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BioWorld - Monday, June 29, 2026
Home » Topics » Regions » Europe

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Valneva vaccine vials

Regulatory submissions ahead on solid phase III data for Valneva’s COVID-19 vaccine

Oct. 18, 2021
By Nuala Moran
LONDON – Valneva SA’s COVID-19 vaccine, VLA-2001, prompted a stronger immune response with fewer side effects than Astrazeneca plc’s product, according to headline data from the phase III trial. Shares in Valneva (NASDAQ:VALN) shot up by nearly 40% to close Oct. 18 at $39.21 when the data were announced, partly repairing the damage on Sept. 13 when the U.K. government cancelled a $1.65 billion contract with the French vaccines specialist for 100 million doses.
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Illustration of ECG use (multilead and unilead) in training and testing the deep CNN models up to the prediction of a risk score and evaluation by the physician.

Deep learning ECG analysis may predict risk of drug-induced arrhythmia

Oct. 15, 2021
By Bernard Banga
PARIS – Teams from the Pitié-Salpêtrière hospital, the Institute for Research in Development, Sorbonne University and the National Institute of Health and Medical Research are proposing a new technique that uses artificial intelligence (AI) to identify the risk of developing a type of cardiac arrhythmia called Torsades de pointes (TdP) associated with taking certain drugs.
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Pediatric brain illustration

Synaptixbio sets off on quest to find therapy for rare CNS disease

Oct. 15, 2021
By Richard Staines
U.K.’s Synaptixbio Ltd. has launched, aiming to tackle a rare and often fatal disease of the central nervous system (CNS), TUBB4a leukodystrophy.
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Apellis chalks up positive opinion in Europe for rare blood disorder drug

Oct. 15, 2021
By Nuala Moran
LONDON – The EMA recommended approval of Apellis Pharmaceuticals Inc.’s C3 complement inhibitor, Aspaveli (pegcetacoplan), to treat paroxysmal nocturnal hemoglobinuria, but has diverged from the FDA, excluding treatment-naïve patients adding its use should be restricted to those who have failed to respond to C5 inhibitor drugs.
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European Union flag

European Commission proposes additional year for IVDR implementation

Oct. 14, 2021
By Mark McCarty
The shortage of European notified bodies (NBs) for in vitro diagnostics has prompted calls from industry to delay the compliance dates for the In Vitro Diagnostic Regulation (IVDR), and the European Commission has responded with a proposed fix. The Commission proposed to give IVDs that are already on the market until May 2025 or later to obtain new CE marks, but the change requires the assent of the European Parliament and the European Council before it goes into force.
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Brain with handshake and cityscape

Scotland signs Big deal to make mental health digital therapy available nationally

Oct. 14, 2021
By Catherine Longworth
The Scottish government has signed a deal with digital therapeutics company Big Health Inc. to make a cognitive behavior therapy (CBT) platform for anxiety and insomnia available through the NHS. It makes Scotland the first country to provide a digital therapeutic for anxiety and insomnia nationally.
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Hands holding gears

BIA Autumn Forum: Keep collaboration, innovation momentum post-pandemic, new UK science minister urges

Oct. 14, 2021
By Nuala Moran
LONDON – After the hard, solitary slog through months of pandemic, U.K. biotech finally convened in person, buoyed by the contribution the sector has made to dealing with COVID-19, and evidently pleased to be face-to-face once more.
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Photo of Hugo platform components

Medtronic gears up to commercialize Hugo robotic system in Europe

Oct. 12, 2021
By Catherine Longworth
Medtronic plc’s Hugo robotic-assisted surgery system has received a CE mark for urologic and gynecologic procedures, paving the way for commercialization in Europe. The approval is a key milestone for the Dublin-headquartered company, following the launch of Hugo in Latin America and India. The company is prioritizing robotics as a major growth opportunity, but will face tough competition in the space as it goes head-to-head with established market leader Intuitive Surgical Inc. According to Medtronic, Europe could provide a significant opportunity due to its current low uptake of surgical robotic procedures.
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Curevac vial

Curevac quits early COVID-19 vaccine program to work on next-gen candidate, scrubbing EC purchase agreement

Oct. 12, 2021
By Michael Fitzhugh
Curevac AG, once a forerunner in COVID-19 vaccine development but later surpassed, said it would terminate its first effort in the field, CVnCoV, withdrawing it from a rolling review at the EMA to focus instead on development of second-generation mRNA vaccine candidates with Glaxosmithkline plc.
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Dollar sign at center of maze

Mindmaze scores big with $125M for gamified neurotherapeutics platform

Oct. 11, 2021
By Annette Boyle
Mindmaze SA raised $125 million in a debt financing round led by Albacore Capital Group to expand its virtual reality-based digital neurotherapeutics platform. Total funding for Mindmaze now exceeds $235.7 million to date. Investors include the Hinduja Group, Venture Kick, the Foundation for Technological Innovation, and Leonardo DiCaprio. The Mindmaze platform assesses and restores cognitive and motor function in individuals who have sustained neural injuries or impairment from degeneration and aging.
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