers at the American Association for Cancer Research in New Orleans, April 8-13.
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