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The Royal Courts of Justice, in London.

Its not just U.K. Prime Minister Theresa May who is bristling at the European Union Court of Justice. Germanys top judges, of all people, have been threatening to sidestep some of its rulings.

The Federal Constitutional Court,the countrys highest tribunal,said in a ruling published last week that it has a duty to ignore the ECJ in Luxembourg in some situations. In a case involving the European Central Bank, the German judges said they must deviate from ECJ decisions when the EU top court fails to stop agencies in the bloc that "blatantly" misread their powers.

The judgment is the latest in a string of cases brought by fierce opponents of EU integration who attacked the Maastricht Treaty, euro rescue programs and the Greek bailouts. While the Constitutional Court always rejected the suits,the judgmentseffectively questioned the ECJs role amid perceived EU shortcomings, including a lack of democratic checks and balances, a theme that should be familiar to Brexiteers.

The German and the British complaints may differ, but the sentiments have similar roots, said Christian Pestalozza, a professor emeritus at Berlins Free University. The ECJ is often perceived as interfering in national affairs.

"Sovereign nations really dont like that very much, and to a certain extent that is understandable," he said. "But in a system like the EU theres no way around it. You have to swallow the bitter pill."

While Germany has always been a staunch supporter of the EU, about a dozen Constitutional Court rulings on the countrys role in the bloc have exposed a spat between the German and EU top courts. Many of the most recent cases involved the euro rescue and the ECBs bond-buyer program -- highly unpopular among Germans who fear they will have to pay the bill. The judgments reflect an uneasiness about the EU among the public at large, saidJoachim Wieland, a law professor at the University of Administrative Sciences.

"Back in the 1980s, the Constitutional Court was very EU-friendly. But the more doubts the Germans developed about the EU, the more critical the court became," said Wieland. Judges are also citizens, they do join these discussions and that influences their view of the law."

The German court has said it would act if EU agencies stretch their powers beyond what the treaties authorize, encroaching on member states rights. Its also said it could intervene in if the EU ever usurps Germanys sovereignty over its own budget.

When the ECJ turns a blind eye in "egregious"cases, the German court has reserved -- but never exercised -- the right to deviate from a Luxembourg ruling.

The issue came to a head when a 2015 judgment on a ECB bond-buying program didnt attach all the strings the German court had called for. In last weeks case, the German justices sent a request to Luxembourg for limits on the ECBsquantitative-easing policy, arguing that without them, it may turn to the weapon of last resort. U.K. citizens turned their unease into a vote to leave the EU altogether -- and the role of the ECJ was a major part of that discussion. In a position paper published Wednesday, however, the U.K. retreated from rhetoric about ending the courts jurisdiction over Britain. It now suggests it will be open to monitoring EU case law, abiding by past ECJ rulings and taking future decisions into account.

Despite the common concerns about the ECJ, Germans say they dont quite understand the British complaints. Peter Bert, a lawyer at Taylor Wessing in Frankfurt, attributes them to confusion between the Luxembourg judges and the Strasbourg, France-based European Court of Human Rights, a non EU-panel that has frequently blocked British efforts to deport suspected terrorists.

The situation is very different "from the viewpoint of some German conservatives who loath the EU top court because of its position on EU integration, especially on the euro rescue issue and the policy of the ECB," said Bert, whose law firm was formed by the merger of English and German law firms. "The Brits arent in the euro zone, so its hard to understand where the dislike comes from."

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German Judges May Share UK's Unease With European Union Court - Bloomberg

The French President is hoping to introduce swathes of European Union reform as he hopes to combat the eurosceptic feelings across his country having defeated leading anti-EU candidate Marine Le Pen.

Adam Plowright, who is releasing Mr Macrons biography in September, said the President hopes to introduce policy to make French people feel like they will not fall victim of the blocs plans for globalisation.

Speaking to Al Jazeera, Mr Plowright said: He was elected in May, promising to completely reform the European Union.

Part of that agenda is making a Europe that is more protective, that makes French people feel like Europe helps them, shields them from globalisation.

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Emmanuel Macron was elected in May, promising to completely reform the European Union

Adam Plowright

Mr Macron has been working hard to earn the support of eastern European states for his reforms to freedom of movement and labour across the Continent.

The French President ruffled feathers across the bloc by questioning its posted workers policy which allows European companies to send employees to work in another EU member country while continuing to pay benefits and taxes in their own country.

High-wage countries such as France argue this amounts to social dumping by allowing companies with lower costs to compete unfairly with local firms.

Many central and eastern European states see the planned changes as nothing more than veiled protectionism and are vehemently opposed.

Emmanuel Macron said: The single European market and the free movement of workers is not meant to create a race to the bottom in terms of social regulations.

I think that Europe should protect [its citizens], and in that way, the European integration project should get a new meaning. Ultimately our citizens want to free themselves from the pressures of globalisation.

A Europe that protects is also in the position to solve the problem of posted workers. The posted workers directive, as it currently works, is a betrayal of the European spirit This only fuels populism in our countries.

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French President Emmanuel Macron poses with his wife Brigitte Trogneux at the Elysee presidential Palace

Estonia, which holds the EU's rotating presidency, is due to table a new proposal in September.

The French president enlisted the Czech and Slovak leaders, meaning he now has half of the four-nation Visegrad group which has opposed western European countries on issues including migrants and reform of the posted workers' directive.

Robert Fico, the Slovak prime minister, said progress had been made and reaching a deal by a meeting of European leaders in October was realistic

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Emmanuel Macron wants to replicate Merkel and RULE the European Union, says biographer - Express.co.uk

European Union Flag

The European Union is estimating a 9.343 million metric ton apple harvest for the 2017-18 growing season, down 21 percent from 2016, according to a press release from Interpoma. The total is equivalent to about 10.3 million U.S. tons, or 1.03 billion 20-pound boxes.

The figures were announced at Prognosfruit, the World Apple and Pear Association annual conference in Lleida, Spain.

Germany should see a decline of about 46 percent, while Poland is forecast to be off by 29 percent and Italy down 23 percent. France predicts an 8 percent decline, while Belgium and the Netherlands will likely see large percentage drops, albeit in relatively small harvests.

Hungary forecasts a 26 percent increase in production to 628,000 metric tons, while Portugal and Spain should see moderate increases.

Switzerland, which is not a member of the EU, is predicting a 21 percent production decrease.

The report also shows that most of the Northern Hemisphere will see smaller apple harvests, with Russia falling 37 percent, followed by Mexico (30 percent), Belarus (19 percent), Ukraine (10 percent) and Canada (6 percent).

The United States will be fairly stable at 4.8 million metric tons (5.29 million U.S. tons), while Chinese production estimated to increase by 3 percent.

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European Union predicts down year for apples - Good Fruit Grower

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

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