Archive for the ‘European Union’ Category

Has ‘ambitious’ British PM aimed too high with EU demands? – Reuters

LONDON (Reuters) - Prime Minister Theresa May always said she would be "ambitious" in negotiating Britain's exit from the European Union, and government documents published this month show the scale of that ambition -- wanting the closest of ties without the costs.

But the new British proposals for future ties with the EU have been dismissed in Brussels as "fantasy" and no more than an "intra-UK debate". European officials have suggested that Britain should instead stick to a previously agreed timetable for Brexit negotiations.

For Britain, the release over two weeks of a series of strategy and discussion documents was intended to counter criticism that it was unprepared for the talks, and to speed up negotiations that have moved slowly over the past 14 months.

It was also a chance for May to rally her troops and show she is still on course for Brexit after her authority was weakened when she lost her parliamentary majority in an election in June, a party source said.

"I want us to be a truly Global Britain the best friend and neighbor to our European partners, but a country that reaches beyond the borders of Europe too," May said in March after triggering the divorce process with the EU.

"And that is why I have set out a clear and ambitious plan for the negotiations ahead. It is a plan for a new deep and special partnership between Britain and the European Union."

This refrain has provided the background to the three "position papers" released since last week, setting out Britain's view that such a "deep and special partnership" requires little change.

But perhaps more surprising was the strategy set out in the future relationship papers, especially those on customs and the role of the European Court of Justice -- the latter seen by many pro-Brexit lawmakers in the Conservative Party and beyond as a symbol of EU influence over Britain and of the country's lack of sovereignty.

Guy Verhofstadt, the European Parliament's Brexit point-man, described the British government's ideas for a future customs agreement as "fantasy" after it outlined measures for an interim deal with no customs duties, intended to allow the freest possible trade in goods, and suggestions for a possible new trade partnership.

"To be in and out of the customs union and 'invisible borders' is a fantasy," he said on Twitter.

"First need to secure citizens rights and a financial settlement," Verhofstadt said, referring to the rights of EU nationals living in Britain and of Britons living in the EU, and to EU demands that Britain settle a hefty Brexit bill.

After pointing to what he saw as lack of clarity on Britain's future relationship with the European Court of Justice, a European Commission spokesman said: "You will not be surprised to hear me refraining from injecting myself into an intra-UK debate on their positions."

He and other EU officials said Brussels' stance was the same: Britain should first focus on making progress on the three main issues in the initial phase of talks - the rights of expatriates, Britain's border with EU member state Ireland, and a financial settlement.

Verhofstadt mocked comments made by Dominic Raab, Britain's minister for courts and justice, that Britain would have to keep "half an eye" on the European court while ensuring that London's Supreme Court was able to live up to its title.

"UKgov wants to keep "half an eye" on ECJ rulings. EP (European Parliament) thinks ECJ must keep both eyes open to protect #citizensrights," he tweeted, referring to the EU position that only its court can guarantee the rights of citizens living in Britain.

Britain says it is being "constructive" by coming up with suggestions on ways to start discussion on future ties. But after publishing seven documents in just over a week, it is clear that Brussels is far from impressed.

Britain has published 10 papers since June 26.

On Monday, after two papers were released, Michel Barnier, the EU's chief negotiator, took to Twitter to list the bloc's nine position papers already published, on issues ranging from citizens rights to the financial settlement.

"Looking forward to discussing these papers with #UK. Essential to make progress on #citizensrights, settling accounts and #Ireland," he said.

The gap in viewpoints in some areas - namely the financial settlement, role of the European court and future trade and customs arrangements - suggests talks next week between Barnier and British Brexit minister David Davis will be difficult and both sides have not set the bar high for progress.

But that may play into some people's hands in a Conservative Party which has long been home to eurosceptics.

"The more people see the EU pouring cold water on British ideas and rubbishing our ideas, the more people will get fed up," a source in the Conservative Party said.

"It's fine for Brits to criticize their own country, but when someone else does, then they go into fighting mode."

Reporting by Elizabeth Piper; editing by Giles Elgood

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Has 'ambitious' British PM aimed too high with EU demands? - Reuters

IMRALDI, Biogen’s Adalimumab Biosimilar Referencing Humira … – Markets Insider

The European Commission (EC) granted a marketing authorization for IMRALDI (also known as SB5), an adalimumab biosimilar referencing Humira.1

IMRALDI has been developed by Samsung Bioepis, a joint venture between Samsung BioLogics and Biogen (NASDAQ, BIIB) and is approved for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, Crohns disease, pediatric Crohns disease, ulcerative colitis and uveitis.

IMRALDI is the third anti-TNF biosimilar from Biogen to receive a marketing authorization in the European Union (EU) following the approval in 2016 of BENEPALI (etanercept), a biosimilar referencing Enbrel,2 and FLIXABI (infliximab), a biosimilar referencing Remicade.3 Anti-TNF therapies represent some of the EUs largest drug expenditures, costing an estimated $9 billion (8 billion) each year from 2011 to 2014.4,5 Introducing biosimilars of the top three anti-TNF therapies in Europe could lead to estimated potential savings of up to $11.44 billion (9.69 billion), between the patent expiry date of each reference product and 2020.5,6 With the approval of IMRALDI, Biogen has become the first company to have approved biosimilars for all three of these therapies.

"Todays decision marks another positive step in transforming the lives of people with chronic autoimmune conditions, said Jean-Paul Kress, EVP International and Head of Global Therapeutic Operations, Biogen. "As the number of approved biosimilars continues to grow, so does the anticipated potential to increase physician choice and patient access to biologics.

The EC approval was based on a robust preclinical and clinical data package comparing IMRALDI with Humira. The clinical data include results from two head-to-head studies a Phase I study in healthy volunteers that demonstrated pharmacokinetic bioequivalence to Humira7 and a 52 week Phase III, randomized, double-blind, multicenter study, in which IMRALDI demonstrated comparable efficacy and comparable safety and immunogenicity to Humira in patients with moderate to severe RA despite methotrexate therapy.8,9 The primary endpoint of the Phase III study, the American College of Rheumatology 20% (ACR20) response at Week 24, was met, demonstrating equivalent efficacy to Humira (ACR20 response rate was 72.5% in the IMRALDI group versus 72.0% in the Humira group).8 Between Week 24 and Week 52, in 125 patients who were switched from Humira to IMRALDI, efficacy, safety, and immunogenicity profiles were found to be comparable to those in patients who remained on Humira (129) or IMRALDI (254) during the transition period.9

About Biogen Through cutting-edge science and medicine, Biogen discovers, develops and delivers innovative therapies worldwide for people living with serious neurological and neurodegenerative diseases. Founded in 1978, Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimers disease, Parkinsons disease and amyotrophic lateral sclerosis. Biogen also manufactures and commercializes biosimilars of advanced biologics. For more information, please visit http://www.biogen.com. Follow us on social media Twitter, LinkedIn, Facebook, YouTube.

Biogen Safe Harbor This press release includes forward-looking statements, including statements about the indications from approval and anticipated access to IMRALDI in the EU, and the potential cost savings from the availability of IMRALDI and other biosimilar anti-TNF therapies in the EU. These forward-looking statements may be accompanied by such words as "anticipate," "believe," "estimate," "expect," "forecast," "intend," "may," "plan," "will," and other words and terms of similar meaning. You should not place undue reliance on these statements. Drug development and commercialization is a lengthy and complex process, which involves a high degree of risk. Factors that could cause actual results to differ materially from our current expectations include: the risk that unexpected concerns may arise from additional data or analysis, or regulatory authorities may require additional data or information or further studies, or may fail to approve, or refuse to approve, or may delay approval of our biosimilar drug candidates; risks related to our dependence on third parties for the development and commercialization of biosimilars; risks of legal actions, regulatory scrutiny or other challenges to biosimilars which could prevent the commercial launch of a product or delay it for many years; and the risks of other unexpected hurdles. For more detailed information on the risks and uncertainties associated with our drug development and commercialization activities, please review the Risk Factors section of our most recent annual or quarterly report filed with the Securities and Exchange Commission. These statements are based on our current beliefs and expectations, and speak only as of the date of this press release. We do not undertake any obligation to publicly update any forward-looking statements.

References

1 Humira is a registered trademark of AbbVie Biotechnology Ltd. 2 Enbrel is a registered trademark of Wyeth LLC. 3 Remicade is a registered trademark of Janssen Biotech, Inc. 4 Extrapolated from global sales from Global Data PMLive Top 50 report, available at: http://www.pmlive.com/top_pharma_list/Top_50_pharmaceutical_products_by_global_sales. Accessed August 2017 5 Currency exchange rates (rounded). Available at: http://www.xe.com. Accessed August 2017. 6 Psachoulia E, et al. Potential impact of the biosimilars introduction of 3 anti-TNFs in the European market. Value Health 2017;20(5);A143. 7 Shin D, et al. A Phase I Pharmacokinetic Study Comparing SB5, An Adalimumab Biosimilar, And Adalimumab Reference Product (Humira) in Healthy Subjects. Ann Rheum Dis 2015;74 (suppl 2):1265. 8 Weinblatt M, et al. A Phase III, Randomized, Double-Blind Clinical Study, Comparing SB5, An Adalimumab Biosimilar, with Adalimumab Reference Product (Humira) in Patients with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy (24-week results) [abstract]. Arthritis Rheumatol 2015;67 (suppl 10). 9 Weinblatt M, et al. FRI0161 Sustained Efficacy and Comparable Safety and Immunogenicity after Transition To SB5 (An Adalimumab Biosimilar) vs Continuation of The Adalimumab Reference Product in Patients with Rheumatoid Arthritis: Result of Phase III Study. Annals of the Rheumatic Diseases 2016;75:487.

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IMRALDI, Biogen's Adalimumab Biosimilar Referencing Humira ... - Markets Insider

Patriots are Europeans! Eurocrat’s shock claim comparing nationalism to alcoholism – Express.co.uk

The first Vice-President of the European Commission made the shocking claim in a video discussing the risks of nationalism.

Mr Timmermans said: "Nationalism is like alcoholism: a short period of exaltation followed by a long period of headaches.

"If nationalism makes us poor, weak and morally insecure, how can it claim to be patriotic?To be a patriot is to be European, to be European is to be a patriot."

GETTY/EU COMMISSION

The footage was released to commemorate the victims of all totalitarian and authoritarian regimes which the EU celebrates annually in August.

He continued: "A true patriot is proud of his nation, wants it to be strong, peaceful, prosperous and values-based.

"To achieve that, a true patriot knows he needs unity, he wants openness, he craves cooperation with others. he sees the strength found in compromise, debate, and unity."

The European Union is currently facing growing dissent from member states.

Euroscepticism has spread throughout the union, with parties starting to question the functionality of the European Union.

In France, presidential candidate Marine Le Pen gained 33.9% of the popular vote running on a deeply anti-EU platform.

Italian Five Star Movement (M5S) is currently polling at 27.6% against ruling Democratic Party (PD)'s 26.9% ahead of the 2018 general elections.

The party has been very vocal in its critic of the European Union, especially in regards to matters concerning the Euro and the migrant crisis.

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Patriots are Europeans! Eurocrat's shock claim comparing nationalism to alcoholism - Express.co.uk

Casino campaign hires firm behind European Union exit effort – News & Observer

Casino campaign hires firm behind European Union exit effort
News & Observer
A campaign to persuade voters to approve a southern Maine casino has reported getting assistance from a firm that helped persuade British voters to withdraw from the European Union. Progress for Maine PAC has reported paying more than $80,000 to ...

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Casino campaign hires firm behind European Union exit effort - News & Observer

Eritrea gets new European Union head of delegation – africanews


africanews
Eritrea gets new European Union head of delegation
africanews
As head of the EU delegation, Carbo will also be the ambassador of the continental bloc in the Horn of Africa country. His previous appointment was in Benin where he held the same position. The EU foreign affairs chief, Federica Mogherini, in a ...

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Eritrea gets new European Union head of delegation - africanews