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Samsung Bioepis and Biogen Announce FDA Filing Acceptance of SB11, A Proposed Biosimilar Referencing Lucentis® (ranibizumab)

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Samsung Bioepis and Biogen Announce FDA Filing Acceptance of SB11, A Proposed Biosimilar Referencing Lucentis® (ranibizumab)


Samsung Bioepis and Biogen Announce FDA Filing Acceptance of SB11, A Proposed Biosimilar Referencing Lucentis® (ranibizumab) – Book Publishing Industry Today – EIN Presswire




















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Opening remarks by Commissioner Gentiloni at the read-out of the College meeting and press conference on the European Semester Autumn Package

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European Commission Speech Brussels, 18 Nov 2020 Good morning. Our Autumn Package is based on the economic forecast we presented a couple of weeks ago.
Our view is that we are not having a “v-shaped&rdqu…

Opening remarks by Executive Vice-President Dombrovskis at the read-out of the College meeting and press conference on the European Semester Autumn Package

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European Commission Speech Brussels, 18 Nov 2020 Now that Europe is caught up in the second wave of the pandemic, we are again facing a very deep socio-economic impact.
It is a difficult time for everyone. All…

REACT-EU: additional support of €47.5 bn agreed to address impact of COVID-19 | News | European Parliament

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REACT-EU: additional support of €47.5 bn agreed to address impact of COVID-19  | News | European Parliament

, https://www.europarl.europa.eu/news/en/press-room/20201113IPR91597/

Backed by space technology, Asia-Pacific countries power sustainable development

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Backed by space technology, Asia-Pacific countries power sustainable development

Released on Wednesday, UN Economic and Social Commission for Asia and the Pacific (ESCAP) report Geospatial Practices for Sustainable Development showcases examples from the region’s countries employing applications of space technology to advance sustainable development.  

“Night-light” satellite images monitoring the impact of lockdowns, “heatmaps” to chart out communities vulnerable to the pandemic and its socio-economic consequences, real-time situational analysis, and dashboards integrating a wide gamut of critical information to support decisions are some of the practices cited. 

The examples, according to the report, show how space applications and geospatial data have played an important role in providing essential location-based and temporal data to make an “overall data map” and snapshots on the COVID-19 pandemic for policymakers and the public. 

Strengthening resilience 

In addition, combining spatial data from contact tracing, quarantining, and social distancing with digital solutions and artificial intelligence (AI)-driven risk analytics can help enhance community resilience. 

Such applications can also help in the recovery phase to build back better, by providing an evidence base for decisions on the easing of lockdown and the resumption of economic and social activities, the report added. 

“The effective integration of geospatial data, with existing statistics and ground-based information, will be key to delivering the timely data needed for governments, businesses, communities and citizens to make evidenced-based decisions”, said Armida Salsiah Alisjahjabana, Executive Secretary of ESCAP. 

The report, issued two years after Asian and Pacific countries endorsed an ambitious plan of action on use of space technologies to support sustainable development also provides a baseline for assessing future progress in the region. 

Importance of partnerships 

In addition to presenting an overview of the status along thematic areas such as disaster risk, natural resource management, connectivity, social development, energy, and climate change, the report also highlights the importance of multi-stakeholder partnerships.  

“Many regional and country-based efforts are sparking innovations that attract both public and private capital, supporting start-ups and spinoffs from space applications research and pilots,” said ESCAP.  

The report outlined seven key recommendations for policymakers to integrate applications of geospatial information into their planning and actions towards achieving the Sustainable Development Goals (SDGs). 

These include investments to cultivate national experts; incorporating geospatial information into national institutions and platforms; integrating geospatial data with other data sources; employing geospatial data to create, implement and monitor policies; ensuring privacy, safety and ethics of data; providing open data access; and encouraging local to international collaborations. 

South Sudan: European Union boosts resilience in Northern and Western Bahr el Ghazal states

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South Sudan: European Union boosts resilience in Northern and Western Bahr el Ghazal states

JUBA – The United Nations World Food Programme (WFP) welcomes a €6.1 million contribution from the European Union to strengthen the resilience of vulnerable communities in Northern and Western Bahr El Ghazal states.

The funds will provide a four-year project to transform the livelihoods of 10,000 vulnerable households through capacity building and providing agricultural inputs and tools to increase production, reduce food losses and enhance access to markets.

“The EU infrastructure development programme, for which the EU has mobilised a total of €16 million under the EU Emergency Trust Fund for Africa, complements and builds synergies with previous and current EU-funded interventions in the mentioned states, where priority rural infrastructures have been already constructed and are in use,” said European Union Ambassador Christian Bader.

“This programme not only addresses connectivity and food security, but also fundamental values and issues critical for a sustainable and inclusive socio-economic development such as: promotion of social cohesion, peacebuilding, gender equality, human rights protection, job creation for youths and women, enhanced incomes for poor vulnerable households and, last but not least, environmental safeguards,” he added.

“We are grateful to the European Union for its commitment to supporting vulnerable communities. The empowerment of smallholder farmers is integral to fighting food insecurity and driving economic development,” says Matthew Hollingworth WFP Country Director in South Sudan.

WFP fights food insecurity, restores livelihoods of rural populations, eliminates isolation and inequity in South Sudan through resilience building programmes such as Smallholder Agriculture Market Support (SAMS). SAMS increases agricultural production and productivity, reduce food losses and boost farm-to-market access in areas with agricultural potential and to improve rural connectivity to social services.

In the 2019-2020 harvest, WFP trained more than 10,500 smallholder farmers— 35 percent of whom were women—and distributed over 30,000 post-harvest handling materials. WFP also bought over 677 metric tons of maize, valued at over US$250,000, directly from smallholder farmers.

The European Union is a long-standing WFP partner, supporting its emergency and development work in South Sudan. It has contributed €152 million to WFP’s operations in the country over the past five years

#

The United Nations World Food Programme is the 2020 Nobel Peace Prize Laureate. We are the world’s largest humanitarian organization, saving lives in emergencies and using food assistance to build a pathway to peace, stability and prosperity for people recovering from conflict, disasters and the impact of climate change.

Follow us on Twitter @WFP_SouthSudan and @WFP_Africa

For more information please contact (email address: [email protected]):

Marwa Awad, WFP/Juba, [email protected] Mob. + 211 92 622 1460

EU court cuts Lithuanian Rail’s EU antitrust fine by a third

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EU court cuts Lithuanian Rail's EU antitrust fine by a third

BRUSSELS, Nov 18 (Reuters) – Lithuanian Rail on Wednesday had its 27.9 million euro ($33 million) EU antitrust fine cut by a third though Europe’s second-top court backed EU enforcers’ ruling that it had hindered competition by removing a track running to Latvia.

The European Commission in its 2017 decision said it was unacceptable that the operator removed the 19-kilometre (12 mile) stretch of track in 2008 after Polish oil company PKN Orlen wanted to redirect its freight to Latvian ports from its refinery in Lithuania by using another rail operator and a short route to the border.

Lithuanian Rail subsequently challenged the ruling at the Luxembourg-based General Court. Judges took the EU competition enforcer’s side.

“The Commission made no error in determining that removal of a railway track before the renovation works had even begun constituted highly unusual conduct in the rail sector,” the court said.

It however cut the fine to 20.07 million euros, citing its jurisdiction in this area and the gravity and duration of the operator’s wrongdoing.

$1 = 0.8418 euros Reporting by Foo Yun Chee, editing by Louise Heavens

Politics Isn’t Religion

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Politics Isn’t Religion

… it.  
Politics isn’t religion.  Meaning, politics shouldn’t … endeavor in life.  Religion is something toward which … culture replace Christianity, or religion more broadly, with politics. … culture replace Christianity, or religion more broadly, with politics. …

Estimated net sales of SEK 850-1,050 million and SEK 300-400 million in operational EBIT added during FY 2021/2022

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Estimated net sales of SEK 850-1,050 million and SEK 300-400 million in operational EBIT added during FY 2021/2022

STOCKHOLM, Nov. 18, 2020 /PRNewswire/ — Embracer Group AB (“Embracer”) and its subsidiaries have as previously communicated this morning entered into 13 acquisition agreements (the “Acquisitions”). The acquired businesses are, during the financial year ending 31 March 2022, expected to contribute to Embracer Group’s net sales in the range of SEK 850-1,050 million and contribute to operational EBIT in the range of SEK 300-400 million. In addition, during FY 2021/2022 the expanded studio footprint is expected to bring savings on capitalized game development in the range of SEK 50-100 million. The combined operational EBIT and savings on game development are expected to be in the range of SEK 350-500 million and this profitability is expected to grow in the following years as more game development projects will be completed.

The aggregated day one purchase price for the Acquisitions amounts to approximately SEK 2.0 billion on a cash and debt free basis. Approximately SEK 1.7 billion is paid in cash and SEK 0.3 billion in newly issued Embracer B shares with a maximum additional consideration amounting to SEK 1.8 billion, which is subject to fulfilment of agreed milestones, both operational and financial, over a period of up to 10 years. The additional consideration comprise a maximum of approximately SEK 0.9 billion which may be paid in cash and a maximum approximately SEK 0.9 billion to be paid in Embracer B shares at a price corresponding to the volume weighted average price per Embracer B share at Nasdaq First North Growth Market during 20 trading days up until and including the date of signing of the Acquisitions (VWAP 20). The aggregated maximum consideration amounts to SEK 3.8 billion.

The total number of shares that are issued as part of the aggregate consideration, excluding shares issued as part of earn-out structures, amounts to approximately 1,723,000 Embracer B shares issued at a price of approximately SEK 174 per B share. The part of the additional consideration consisting of Embracer B shares amounts to a maximum of approximately 5,170,000 shares provided that all earn out targets are met. Approximately 1,367,000 B shares being part of the additional consideration are issued at closing of the Acquisitions and subject to such as claw back rights and lock-up restrictions. A maximum of approximately 3,803,000 B shares may be issued in the future as additional consideration subject to fulfillment of certain targets. The share issues are made pursuant to the authorization granted by the extra general meeting held on 16 November 2020.

The Acquisitions

All of Embracer’s operating units – THQ Nordic, Deep Silver/Koch Media, Coffee Stain, Amplifier Games Invest, Saber Interactive and Deca Games – are making bolt-on acquisitions. Embracer onboards more than 1,250 experienced and talented people, strengthens its developer footprint in Eastern Europe as well as its development and UA capabilities within free-to-play. In most of the transactions, earn-outs and management incentives over 5-10 years, have been put in place to ensure long term alignment with the founders and management teams joining Embracer.

The announced Acquisitions are aligned with Embracer’s growth strategy and is enabled by the group’s decentralized operating model. Over the past three years, Embracer has expanded from one to six operating units. Each of these operating units have put in place their own M&A agenda with the purpose of adding additional organic growth opportunities and to improve long term profit and cash flow generation. For Embracer’s decentralized operating model to be sustainable and scalable, it is a necessity that most acquisitions are originated and onboarded on the operating unit level. For the Embracer operating model with emphasis on decentralized decision making and independence for local management to work, it is also necessary that founders and management of acquired companies join Embracer with a long-term mindset.

Through the Acquisitions, Embracer Group grows to 58 internal studios and more than 5,700 employees and contracted employees in more than 45 countries.

Embracer’s inhouse developer footprint is expanded by 767 developers, equivalent to a 30 percent increase and brings the total number of internal developers to 3,318. The total headcounts within the group increases to more than 5,700 employees and contracted employees following the Acquisitions. The management depth is further extended by the addition of strong business leaders and local management teams with an impressive track record, where many of the acquired companies are leading premium games developers in their respective countries.

Deca Operating Unit will triple in size in terms of revenues and employees

Embracer entered the free-to-play games segment with the acquisition of Deca Games in August 2020. Today, the Deca Operating Unit is established with the addition of A Thinking Ape and IUGO, two studios based in Canada. Embracer estimate the new Deca Operating Unit will triple in size in terms of revenues and employees and create a full scale free-to-play operation with expertise across IP origination, game development, marketing, user acquisition and live operations. Deca Games, A Thinking Ape and IUGO will continue to operate as independent companies within the Deca Operating Unit free-to-play ecosystem with their respective management teams continuously responsible for day-to-day operations. Founders and management across these businesses have a long term alignment with Embracer and shares a passion for creating a substantial free-to-play business over time through a combination of organic growth and by welcoming more FTP gaming entrepreneurs to the Embracer family.

Embracer Group’s capital allocation strategy are essential for continued growth

The capital allocation priorities for Embracer are unchanged. The first priority for allocation of operational cash flow from released games to reinvest as much as possible into value enhancing organic growth opportunities, e.g. new game projects. The second priority is to use free cash flow to finance, bolt-on acquisitions in the operating units.

Embracer reiterates the ambition to maintain a strong balance sheet and strives to maintain a net cash position to maintain maximum strategic flexibility. For the right inorganic growth opportunity, financial leverage could temporarily exceed 1,0x operational EBIT to net debt, where operational EBIT is measured as management expectations for the coming twelve months. In such circumstances, leverage should at least return to below 1,0x net debt to operational EBIT over the medium term, either by retaining cash from operations or by raising primary capital in the equity market.

Cash at hand and available credit facilities post the cash payment of the Acquisitions amounts to more than SEK 8.5 billion. Furthermore, on 16 November 2020, the extra general meeting authorized the board of directors to issue B shares in the amount not exceeding ten (10) percent of the total number of shares in the Company at the time when the authorization is used the first time to fund acquisitions, parts of this mandate has been used according to the Acquisitions. The ambition is to continue to partly fund acquisitions with equity to create long term alignment with founders and management joining Embracer.

The shares and dilution

Through the Acquisitions, Embracer may in aggregate issue, including earn-out consideration shares, a total of approximately 6,893,000 shares, meaning that the number of shares in Embracer can increase from 421,139,665 to approximately 428,032,665 B shares, and that the number of votes can increase from 721,731,898 to approximately 728,624,898.

The total number of shares that are issued as part of the aggregate consideration, excluding shares issued as part of earn-out structures, are issued at a price of approximately SEK 174 per B share.

The part of the additional consideration for the Acquisitions consisting of Embracer B shares amounts to a maximum of approximately 5,170,000 shares provided that all earn out targets are met. Approximately 1,367,000 B shares being part of the additional consideration are issued at closing of the Acquisitions and subject to such as claw back rights and lock-up restrictions. A maximum of approximately 3,803,000 B shares may be issued in the future as additional consideration subject to fulfillment of certain targets. All earn-out shares are issued at a price of approximately SEK 174 per B share.

The Acquisitions will, if all earn-out consideration shares are issued, lead to a dilution of approximately 1.61 percent of the share capital and approximately 0.95 percent of the votes in Embracer based on the number of shares and votes in Embracer following completion of the Acquisitions and issuance of all earn-out consideration shares.

All shares issued as part of the consideration for the Acquisitions, excluding the earn-out consideration shares, are issued based on the authorization from the extra general meeting on 16 November 2020.

Advisers

Ernst & Young AB is providing transaction support and Baker McKenzie is acting as legal counsel to Embracer in connection with the Acquisitions.

Responsible party

This information constitutes inside information that Embracer Group AB is obliged to make public in accordance with the (EU) Market Abuse Regulation 596/2014. The information in this press release has been made public through the agency of the responsible person set out below for publication at the time stated by Embracer Group’s news distributor Cision at the publication of this press release. The responsible person below may be contacted for further information.

For additional information, please contact:

Lars Wingefors, Co-founder and Group CEO Embracer Group AB

Tel: +46 708 47 19 78

E-mail: [email protected]

About Embracer Group

Embracer Group is the parent company of businesses developing and publishing PC, console and mobile games for the global games market. Embracer Group has an extensive catalogue of over 190 owned franchises, such as Saints Row, Goat Simulator, Dead Island, Darksiders, Metro, MX vs ATV, Kingdoms of Amalur, TimeSplitters, Satisfactory, Wreckfest, Insurgency and World War Z, amongst many others.

With its head office based in Karlstad, Sweden, Embracer Group has a global presence through its six operative groups: THQ Nordic GmbH, Koch Media GmbH/Deep Silver, Coffee Stain AB, Amplifier Game Invest, Saber Interactive and DECA Games. Embracer Group has 46 internal game development studios and is engaging more than 4,000 employees and contracted employees in more than 40 countries.

Embracer Group’s shares are publicly listed on Nasdaq First North Growth Market Stockholm under the ticker EMBRAC B with FNCA Sweden AB as its Certified Adviser; [email protected] +46-8-528 00 399.

Subscribe to press releases and financial information:

https://embracer.com/investors/subscription/

For more information, please visit: https://www.embracer.com

Important information

The release, announcement or distribution of this press release may, in certain jurisdictions, be subject to restrictions. The recipients of this press release in jurisdictions where this press release has been published or distributed shall inform themselves of and follow such restrictions. The recipient of this press release is responsible for using this press release, and the information contained herein, in accordance with applicable rules in each jurisdiction. This press release does not constitute an offer, or a solicitation of any offer, to buy or subscribe for any securities in Embracer Group in any jurisdiction, neither from Embracer Group nor from someone else.

This announcement does not identify or suggest, or purport to identify or suggest, the risks (direct or indirect) that may be associated with an investment in Embracer’s shares. Any investment decision regarding Embracer’s shares must be made on the basis of all publicly available information relating to the company and the company’s shares. The information contained in this announcement is for background purposes only and does not purport to be full or complete. No reliance may be placed for any purpose on the information contained in this announcement or its accuracy or completeness. This announcement does not constitute a recommendation. Each investor or prospective investor should conduct his, her or its own investigation, analysis and evaluation of the business and data described in this announcement and publicly available information. The price and value of securities can go down as well as up. Past performance is not a guide to future performance.

Forward-looking statements

This press release contains forward-looking statements that reflect the company’s intentions, beliefs, or current expectations about and targets for the company’s future results of operations, financial condition, liquidity, performance, prospects, anticipated growth, strategies and opportunities and the markets in which the company operates. Forward-looking statements are statements that are not historical facts and may be identified by words such as “believe”, “expect”, “anticipate”, “intend”, “may”, “plan”, “estimate”, “will”, “should”, “could”, “aim” or “might”, or, in each case, their negative, or similar expressions. The forward-looking statements in this press release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although the company believes that the expectations reflected in these forward-looking statements are reasonable, it can give no assurances that they will materialize or prove to be correct. Because these statements are based on assumptions or estimates and are subject to risks and uncertainties, the actual results or outcome could differ materially from those set out in the forward-looking statements as a result of many factors. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this release by such forward-looking statements. Embracer does not guarantee that the assumptions underlying the forward-looking statements in this press release are free from errors and readers of this press release should not place undue reliance on the forward-looking statements in this press release. The information, opinions and forward-looking statements that are expressly or implicitly contained herein speak only as of its date and are subject to change without notice. Neither the Embracer nor anyone else undertake to review, update, confirm or to release publicly any revisions to any forward-looking statements to reflect events that occur or circumstances that arise in relation to the content of this press release, unless it is not required by law or Nasdaq First North Growth Market’s rule book for issuers.

This information was brought to you by Cision https://news.cision.com

https://news.cision.com/embracer-group-ab/r/estimated-net-sales-of-sek-850-1-050-million-and-sek-300-400-million-in-operational-ebit-added-durin,c3239076

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SOURCE Embracer Group AB

EU Bishops call for solidarity and hope on path towards better future – Vatican News

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EU Bishops call for solidarity and hope on path towards better future - Vatican News

By Vatican News staff writer

The Bishops of Europe have addressed a message of hope and a call to solidarity to European Institutions and Member states amid the health crisis that has overwhelmed the world these past months.

In a message released on Wednesday under their umbrella body, COMECE, they reiterated their commitment to the construction of Europe and to its founding values of “solidarity, freedom, inviolability of the human dignity, democracy, rule of law, equality and defence and promotion of human rights.”

Inspired by Christian faith, which “is the ultimate foundation of our hope and universal brotherhood,” the Bishops also reaffirm their will to strive, together with other sister Churches and ecclesial communities, to “build a universal fraternity that leaves no one out.”

The Covid-19 pandemic

Highlighting some of the wide-ranging effects of the Covid-19 health crisis, they noted that the pandemic has shaken many “previous securities and has revealed our vulnerability and our interconnectedness.”

Many, the Bishops noted, were worried that the EU itself “as an economic, political, social and cultural project, was at risk.”

However, propelled by the realization that everyone is in the same boat and we can only save ourselves by staying together, the EU is demonstrating its capacity to rediscover the spirit of the Founding Fathers and is beginning to respond in a united manner. This spirit, the Bishops hope, will be reflected in the Covid-19 recovery instrument and the reinforced EU budget for 2021 – 2027.

A new mindset

The future of the European Union does not depend only on economy and finance, but also on a common spirit and a new mindset, the Bishops stressed.

In this regard, efforts should not be simply devoted to returning to the “old normal.” Instead, the continent must take advantage of the crisis to bring about a “radical change for the better” by rethinking the present models of globalization, guaranteeing respect for the environment, openness to life, social equality, protecting the dignity of workers and the rights of future generations.

The Bishops also pointed out that Pope Francis’ Encyclicals Laudato sí and Fratelli tutti can be a source of inspiration for shaping a new civilization. In Fratelli tutti, the Bishops note, Pope Francis “calls on the whole of humanity to universal brotherhood and social friendship, not forgetting those on the margins, wounded and suffering”. At the same time, the principles of Catholic Social Teaching, with their emphasis on human dignity, solidarity, preferential option for the poor and sustainability, can guide the path to building a different economic model in a post-pandemic society.

Solidarity

COMECE stressed the importance of solidarity as a fundamental principle of the Social Doctrine of the Church as well as being at the core of the European Integration process.

Solidarity, the Bishops said, “is to be understood in terms of ‘doing together’ and as ‘being open to integrate everyone’,” including those on the margins.

In this light, the Bishops appealed for the Covid-19 vaccine, when it becomes available, to be accessible to all, especially to the poor. They also called for increased humanitarian aid and development cooperation, and for military spending to the redirected towards health and social services.

Care for Migrants and refugees

The European Bishops noted that solidarity towards refugees should not only involve funding but extended to include “opening up the borders of the European Union proportionally by each Member State.”

They proposed that the Pact on Migration and Asylum presented by the EU can be a step toward establishing a common and just policy on migration. However, they said, it must also be carefully evaluated. Besides, certain principles and international legal obligations have to be respected “regardless of the persons involved.”

On this issue, the Bishops recommend collaboration with Church institutions and private associations already working in this field.

They further stressed the respect for the freedom of religion of believers, in particular, “the freedom to gather together to exercise their freedom of worship, in full respect of sanitary requirements” during the pandemic.

Post-pandemic society

During these months of pandemic, the Bishops note that they have witnessed “so many signs that open us up to hope,” from the work of health personnel, to caregivers for the elderly and the gestures of ecclesial communities – notwithstanding the difficult moments, including times of suffering, loneliness and sometimes, death.

The Bishops recalled Pope Francis’ Urbi et Orbi message on Easter Sunday when he noted that Europe was able to rise again and overcome the rivalries of the past after the Second World War. For the Pope, they noted, it is important that “these rivalries do not regain force, but that all recognize themselves as part of a single family and support one another.”

Therefore, whether the world will be better or worse after the crisis, or whether we will come out strengthened in solidarity or not, the depends on us, the Bishops stressed.

Concluding, the European Bishops expressed their hope that Europe can come out from this crisis “stronger, wiser, more united, exercising more solidarity, caring more for our common home, being a continent that pushes the whole world forward towards greater fraternity, justice, peace and equality.”