Archive for the ‘European Union’ Category

EU Approves Olaparib in Combination with Bevacizumab to Treat Advanced Ovarian Cancer – Cancer Network

Olaparib (Lynparza) in combination with bevacizumab (Avastin) has been approved in the European Union as a first-line maintenance treatment for adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer, according to a press release from AstraZeneca and Merck.

The patients included are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab whose cancer is associated with homologous recombination deficiency (HRD)-positive status.

Half of all newly diagnosed patients with advanced ovarian cancer have HRD-positive tumors, Dave Fredrickson, executive vice president of AstraZeneca, said in a press release. Women treated with Lynparza in combination with bevacizumab in the PAOLA-1 Phase 3 trial lived progression free for a median of more than three years, showing that HRD testing should be an essential component of clinical diagnosis. HRD status can help physicians select a personalized first-line treatment regimen for patients to substantially delay relapse in this devastating disease.

The combinations approval was based on data from a biomarker subgroup analysis of the PAOLA-1 phase 3 trial. The data showed that the combination of olaparib with bevacizumab demonstrated a progression-free survival (PFS) benefit compared to bevacizumab alone for patients with HRD-positive advanced ovarian cancer.

The trials data, published in The New England Journal of Medicine, revealed that the combination maintenance treatment reduced the risk of disease progression or death by 67% (HR, 0.33; 95% CI, 0.25-0.45), while the addition of olaparib to bevacizumab improved PFS to a median of 37.2 months compared to 17.7 months for bevacizumab alone.

Adverse events (AEs) occurring in more than 10% of patients in PAOLA-1s population treated with olaparib combined with bevacizumab included fatigue (53%), nausea (53%), anemia (41%), lymphopenia (24%), vomiting (22%), and leukopenia (18%). More, grade 3 or higher AEs included anemia (17%), lymphopenia (7%), fatigue (5%), nausea (2%), leukopenia (2%), and vomiting (2%).

The research also found that serious AEs occurred in 31% of patients receiving the olaparib combination, while fatal AEs occurred in 1 patient due to concurrent pneumonia and aplastic anemia.

Biomarker testing has rapidly enhanced our understanding of how PARP inhibition can help target this devastating disease, Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer of Merck Research Laboratories, said in a press release. The EU approval reinforces that HRD-positive tumors represent a distinct subset of advanced ovarian cancer and HRD testing is critical for women in this setting.

Reference:

LYNPARZA (olaparib) in Combination with Bevacizumab Approved in the EU as First-Line Maintenance Treatment for HRD-Positive Advanced Ovarian Cancer [news release]. Kenilworth, New Jersey. Published November 5, 2020. http://www.digitaljournal.com/pr/4867462. Accessed November 6, 2020.

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EU Approves Olaparib in Combination with Bevacizumab to Treat Advanced Ovarian Cancer - Cancer Network

What will President Biden’s United States look like to the rest of the world? – The Guardian

What is the best the world can now hope for from the United States under President Joe Biden, now that the election has been called for him? My answer: that the US will be a leading country in a post-hegemonic network of democracies.

Yes, thats a, not the leading country. Quite a contrast to the beginning of this century, when the hyperpower US seemed to bestride the globe like a colossus. The downsizing has two causes: the USs decline, and others rise. Even if Biden had won a landslide victory and the Democrats controlled the Senate, the United States power in the world would be much diminished. President Donald Trump has done untold damage to its international reputation. His disastrous record on handling Covid confirmed a widespread sense of a society with deep structural problems, from healthcare, race and infrastructure to media-fuelled hyper-polarisation and a dysfunctional political system.

In a recent eupinions survey, more than half of those asked across the European Union found democracy in the US to be ineffective. And that was before Trump denounced as fraud the process of simply counting all the votes cast in an election. When the US lectures other countries on democracy these days, the politest likely answer is: Physician, heal thyself!. Even compared with the grim period of Vietnam and Watergate, this must be an all-time low for American soft power.

Europe has many problems of its own, but set against the record of US regress over the last 20 years, our European story looks like triumphal progress. The same can be said for Australia, New Zealand or Canada. Still more dramatic has been Chinas rise, facilitated by years of American strategic distraction.

Even assuming that all legal challenges to his election will have been dealt with when the 46th president is inaugurated next January, he will face an almost bitterly divided country, an almost certainly divided government and a far from united Democratic party. Thanks to Trumps shameless mendacity, millions of Trump voters may not accept even the basic legitimacy of a Biden presidency. His ability to push through desperately needed structural reforms will be hampered, if not stymied, if the Republicans retain control of the Senate.

Fortunately for the rest of us, the area in which he will have most freedom of manoeuvre is foreign policy. Biden has immense personal foreign policy experience, as a former vice-president and before that, chair of the Senate foreign relations committee. He has an experienced foreign policy team. Members of that team identify their greatest strategic challenges as the 3 Cs: Covid (including its global economic aftermath), climate change and China. Thats an agenda on which allies in Europe and Asia can happily engage. Rejoining the Paris climate agreement, which the US formally left on Wednesday, will be an important first step.

Nato remains essential for Europes security against an aggressive Russia, but the key to winning back disillusioned Europeans will be to offer a new quality of partnership to the European Union. Even before he becomes president, Biden might like to express his appreciation for the way the EU has kept the flag of liberal internationalism flying while the US under Trump was awol. His first presidential visit to the old continent should include the EU institutions in Brussels. (Perhaps an address to the European parliament?) A bipartisan reference back to President George HW Bushs 1989 partners in leadership speech in Germany could be helpful, but applying it now to the entire EU. In this partnership of equals, the US will not always sit at the head of the table. Thats what I mean by post-hegemonic.

Europeans should do more for their own security, but Biden would be unwise to start by hammering away at the old Spend 2% of your GDP on defence theme. The German strategic thinker Wolfgang Ischinger has suggested a good way to reframe the issue: think of it rather as 3% on 3D that is, defence, diplomacy and development. A self-styled geopolitical EU must assume a greater burden in its wider neighbourhood, which means to the south, across the Mediterranean to the Middle East and north Africa, and to the east, in relations with Belarus (currently in peaceful revolt), Ukraine and Vladimir Putins aggressive but also fundamentally weak Russia.

A new emphasis on the EU will leave the ultra-Brexiters who dominate Boris Johnsons government in Britain feeling slightly miffed. But the Johnson government does have one good idea, which is to extend the G7 meeting it will host next year to major democracies in Asia.

This chimes perfectly with a central leitmotif of the Biden team: working with other democracies. The US already has the Quad format, linking it with Australia, Japan and India. They will be at least as important as the EU and Britain when it comes to dealing with China.

If the Biden administration is wise, it will envisage this as a network of democracies, rather than a fixed alliance or community of democracies. Even a summit of democracies, reportedly a pet scheme of the president elect, would pose tricky questions of whos in and whos out. Think of it as a network, however, and you can keep it flexible, varying the coalitions of the willing from issue to issue and finessing the difficult borderline cases. For example, Narendra Modis India is anything but a model liberal democracy at the moment, yet indispensable for addressing the 3 Cs.

On every issue, both the US and Europe should start by identifying the relevant democracies; but of course you cant stop there. You have also to work with illiberal and anti-democratic regimes, including China. China is the greatest geopolitical challenge of our time. It is itself one of the 3 Cs, yet also crucial for addressing the other two: climate change and Covid. It is a more formidable ideological and strategic competitor than the Soviet Union was, at least from the 1970s onward, but its cooperation is also more essential in larger areas.

In pursuing a twin-track strategy of competition and cooperation, the US has unique strengths. Although the greatest military the world has ever seen ended up losing a war against technologically inferior adversaries in Iraq, the US is the only military power that can stop Xi Jinpings China taking over the Chinese democracy in Taiwan. The US still leads the world in tech, which is the coal and steel of our time. We watch French series on Netflix, buy German books on Amazon, contact African friends on Facebook, follow British politics on Twitter and search for criticism of the US on Google. In the development of AI, Europe is nowhere compared to China and the US.

Yet, especially given its domestic travails, the US cannot begin to cope on its own with a China that is already a multi-dimensional superpower. It needs that network of partners in Europe and Asia as much as they need it. So let the worlds democracies stand ready to grasp the outstretched hand of a good man in the White House. What a change that will be.

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What will President Biden's United States look like to the rest of the world? - The Guardian

European Union MPs write to EU President, ask for sanctions against Pakistan for admitting its role in Pulwama terror attacks – OpIndia

After the shocking admission of by Pakistan Minister for Science and Technology Fawad Chaudhry on the Pakistan govts role in the gruesome Pulwama attack that had claimed the lives of dozens of CRPF soldiers, Members of the European Parliament (MEP) condemned the blatant and brazen admission by Pakistan about the countrys involvement in the Pulwama terror attacks in India.

According to the reports, four Members of European Parliament Thierry Mariani, Julie Lechanteux, Virginie Joron, and France Jamet have written a strongly worded letter to President of European Commission, Ursula von der Leyen, urging the European Union to immediately consider sanctions on Pakistan and seek an investigation into its involvement in other similar attacks of terrorism in Europe.

We call on the European Commission and the European External Action Services to immediately condemn the leadership and government of the Islamic Republic of Pakistan for its participation in the Pulwama attacks and request the European Union to consider sanctions against those responsible, the MEPs said in the letter dated November 4.

The letter pointed out the shocking admission by Pakistans Federal Minister for Science and Technology, Fawad Chaudhry on October 29, who stood up in the Pakistan National Assembly and hailed the Pulwama terror attack as a success under Imran Khans government. The letter also mentions about Chaudhry crediting Pakistans Prime Minister, Imran Khan and the Tehreek-e-Insaf (PTI) party for Pulwama terror attack, who called it a great achievement.

The MEPs also said that Pakistan, under the control of successive political regimes and leaders, has been well documented as a country of State-Sponsored Terrorism.

The letter further stated that the recent admission for the Pulwama attacks comes less than six months after Pakistan PM Imran Khan hailed Osama Bin Laden as a martyr inside the Pakistani parliament.

At a time when then there is rising public insecurity from a global health pandemic, Europe, especially France have faced increasing threats of terrorism the MEPs stated.

In the face of such threats and horrific violent aggression on innocent people, it is essential that the European Union does not remain silent. Any admission of acts of terrorism, wherever they occur in the world, must face immediate denunciation and action by European leaders, the letter signed by four MEPs said.

In a shocking admission, the terror-state of Pakistan last week finally owned up to its involvement in carrying out the cowardly terror attacks in Pulwama last year, that killed at least 40 CRPF soldiers.

Speaking at the National Assembly, Pakistans Minister for Science and Technology Fawad Chaudhryadmittedhis countrys role in the barbaric 2019 Pulwama terrorattack. Responding to the oppositions criticism againstImran Taliban Khan-led government over its failure to respond to India, Fawad Chaudhry said that Pakistan gave a befitting reply to India by entering their territory and attacking them in Pulwama.

Humne Hindustan ko ghar main ghus ke maara(We hit India in their home). Our success in Pulwama is a success of the people under the leadership of Imran Khan. You and us are all part of that success, Fawad Chaudhry said in the national assembly.

We are proud that our brave sons (terrorists) entered their territory and attacked them in Pulwama. Even Indian media is ashamed to report about Pulwama incident, said Fawad Chaudhry as he boasted about Pakistans direct involvement in the deadly terrorist attack on CRPF convoy in Pulwama, Jammu and Kashmir on February 14, 2019.

The Pakistan Minister was referring to the suicide-attack unleashed by Pakistan-sponsored terrorist organisation Jaish-e-Mohammad on the convoy of CRPF soldiers.The shocking admission by an incumbent minister of the Pakistan government had exposed Pakistans direct support for Islamic terrorist groups.

After Pakistan admitted to having sponsored Pulwama terror attacks that killed more than 40 Indian security personnel, India is reportedly planning to approach the International Court of Justice (ICJ).

On the basis of the statement made by the Pakistani Minister, India has reportedly decided to approach the ICJ. The Indian government has also indicated that Pakistan should be put in the blacklist of the Financial Action Task Force (FATF).

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European Union MPs write to EU President, ask for sanctions against Pakistan for admitting its role in Pulwama terror attacks - OpIndia

Leaders Of Hungary And Slovenia, Stout Trump Allies In EU, Say U.S. Vote Isn’t Over – WOSU

Most European leaders are congratulating Joe Biden on Saturday for winning the U.S. presidency. Not Janez Jansa, prime minister of Slovenia, the alpine country in Eastern Europe where Melania Trump was born and raised.

Instead, Jansa attacked the media. He tweeted that the "#MSM (and not some official body) announced the winner." Jansa noted that "complaints have been filed" and said "the courts have not even begun to decide."

President Trump's attorneys have filed legal challenges in several states where Biden edged out the incumbent. Some have been thrown out, and others are pending.

Jansa, an anti-immigrant conservative, is one of the MAGA-style populists in Europe who endorsed Trump before the election. Jansa even cheered Trump on when the president prematurely declared victory long before the vote counting had finished.

Another Trump ally, Hungarian Prime Minister Viktor Orban, also did not congratulate Biden on Saturday. Origo, a pro-government news site controlled by Orban's allies, instead flashed a headline declaring "Chaos in America" and pointing out that "big media" declared Biden the victor.

Orban, the first European Union leader to back Trump in 2016, called the U.S. president a friend and predicted he would win reelection. Orban has accused the Democrats of "moral imperialism," and his government has recycled Trump attacks on Hunter Biden, Joe Biden's son.

Biden got a shoutout from at least one leader in Hungary: Budapest Mayor Gergely Karacsony said he hopes the new American leadership will help uphold democratic values.

"Trump was good for the Orban government," Karacsony wrote on his Facebook page. "President Biden will be good for Hungary."

Orban's main partner in the EU, Polish President Andrzej Duda a Trump ally who narrowly won reelection this year also acknowledged Biden's victory.

Duda applauded Biden "for a successful presidential campaign" and tweeted, "Poland is determined to upkeep high-level and high-quality PL-US strategic partnership for an even stronger alliance."

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Leaders Of Hungary And Slovenia, Stout Trump Allies In EU, Say U.S. Vote Isn't Over - WOSU

UK minister: Door ‘still ajar’ for post-Brexit talks with European Union – Economic Times

London: A senior British official said Sunday the door is "still ajar" for post-Brexit talks to continue with the European Union if officials in the bloc change their position on key points. Michael Gove's comments came after Prime Minister Boris Johnson's spokesman said Friday that the trade talks are "over" unless there is a "fundamental" change of position from the EU. With just weeks to go until the end-of-year deadline, Johnson said the U.K. needed to get ready for leaving the EU with no trade deal.

But Gove on Sunday left room for talks to agree on a deal so that the U.K. can avoid the high trade tariffs it faces from Dec. 31, when the transition period ends.

He accused EU officials of not being serious about making compromises, and said they would have to back down if chief EU negotiator Michel Barnier is to resume negotiations in London this week.

"We're certainly not saying that if they do change their position we can't talk to them," he told the BBC.

Britain officially left the EU on Jan 31, but remains part of its economic structures until Dec 31. The two sides have been trying to strike a deal on trade and other relations before then, but months of talks have been stalled on the issue of fishing and rules to ensure fair competition.

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UK minister: Door 'still ajar' for post-Brexit talks with European Union - Economic Times