Archive for the ‘European Union’ Category

Purigen Biosystems Adds CE Mark for Ionic Purification System Launch in UK and European Union – Business Wire

PLEASANTON, Calif.--(BUSINESS WIRE)--Purigen Biosystems, Inc., a leading provider of next-generation technologies for extracting and purifying nucleic acids from biological samples, today announced the CE (Conformit Europene) marking of its Ionic Purification System. Purigen has certified that its products comply with the European Unions performance, safety, and relevant product and service standards requirements. With the marking, Purigen is now able to support clinical and oncology researchers across the European Union and other CE Mark geographies, including the UK. Purigen is also expanding its commercial operations to help meet the growing worldwide demand for its best-in-class nucleic acid purification technology.

Launched in the US market in 2019, the small benchtop Ionic Purification System enables the automated extraction of nucleic acids with dramatically increased yield and quality from a wide range of sample types, including cultured or sorted cells and formalin-fixed, paraffin-embedded (FFPE) tissues. Biological samples are gently lysed and then loaded into the Ionic Fluidics Chip. The system then applies an electrical field to the chip and the nucleic acids are isolated in their natural, native form using the companys core isotachophoresis (ITP) technology. Since the nucleic acids are not bound or stripped from fixed surfaces, nucleic acid loss and fragmentation are minimized while purification-induced bias is eliminated. The simplified workflow requires minimal hands-on time and produces higher yields of high-quality RNA and DNA that are truly representative of the starting sample.

Scientists at the Centre for Environment Fisheries and Aquaculture Science (CEFAS) in the UK will be using the Ionic Purification System in non-clinical research applications to study diseases of commercially cultured and harvested fish and shellfish, along with microbial risks to human health from shellfish and other aquatic sources. The team is purifying RNA and DNA from FFPE tissue samples collected from animals, seaweeds, bacteria, and other aquatic samples prior to qPCR and NGS analysis.

Our work at CEFAS provides policy and scientific advice globally to enhance food security and to protect public health, said David Bass, PhD, Principal Investigator at CEFAS. Our FFPE samples are limited and the Purigen technology provides us with more nucleic acid for our genomic assays via a very simple workflow. This will be particularly valuable for our roles leading the OIE Collaborative Centre for Emerging Aquatic Animal Diseases, and FAO Reference Centres for Antimicrobial Resistance and Bivalve Mollusc Sanitation.

Over the past year, we have seen increasing interest in our innovative Ionic Purification System from around the world, especially in the UK and European Union, said Barney Saunders, PhD, CEO of Purigen Biosystems. Im proud that our team was able to quickly shift priorities to secure the appropriate regulatory approvals, which has enabled us to expand our commercial operations. Today, we are now able to empower more clinical researchers in Europe with the ability to maximize the utility of their precious samples.

Ionic Purification System Components

The complete Ionic Purification system includes the following components:

About Purigen Biosystems

Purigen Biosystems is redefining nucleic acid sample preparation with an innovative platform based on the highly efficient isotachophoresis technology invented by Juan Santiago, PhD, and his team at Stanford University. Purigens automated benchtop instrumentation and accompanying microfluidic chip purify nucleic acid samples from a wide variety of sources, including minute or otherwise challenging cancer samples. The purified nucleic acids are then immediately compatible with a wide range of downstream detection methods, including next-generation sequencing, PCR, and other genomic tests. For more information, visit http://www.purigenbio.com.

Ionic is a registered trademark of Purigen Biosystems, Inc. All other trademarks are the property of their respective owners. All products described herein are intended FOR RESEARCH USE ONLY and NOT FOR USE IN DIAGNOSTIC PROCEDURES.

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Purigen Biosystems Adds CE Mark for Ionic Purification System Launch in UK and European Union - Business Wire

The European Union is Planning to Open Borders to Vaccinated Tourists in June 2021 – Tatler Singapore

After closing their borders for over a year due to the Covid-19 pandemic, the European Union (EU) could finally be opening their borders to fully vaccinated tourists in June this year, which is in time for the summer holidays. The tourists allowed in would be from countries with low Covid-19 infection rates.

In the plan, which was revealed on Monday by the EU, officials announced that the move came just as most members of the 27-nation bloc were planning to move ahead with the opening.

(Related: Covid-19 Vaccine: These Countries are Now Welcoming Vaccinated Travellers)

In fact, Greece, in an announcement made last month, had already said that all fully vaccinated or tested travellers could enter their country from mid-May onwards.

Under the current restrictions, only travellers from seven countries are allowed to enter the EU for non-essential travel regardless of whether they have been vaccinated or not. These countries include Singapore and Australia and still require travellers to be tested and quarantined.

With the new proposals, the EU would require travellers to be fully vaccinated against Covid-19 and to have a "good epidemiological situation" before they would be allowed in.

The EU also suggested that an emergency break should be introduced to limit the risk of importing new cases or variants of the virus. This means that travel restrictions would be able to come into place quickly should a country experience a deterioration in its Covid-19 situations.

EU member states will be discussing this proposal this week.

(Related: Singapore, Malaysia to Allow Cross-Border Travel on Compassionate Grounds From May 17)

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The European Union is Planning to Open Borders to Vaccinated Tourists in June 2021 - Tatler Singapore

European Union Mulls Easing Travel Restrictions on Fully Vaccinated Tourists from Next Month – News18

Europe is looking at easing travel restrictions on foreign tourists as early as next month, if they are fully vaccinated or come from a country with Covid under control, officials said Monday.

The European Commission is recommending EU member states agree to restart the blocs vital tourist industry in time for the European summer after a wipe-out season last year when travel plummeted worldwide.

Time to revive the EU tourism industry and for cross-border friendships to rekindle safely," commission chief Ursula von der Leyen tweeted.

But there are caveats. Brussels is seeking to ensure the EUs rapidly accelerating vaccination rollout is not threatened by new virus variants, and that there is reciprocity for Europeans going abroad.

The commission statement said vaccinated people arriving in the EU on non-essential travel" would need to have received EU-approved jabs, currently those from BioNTech/Pfizer, Moderna, AstraZeneca and Johnson & Johnson.

Even if they are fully immunised meaning having received two doses, except for the single-jab Johnson & Johnson vaccine, then waiting two weeks for them to be fully effective EU countries can still require Covid tests, quarantine or even both.

Then there is an emergency brake" allowing EU countries to halt arrivals from where a variant of concern or interest is detected", such as those spreading in Brazil, India and South Africa.

Even vaccinated persons would be subject to the travel restrictions coming from these countries subject to this emergency brake," said a commission spokesman, Adalbert Jahnz.

In terms of how the EU would judge whether other countries are doing a good enough job in curbing Covid, the key metric would be their infection rate per 100,000 inhabitants averaged over two weeks.

An EU official involved in drafting the recommendation told journalists an old threshold of 25 infections per 100,000 fixed nearly a year ago would be raised to 100 to reflect a different reality" because of increasing vaccinations.

Consequently, the EUs list of acceptable countries could expand from seven at the moment Australia, New Zealand, Rwanda, Singapore, South Korea and Thailand; and China with a thus-far-unmet reciprocity condition to many more.

Last week, von der Leyen told the New York Times she expected many Americans to be able to return to the EU as tourists for summer, given the US vaccination programme.

European countries are keen to welcome back big-spending American tourists under the eased travel restrictions, though the EU official speaking to journalists said the US must first put its own house in order".

He said he hoped to see a gradual convergence" of vaccine certificate registration in the US to overcome the current fragmented situation of US states issuing many different certificates, making verification difficult internationally.

The International Tourism Organisation and the World Health Organization (WHO) were working on certification that would be accepted globally, he noted.

Closer to Europe, there is a question mark" about how former EU member Britain, which has strained relations with Brussels post-Brexit, might benefit from the blocs easing of rules.

The EU official acknowledged that the figures for the UK are good", with a vaccination rollout that got a head start on the EUs and a relatively low infection rate.

But, he stressed, there is the issue of reciprocity", which will have to be mulled over collectively by the EU member states.

Britain currently requires arrivals from countries other than EU member Ireland, with which it shares a common travel arrangement, to quarantine.

The British government this week is to give a list of countries it deems acceptable for travel to without quarantine, but is expected to keep many EU countries on its quarantine list.

While the European Commission recommendation talks about vaccines approved by the European Medicines Agency, it says other Covid-19 vaccines accepted by the WHO for emergency-use jabs may be added later.

As it stands, though, neither Russias Sputnik V vaccine nor ones made by China would be included, excluding jabs that are used in dozens of lower-income countries.

That goes in the same direction of the EUs planned digital green certificate" which is also to be launched next month for Europeans to be able to travel more freely within the bloc.

That document will not only show the vaccination status of the bearer, but also recent negative Covid test results, and immunity acquired while recovering from a Covid infection.

Read all the Latest News, Breaking News and Coronavirus News here

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European Union Mulls Easing Travel Restrictions on Fully Vaccinated Tourists from Next Month - News18

Pfizer asks European Union to approve vaccine for kids aged 12 to 15 – Global News

ByStaffThe Associated Press

Posted April 30, 2021 7:27 am

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Pfizer and BioNTech have submitted a request for European Union drug regulators to extend the approval of the companies coronavirus vaccine to include children ages 12 to 15, a move that could offer younger and less at-risk populations in Europe access to the shots for the first time.

In a statement on Friday, the two companies said their submission to the European Medicines Agency was based on an advanced study in more than 2,000 adolescents that showed the vaccine to be safe and effective. The children will continue to be monitored for longer-term protection and safety for another two years.

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BioNTech and Pfizer previously had requested their emergency use authorization with the U.S. Food and Drug Administration also be extended to children 12-15.

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The COVID-19 vaccine made by Pfizer and BioNTech was the first one to be granted a greenlight by the EMA in December, when it was licensed for anyone age 16 and over across the 27-nation EU.

2021 The Canadian Press

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Pfizer asks European Union to approve vaccine for kids aged 12 to 15 - Global News

Tampere, the ”Sauna Capital” of the world, applies to become the European Capital of Culture – Business Wire

TAMPERE, Finland--(BUSINESS WIRE)--Tampere is famous for having more public saunas than any other city in Finland. Now Tampere, the self-declared sauna capital of the world wants to be also the European Capital of Culture in 2026.

Finns say that in a sauna everyone is equal. Tampere26 project has chosen Equality as the main theme of its Culture of Capital year.

Tampere26s application is built around the values of equality, diversity, accessibility and sustainability. The aim is to increase equality through culture, discuss social and environmental issues, increase diversity and togetherness and work on a common European identity.

Equality has been a fundamental right for citizens of the European Union since its foundation. Tampere26 slogan Equally European is a long-term development project where we invite Europeans to take care of equality, a value that is under threat. We still have a lot to learn on this matter, says Tampere26 Project Director Perttu Pes.

Finland has a great history regarding equality. It was the first country to grant women full political rights in 1906 and Tampere played a significant role in this process. In 1905 a total of 40,000 people gathered in the central square of Tampere to demand general suffrage.

The cultural program of Tampere26 promises cultural enriching happenings, from massive shows to small-scale events like village fetes in the rural areas of the Tampere Region. 19 municipalities of the region are participating in this project with Tampere.

Moomin on Ice ballet takes place in the brand new Uros Live Arena, a venue for over 13,000 spectators. On the other hand, some activities will happen in the national parks far away from the city.

Tampere26 celebrates the opening of Tampere Art Museums extension and at the same time dedicates part of the program to the vibrant skateboarding culture. Of course, sauna is included. The program is compiled from over 1000 proposals, and it was developed in cooperation with 150 international partners.

Tampere26s operating budget for the seven-year period (2021-2027) is 53.18 M. The final selection will be made by a panel of European experts on the 2nd of June 2021. They choose between Tampere, Oulu, and Savonlinna.

More information at website: https://tampere26.fi/

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Tampere, the ''Sauna Capital'' of the world, applies to become the European Capital of Culture - Business Wire