Archive for the ‘European Union’ Category

Russia says its open to better ties with the European Union – PBS NewsHour

MOSCOW (AP) Russias top diplomat blamed the European Union Monday for a freeze in ties but argued that Moscow remains ready to mend relations if it hears positive signals from the bloc.

Foreign Minister Sergey Lavrov said after talks in St. Petersburg with his Finnish counterpart, Pekka Haavisto, that if the EU decides that its necessary to restore relations, we will be ready for it.

Lavrovs statement followed his warning last week that Moscow was ready for a split with the 27-nation bloc if Brussels moves to introduce new crippling sanctions that would hurt the Russian economy.

Russian-EU ties, which sank to post-Cold War lows after Moscows 2014 annexation of Ukraines Crimea and support for separatist insurgents in eastern Ukraine, took a new blow recently over the arrest of Russian opposition leader Alexei Navalny. The most prominent political foe of President Vladimir Putin was arrested Jan. 17 upon his return from Germany, where he spent five months recuperating from nerve agent poisoning he blamed on the Kremlin. Russian authorities have denied the allegations.

READ MORE: Russia moves to extinguish pro-Navalny flashlight protests

Russia has rejected U.S. and EU criticism of Navalnys arrest and imprisonment, and a sweeping crackdown on protests urging his release, as meddling in its internal affairs. Just as EU foreign policy chief Josep Borrell was visiting Russia earlier this month, Moscow announced the expulsion of diplomats from Germany, Poland and Sweden for attending protests in support of Navalny. The three EU nations expelled a Russian diplomat each in a quid pro quo response.

Haavisto emphasized the EUs strong criticism of the Russian action, noting that the EU diplomats were fulfilling their duty while observing the protests. He reaffirmed the EUs demand for Navalnys release and the blocs criticism of the crackdown on demonstrations.

Lavrov said that economic relations with the EU have been hurt by sanctions and political contacts have been limited to sporadic exchanges of views on international crises.

Little has been left of our relations, and our conversations focus on Syria, the Iranian nuclear program and some other international issues, he said. We remain ready to discuss any issues of mutual interest without trying to impose ourselves.

He added that while Russian-EU relations have stalled, Moscow has maintained strong bilateral contacts with individual EU members and will develop them further despite the damage inflicted by the sanctions.

Our relations with the EU dont matter when it comes to that, Lavrov said. The EU mustnt be mixed with Europe. We arent leaving Europe, we have plenty of friends in Europe and people who share our thoughts.

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Russia says its open to better ties with the European Union - PBS NewsHour

Pfizer and BioNTech to Supply the European Union with 200 Million Additional Doses of COMIRNATY – GlobeNewswire

NEW YORK and MAINZ, GERMANY, February 17, 2021 (GLOBE NEWSWIRE) Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced an agreement with the European Commission (EC) to supply an additional 200 million doses of COMIRNATY, the companies COVID-19 vaccine, to the 27 European Union (EU) member states. The EC has the option to request supply of an additional 100 million doses.

This new agreement is in addition to the 300 million doses that have already been committed to the EU through 2021 under the first supply agreement signed last year. The additional 200 million doses are expected to be delivered in 2021, with an estimated 75 million to be supplied in the second quarter.

The total number of doses to be delivered to the EU member states by the end of 2021 is now 500 million, with the potential to increase to 600 million based on the option granted in the new agreement.

We recognize that more people must be vaccinated as soon as possible to help defeat this virus and control the global pandemic. We are working relentlessly to support the further roll-out of vaccination campaigns in Europe and worldwide by expanding manufacturing capacity, said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. With this new agreement with the European Commission, we now expect to deliver enough doses to vaccinate at least 250 million Europeans before the end of the year.

Broad access to well-tolerated and highly efficacious vaccines is essential to halt the pandemic. We have taken additional steps to expand our manufacturing capacity to two billion doses in 2021, said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. We will initiate production at our Marburg facility this month and have strengthened our manufacturing network with additional partners. We are continuing to evaluate, together with governments, authorities and partners at all levels, how we might address an even higher future supply requirement for our vaccines.

COMIRNATY is being produced in BioNTechs and Pfizers manufacturing sites in Europe. The distribution of COMIRNATY by the EU member states will continue to be determined according to the populations identified in EU and national guidance. Globally, Pfizer and BioNTech aim to manufacture approximately two billion doses in total by the end of 2021, assuming continuous process improvements, expansion at current facilities, adding new suppliers and contract manufacturers and updated six-dose labeling.

The vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorizations Holder in the EU, and the holder of emergency use authorizations or equivalent in the United States, United Kingdom, Canada and other countries in advance of a planned application for full marketing authorizations in these countries.

AUTHORIZED USE IN THE EU: COMIRNATY (the Pfizer-BioNTech COVID-19 vaccine) has been granted conditional marketing authorisation by the European Medicines Agency to prevent coronavirus disease 2019 (COVID-19) in people from 16 years of age. The European Medicines Agencys (EMAs) human medicines committee (CHMP) has completed its rigorous evaluation of COMIRNATY, concluding by consensus that sufficiently robust data on the quality, safety and efficacy of the vaccine are now available.

IMPORTANT SAFETY INFORMATION:

For complete information on the safety of COMIRNATY always make reference to the approved Summary of Product Characteristics and Package Leaflet available in all the languages of the European Union on the EMA website.

The black equilateral triangle denotes that additional monitoring is required to capture any adverse reactions. This will allow quick identification of new safety information. Individuals can help by reporting any side effects they may get. Side effects can be reported to EudraVigilance or directly to BioNTech using email medinfo@biontech.de, telephone+49 6131 9084 0, or via the websitewww.biontech.de.

About Pfizer: Breakthroughs That Change Patients LivesAt Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at http://www.Pfizer.com. In addition, to learn more, please visit us on http://www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

Pfizer Disclosure Notice: The information contained in this release is as of February 17, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about Pfizers efforts to combat COVID-19, the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine, the BNT162 mRNA vaccine program and COMIRNATY, the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (including qualitative assessments of available data, potential benefits, expectations for clinical trials, supply agreements with the EC and the timing of delivery of doses thereunder, the anticipated timing of regulatory submissions, regulatory approval or authorization and anticipated manufacturing, distribution and supply) involving substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data (including the in vitro and Phase 3 data), including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the ability to produce comparable clinical or other results, including the rate of vaccine effectiveness and safety and tolerability profile observed to date, in additional analyses of the Phase 3 trial and additional studies or in larger, more diverse populations upon commercialization; the ability of BNT162b2 to prevent COVID-19 caused by emerging virus variants; the risk that more widespread use of the vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; the risk that preclinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when additional data from the BNT162 mRNA vaccine program will be published in scientific journal publications and, if so, when and with what modifications and interpretations; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when a Biologics License Application for BNT162b2 may be filed in the U.S. and whether and when other biologics license and/or emergency use authorization applications may be filed in particular jurisdictions for BNT162b2 or any other potential vaccines that may arise from the BNT162 program, and if obtained, whether or when such emergency use authorization or licenses will expire or terminate; whether and when any applications that may be pending or filed for BNT162b2 (including a potential Biologics License Application in the U.S.) or other vaccines that may result from the BNT162 program may be approved by particular regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccines benefits outweigh its known risks and determination of the vaccines efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; disruptions in the relationships between us and our collaboration partners or third-party suppliers; risks related to the availability of raw materials to manufacture a vaccine; challenges related to our vaccines ultra-low temperature formulation and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by Pfizer; the risk that we may not be able to successfully develop other vaccine formulations; the risk that we may not be able to create or scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand for our vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine within the projected time periods as previously indicated; whether and when additional supply agreements will be reached; uncertainties regarding the ability to obtain recommendations from vaccine technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; uncertainties regarding the impact of COVID-19 on Pfizers business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizers Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and in its subsequent reports on Form 10 -Q, including in the sections thereof captioned Risk Factors and Forward-Looking Information and Factors That May Affect Future Results, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available atwww.sec.govandwww.pfizer.com.

About BioNTechBiopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit http://www.BioNTech.de.

BioNTech Forward-looking StatementsThis press release contains forward-looking statements of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning: BioNTechs efforts to combat COVID-19; the collaboration between BioNTech and Pfizer regarding a COVID-19 vaccine; the ability of BNT162b2 to prevent COVID-19 caused by new virus variants; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the timing for submission of data for, or receipt of, any marketing approval or Emergency Use Authorization; our contemplated shipping and storage plan for BNT162b2 (COMIRNATY), including our estimated product shelf life at various temperatures; and the ability of BioNTech to supply the quantities of BNT162 to support clinical development and market demand, including our production estimate for 2021 and beyond as well as the timing and expectations of manufacturing capacities of the manufacturing network; discussions with government, regulatory authorities and partners to address future vaccine demand. Any forward-looking statements in this press release are based on BioNTechs current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: competition to create a vaccine for COVID-19; the ability to effectively scale our productions capabilities; and other potential difficulties.

For a discussion of these and other risks and uncertainties, see BioNTechs Quarterly Report for the Three and Nine Months Ended September 30, 2020, filed as Exhibit 99.2 to its Current Report on Form 6-K filed with the SEC on November 10, which is available on the SECs website at http://www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.

Pfizer Contacts:

Media RelationsAndrew Widger+44 1737 330909Andrew.Widger@Pfizer.com

Investor RelationsChuck Triano+1 (212) 733-3901Charles.E.Triano@Pfizer.com

BioNTech Contacts:

Media RelationsJasmina Alatovic+49(0)6131 9084-1513Media@biontech.de

Investor RelationsSylke Maas, Ph.D.+49 (0) 6131 9084 1074Investors@biontech.de

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Pfizer and BioNTech to Supply the European Union with 200 Million Additional Doses of COMIRNATY - GlobeNewswire

Epic Games extends legal fight against Apple to the European Union – ZDNet

Epic Games has filed another antitrust complaint against Apple, this time in the European Union.

Filed with the European Commission, Epic has accused the iPhone maker of enforcing a "series of carefully designed anti-competitive restrictions" that have harmed competition when it comes to app distribution and payment processes.

"Apple uses its control of the iOS ecosystem to benefit itself while blocking competitors and its conduct is an abuse of a dominant position and in breach of EU competition law," Epic Games said in anannouncement.

In the announcement, Epic Games said Apple's decision to block Fortnite -- a popular game created by the games developer -- from the iOS platform has harmed the company. It added that Apple has since launched its own gaming distribution service, Apple Arcade, while allegedly barring Epic Games from the doing the same.

"Consumers have the right to install apps from sources of their choosing and developers have the right to compete in a fair marketplace. We will not stand idly by and allow Apple to use its platform dominance to control what should be a level digital playing field," Epic Games founder and CEO Tim Sweeney said.

"It's bad for consumers, who are paying inflated prices due to the complete lack of competition among stores and in-app payment processing. And it's bad for developers, whose very livelihoods often hinge on Apple's complete discretion as to who to allow on the iOS platform, and on which terms."

Prior to this latest complaint, Epic Games already had legal processes underway in Australia, the US, and the UK that specifically targeted Apple's app distribution and payment processes.

Much like the legal stoushes in those jurisdictions, Epic Games said it is not seeking damages from Apple in its EU complaint. Instead, it has asked the European Commission to "address Apple's anti-competitive conduct by imposing timely and effective remedies".

The standoff between Epic Games and Apple commenced six months ago, when Apple and Google blocked Fortnite from their app stores after Epic Games implemented anin-app payment systemwithin the game to circumvent paying the 30% commission fee of those stores.

This sparked Epic's original US lawsuit that was brought against Apple and Google, which accused the tech giants of conducting anti-competitive and monopolistic practices.

"Apple has become what it once railed against: The behemoth seeking to control markets, block competition, and stifle innovation. Apple is bigger, more powerful, more entrenched, and more pernicious than the monopolists of yesteryear. At a market cap of nearly $2 trillion, Apple's size and reach far exceeds that of any technology monopolist in history," Epic said in the originating claim.

Apple then countersued Epic Games in September, accusing the game developer of attempting to pay nothing for the value it derived from being in the App Store by implementing its own in-app payment system.

The iPhone maker also raised another lawsuit accusing Epic of charging others for access to Apple's intellectual property and technologies through the in-app payment system, as well as for preparing a "smear campaign" against the company. This lawsuit, however, was quickly thrown out by the US court.

In the months that followed, Epic Games raised its Australian and UK lawsuits against Apple. In both instances, Epic said it was extending the battle to make digital platforms fairer for consumers and developers.

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Epic Games extends legal fight against Apple to the European Union - ZDNet

Looking forward to early organisation of Assembly polls in J&K: European Union – The Tribune

New Delhi, February 19

The European Union on Friday said it had taken note of recent steps such as district council elections and the resumption of 4G Internet services in Jammu and Kashmir, and was looking forward to a number of other important steps, including the early organisation of the Legislative Assembly polls.

The comments by a spokesperson of the EU came a day after a group of 24 diplomats from the 27-member bloc returned from a two-day visit to Jammu and Kashmir.

The visit presented the opportunity to see the situation on the ground and interact with local interlocutors as part of the EU's outreach to all stakeholders, the official said, adding the EU look forward to continuing its dialogue with India on it.

"We have taken note of recent steps such as the election of district development councils and the resumption of 4G internet services. The right to freedom of expression online and offline is a key value for all democracies," the spokesperson added.

"We look forward to a number of other important steps to be taken in the political and economic sphere, including the early organisation of the Legislative Assembly elections," the spokesperson said.

The statement was released by the EU mission in Delhi in response to queries about the visit of EU envoys to the Union Territory of J&K.

The EU spokesperson also said the EU ambassador to India and several envoys of EU member states, among other countries, participated in the visit to J&K Kashmir on February 17-18 on invitation of the Ministry for External Affairs (MEA), and the programme included meetings with civil and military authorities, some newly elected political representatives, and selected representatives of civil society.

MEA spokesperson Anurag Srivastava on Thursday said the visit by 24 foreign envoys to J&K was aimed at enabling them to witness the Union Territory's march on the path of inclusive development and the dynamism in the grass roots democratic institutions following the successful conduct of the recent local elections. PTI

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Looking forward to early organisation of Assembly polls in J&K: European Union - The Tribune

EUs China dilemma is a sign of things to come – Hindustan Times

After the end of the Cold War, the world grew accustomed to the notion of a single global economy, one in which political barriers were a secondary concern or applicable only to those countries adopting a deliberate policy of isolation.

Such one-world globalism was not a novel consideration. A similar idealism was a feature towards the end of World War II at the Yalta Conference, the establishment of the United Nations, and even the Bretton Woods Conference that persisted until early 1947. As historian Benn Steil has written, events came to a head that year. Leaders in the United States (US) concluded that the post-War European recovery could no longer rely on the free flow of commerce with a Soviet sphere of influence. The result was the division of the European and world economy, and the creation of the Marshall Plan, General Agreement on Tariffs and Trade (GATT), and the European Coal and Steel Community.

Europe is once again the primary testing ground for the future cohesion of the international economy. The European Union (EU) remains one of the worlds three largest concentrations of economic activity, along with the US and China. Decisions taken by the EU and Germany in particular will have major ripple effects on much of the rest of the world.

The persistent assumption among elites in both North America and Europe was that, despite its many differences, the North Atlantic economy would remain something of a cohesive whole. It reflected shared values and history and was characterised by dense networks of exchange and institutions. Recent attempts at advancing European strategic autonomy, led by French President Emmanuel Macron, might rankle with Americans, much as Gaullism and Ostpolitik once did. But concerns in Washington are growing that transatlantic divides on global economic issues go beyond a quest for autonomy.

Such concerns were apparently realised after the finalisation, in principle, of a Comprehensive Agreement on Investment (CAI) between EU and China in December. The CAIs supporters argue that the agreement had long been under negotiation; that it did not mark a capitulation on such matters as foreign direct investment screening, export controls, or disinformation; and that it ensures better market access, a level-playing field, and sustainability objectives in China.

But the voices of criticism within Europe particularly among the strategic community have been overwhelming. The criticism has less to do with the economic implications there are devils in the details and Chinas commitments are questionable. But the agreement was nonetheless an unambiguous political victory for Beijing, which may explain why Xi Jinping himself reportedly intervened to ensure a favourable outcome. At the same time, the brunt of criticism has been directed less at Brussels and more at Berlin, which is accused of having pushed through the deal for the narrow benefit of German manufacturing and telecommunications corporations.

Less than two weeks before CAI was agreed upon, US national security adviser-designate Jake Sullivan rather unusually took to Twitter to voice concern and suggest a delay before concluding the deal. The Biden-Harris administration would welcome early consultations with our European partners on our common concerns about Chinas economic practices, he wrote. While European leaders had previously indicated that their troubles with the US were a consequence of former President Donald Trumps contemptuous attitude, the failure to work with a new US administration despite such public entreaties suggests deeper discontent.

There are some important countervailing trends to suggest that Europes present rift with Washington is not irreparable and that its relationship with Beijing is not without its own challenges. The first is an unanticipated consequence of Brexit. The Biden administrations frustration with Brussels has resulted in unexpected cooperation with the Boris Johnson government in London, which has independently reached its own conclusions about Beijing. The second is an impending leadership transition in Berlin, given the outsized role that Germany played in CAI. Third, Chinese efforts in Europe have also struggled. The recent 17+1 summit a format once perceived as undermining European cohesion saw some participating countries downgrading their involvement. Other matters, such as the detention of two Canadians by China and developments in Hong Kong and Xinjiang have contributed to unified positions staked by European governments with their American counterparts.

Amid these turbulent undercurrents, the European private sector recognises the dilemma it now faces. The ability to integrate supply chains, innovation streams, data, critical components, and finance with both the US and China appears increasingly untenable. This will, over time, prove costly, hampering efficiency, knowledge, and economies of scale. The dilemma is not unique.

In both the US and India, the political consensus has shifted gradually away from economic over-dependence on China. In Indias case, it has resulted in specific outcomes a drop in Chinese imports, greater investment scrutiny, and restrictions on digital apps and public procurement.

The evolution from a one-world economy to a two-world system with its many redundancies will, unlike the post-World War II era, be long-drawn-out and costly. The differences between States, even close allies, are real but not necessarily insurmountable. Instead, greater engagement between national security communities and the private sector may be the need of the hour.

Dhruva Jaishankar is executive director, ORF America

The views expressed are personal

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EUs China dilemma is a sign of things to come - Hindustan Times