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BioWorld - Wednesday, April 29, 2026
Home » Topics » Regions » Europe

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Syringe, bottles of COVID-19 vaccine on U.K. map

U.K. is first country to approve Pfizer/Biontech’s COVID-19 vaccine

Dec. 8, 2020
By Nuala Moran
LONDON – The first of 800,000 commercial doses of Pfizer Inc./Biontech SE’s COVID-19 vaccine arrived in the U.K., after the Medicines and Healthcare products Agency (MHRA) became the first regulator to grant conditional approval. A total of 1,500 immunization centers in the U.K. are preparing to receive the vaccine, with administration beginning Dec. 8.
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Person using virtual reality equipment
Digital therapeutics

Lucine Therapeutics raises $6.6M to treat chronic pain using its digital therapy

Dec. 7, 2020
By Bernard Banga
PARIS – Lucine Therapeutics SAS has raised $6.6 million to finance development of its first digital therapy aimed at relieving chronic pain. A 100% French initial funding round, six French funds have contributed to this seed fund.
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Heart, implant illustration

Researchers are working on a new implant for minimally invasive mitral valve repair

Dec. 3, 2020
By Bernard Banga
PARIS – Researchers at the Biomechanics and Bioengineering laboratory (BMBI), a joint venture between the Compiègne University of Technology in Oise, France, and the National Center for Scientific Research (CNRS), have designed a new implant intended for minimally invasive surgery for mitral valve repair. One of the BMBI teams has been working closely two cardiovascular surgeons from the University Hospital of Henri-Mondor to develop this new minimally invasive approach in the treatment of mitral valve regurgitation.
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Device image

Livanova agrees to sell heart valve business to Gyrus Capital

Dec. 3, 2020
By Liz Hollis
Livanova plc has inked an agreement with Gyrus Capital SA to divest its heart valve business. The sale has an enterprise value of €60 million (US$73 million) and is expected to wrap up in the first half of next year. The Livanova board has already given its unanimous assent for the deal. Livanova now expects to strengthen its focus on its neuromodulation and cardiovascular platforms.
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Regulatory front

FDA posts combo product feedback final guidance

Dec. 3, 2020
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: New notified body for IVDs brings total to five; U.S. securities compliance not optional for foreign companies; USPTO touts early results of amendment pilot.
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Syringe, bottles of COVID-19 vaccine on U.K. map

U.K. is first country to approve Pfizer/Biontech’s COVID-19 vaccine

Dec. 2, 2020
By Nuala Moran
LONDON – The first 800,000 commercial doses of Pfizer Inc./Biontech SE’s COVID-19 vaccine are due to arrive in the U.K. over the next few days, after the Medicines and Healthcare products Agency (MHRA) became the first regulator to grant conditional approval. A total of 1,500 immunization centers in the U.K. are preparing to receive the vaccine, with administration now expected to start on Monday, Dec. 7.
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Device closeup

Corwave secures grant for its manufacturing facility

Dec. 1, 2020
By Bernard Banga
PARIS – Corwave SA has obtained $600,000 as part of the Ile-de-France region's stimulus plan, to boost development of its Neptune cardiac support pump. This subsidy is part of the manufacturing recovery plan for the Ile-de-France region, aimed at very small enterprises (VSEs), small and medium-sized enterprises (SMEs) and mid-cap companies. In the midst of the COVID-19 pandemic, the Ile-de-France Region is supporting re-industrialization in a region that brings together 12.1 million inhabitants, or nearly 19% of the French population.
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Smartphone screen with test results

Salient Bio rolls out fast, cheap, accurate PCR COVID-19 test

Dec. 1, 2020
By Annette Boyle
Salient Bio launched a robotics-driven PCR test for COVID-19 with 99% for use in mass testing for the virus. The company says the "fastest ever" test notifies users of test results in less than a day and is priced to be cost effective for businesses. Salient plans to expand the number of tests utilizing the modular diagnostics platform in 2021 to include a range of pathogens. Even with vaccines on the horizon in the coming months, the London-based company expects brisk demand for its product.
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Coronavirus and syringes

Moderna seeks EUA for COVID-19 vaccine, reports 100% efficacy against severe disease

Dec. 1, 2020
By Michael Fitzhugh
Moderna Inc., late on Nov. 30, said it has asked the FDA to bless emergency use of its COVID-19 vaccine mRNA-1273 after phase III data confirmed it to be 94.1% effective in preventing symptomatic cases of the disease and 100% effective in preventing severe cases. The Cambridge, Mass.-based company said efficacy was "consistent across age, race and ethnicity and gender demographics."
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COVID-19 vaccine vials

Moderna and Covaxx prep COVID-19 vaccine distribution

Dec. 1, 2020
By Lee Landenberger
Moderna Inc. and Covaxx Inc. are readying for delivery more than 220 million doses of their respective COVID-19 vaccines to Europe and emerging countries in newly cut deals. Moderna, of Cambridge, Mass., said it granted an option to the European Commission to buy up to 80 million additional doses of mRNA-1273 and is set to manufacture 500 million to 1 billion doses globally in 2021. The company said the vaccine, if approved, will ship to the EU beginning in December. The company’s shares (NASDAQ:MRNA) had a solid day Nov. 25, with shares closing 10.78% upward at $109.18.
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