Archive for August, 2017

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

On Afghanistan, There’s No Way Out – New York Times

Weve tried killing terrorists. Lots and lots of them. As many as 42,000 Taliban and other insurgents have been killed and another 19,000 wounded in fighting since 2001, according to one rough 2016 estimate. The United States has also carried out more than 400 drone strikes in Pakistan, decimating Al Qaedas core leadership. Last year a drone took out the Taliban leader Mullah Akhtar Muhammad Mansour.

Result: The Talibans numbers in 2005 were estimated at anywhere between 2,000 and 10,000 fighters. Within a decade, those numbers had grown to an estimated 60,000 fighters.

Weve tried carrots and sticks with Pakistan. In 2011, Washington gave $3.5 billion in aid to Islamabad. That same year we killed Osama bin Laden in the garrison city of Abbottabad. Then the aid plunged.

Result: Last month, James Mattis withheld another $50 million in aid because the Defense Department could not certify that Pakistan had taken sufficient action against the Haqqani network, though Islamabad claims otherwise. American leverage with Pakistan has declined as Chinese investment in the country has surged, reaching $62 billion this year.

Weve tried diplomacy. Getting the Taliban to the table was one of John Kerrys core ambitions as secretary of state. Afghan President Ashraf Ghani and his predecessor, Hamid Karzai, both made clear they were eager to reach an accommodation.

Result: The Taliban launched a rocket attack aimed at Kerry during his visit to the country last year. The groups insistence that all foreign troops withdraw before it enters talks gives away its game, which isnt to share power with the elected government, but to seize power from it.

What about two supposedly untried options: another surge, exceeding what Obama did in troop numbers but not limited by deadlines or restrictive rules of engagement; or, alternatively, a complete withdrawal of our troops?

But thats been tried, too. Soviet forces in Afghanistan in the 1980s practiced a bomb-the-stuff-out-of-them approach to warfare, likely including the use of chemical weapons. They devoted a decade to the effort and lost. America effectively abandoned the region, too, as we imagined life in a supposedly post-historical world.

We know what happened next. Between 1990 and 2000, tens of thousands of Afghans as many as a million people, according to one estimate died in three waves of civil war. The Taliban took Kabul in 1996; Osama bin Laden returned that same year. Pakistan and India tested nuclear weapons two years later. Then came Sept. 11, 2001.

President Trump may think hes trying something new with his Afghan policy. He isnt. Obama killed a lot of terrorists. George W. Bush pursued what amounted to a conditions-based approach, without target dates for withdrawal. Both were often stern with Pakistan. Both conducted intensive policy reviews.

Trump may also think hes going to win in Afghanistan. Thats not happening either, not in our lifetimes. Even if we could kill every insurgent tomorrow, they would return, as long as they can draw on the religious fanaticism of the madrasas, the ethnic ambitions of the Pashtun, and the profits of the heroin trade.

A more forthright president might have leveled with the American people. We wont win, at least as most of us imagine winning. But we cant leave, not least because it would create the kind of vacuum in Afghanistan that the Islamic State so swiftly filled, to such devastating local and international effect, in Syria and Iraq.

What can we do? With relatively modest troop increases, we can provide the elected Afghan government with sufficient military support to reverse some of the Talibans recent gains and ensure that it cannot seize Afghan cities or control entire provinces. With relatively modest troop numbers, we can also try to keep U.S. casualties relatively low over time, avoiding the political race to the exits when combat fatalities rise.

Bottom line: We need an approach thats Afghan-sufficient, from a military point of view, and America-sustainable, from a political one, for the sake of an open-ended commitment to an ill-starred country from which there is no way out.

Trump, incredibly, may have alighted on the best of a bad set of Afghan options.

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On Afghanistan, There's No Way Out - New York Times

Afghanistan: New Zealand boosts army commitment, by three – The Guardian

Trump had signed off on plans to send about 4,000 more troops and asked allies to do the same. Photograph: David Furst/AFP/Getty Images

Just days after the United States said it would increase troop numbers in Afghanistan and ask its allies to do the same, New Zealand has announced an extra three non-combat military personnel, boosting its military commitment to 13.

Donald Trump on Monday unveiled his strategy to end the conflict in Afghanistan, committing the United States to an open-ended conflict and signalling he would dispatch more troops to Americas longest war.

US officials have said the president signed off on plans to send about 4,000 more troops to add to the roughly 8,400 now deployed in Afghanistan. The US defence secretary, James Mattis, has since said that exact troop numbers are yet to be decided.

Trump said he would ask coalition allies to support his new strategy, with additional troops and funding, to end the 16-year conflict.

New Zealand defence minister Mark Mitchells announcement boosting the countrys Kabul-based troops to 13 follows a request for Nato to send more troops to Afghanistan earlier this year.

New Zealand has had troops in Afghanistan since 2001. Its presence has been decreasing since 2013 but it has kept some personnel on the ground to train local officers.

New Zealand will continue to stand alongside our partners in supporting stability in Afghanistan and countering the threat of international terrorism, said Mitchell.

The New Zealand prime minister, Bill English, said the government had ruled out making a decision on sending combat troops to Afghanistan before New Zealands election on 23 September.

The opposition leader, Jacinda Ardern, told local media this week she would not back sending troops to Afghanistan at the moment but was not privy to intelligence such decisions were based on.

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Afghanistan: New Zealand boosts army commitment, by three - The Guardian

A ‘win’ in Afghanistan includes peace talks with the Taliban, say U.S. … – Washington Post

KABUL The two top U.S. diplomatic and military officials here sought Thursday to allay confusion and concern among Afghans about President Trumpsstrategy for Afghanistan, stressing American support for possible peace talks with Taliban insurgents alongside a new, open-ended military commitment.

Gen. John W. Nicholson Jr., commander of U.S. forces in Afghanistan, and the senior U.S. Embassy official, special charge daffaires Hugo Llorens, spoke at a joint news conference about the importance of reaching a settlement with the Taliban in an attempt to end the nearly 16-year war.

In an address Monday, Trump focused on winning the war and depicted an accord as a remote possibility.Both U.S. officials were careful to avoid contradicting the president, framing their comments as additional details and reinforcement of his message.

We are determined to pursue the goal of a political settlement. As these terrorist groups realize that they cannot win, they will see that their best option is to pursue peace, Nicholson said. He invited the Taliban to lay down your arms and join Afghan society. Help build a better future for this country and your own children.

Although Afghan officials embraced Trumps message, many Afghan commentatorsexpressed concern this week that it focused too narrowly on fighting the Taliban and terrorists. Former Afghan president Hamid Karzai called it a formula based on killing, killing, killing.

[In Afghanistan, Trumps speech brings relief to some. To others, it means more war, destruction.]

Afghans also voiced worries about Trumps declaration that the U.S. government would no longer pursue nation building in Afghanistan and elsewhere. The United States has invested billions of dollars since 2001 in efforts to rebuild Afghanistan, yet the country is still struggling with political divisions and a moribund economy.

Nicholson and Llorens following similar reassurances made by Secretary of State Rex Tillerson in Washington after Trumps speech emphasized that the new policy would be much more than a battle plan. Llorens said it would integrate all the instruments of American power, including diplomacy and economic support.

But Nicholson also emphasized the U.S. military commitment to the war effort, vowing to pursue and annihilate Islamic State forces in Afghanistan and to prevent Afghanistan from becoming a haven for international terrorists.

Like Trump, the general declined to say how many additional U.S. troops would be sent. But he rejected criticism that the new military strategy would echo previous U.S. policies that did not make significant headway, even with more than 100,000 foreign troops in Afghanistan at one time.

[Thousands more troops are probably headed to Afghanistan. Heres what theyll do.]

One difference Nicholson cited was the current Afghan government, which he called a trusted partner that seeks to reform and professionalize the security forces. He also praised the Afghan special operations forces, which will be doubled in size and trained by U.S. and NATO advisers.

These brave soldiers have never lost a battle, Nicholson said. With the additional support we will provide them, they will become larger and more lethal.

Nicholson expressed concern about the high level of Afghan war casualties, saying, The United States deeply appreciates and respects the sacrifice and strength of the Afghan people. Rising casualty rates have become a source of growing concern here, with more than 11,000 Afghan civilians killed or injured last year.

Nicholson also touted the shift from an American strategy of support based on arbitrary timelines to one guided by conditions on the ground.You can believe it will be different, because we removed the calendar from the equation, he said.

Read more:

The Taliban is sowing terror in remote, new areas of Afghanistan

How Afghanistan is ramping up its fight against corruption especially among the countrys elite

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A 'win' in Afghanistan includes peace talks with the Taliban, say U.S. ... - Washington Post