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On 11 November 2021, the Council adopted Decision (CFSP) 2021/19651.

The Council has decided that the restrictive measures should be renewed for a further period of 12 months, until 14 November 2022. The Council also decided to amend the statement of reasons of twenty-six persons listed in Annex I to Decision (CFSP) 2017/2074.

The Candidate Countries The Republic of North Macedonia, Montenegro, Serbia and Albania2 and the EFTA countries Iceland and Liechtenstein, members of the European Economic Area, as well Georgia align themselves with this Council Decision.

They will ensure that their national policies conform to this Council Decision.

The European Union takes note of this commitment and welcomes it.

1Published on 12.11.2021 in the Official Journal of the European Union L 400/148.

2The Republic of North Macedonia, Montenegro, Serbia and Albania continue to be part of the Stabilisation and Association Process.

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Declaration by the High Representative on behalf of the EU on the alignment of certain countries concerning restrictive measures in view of the...

"Achieving the climate goals requires difficult decisions, but we must take these steps to save the planet and the environment," said Prime Minister Kaja Kallas. "In the long run, investing in the green transition is also an opportunity to stabilise energy prices, reduce energy dependency, make the economy and administration more sustainable and the environment cleaner. Most importantly, in implementing the climate goals we must ensure that our people are taken care of and are not suffering from these changes. It must be a green transition of the people," said Kallas.

According to the Minister of the Environment, Erki Savisaar, the positions were composed by the ministry in close collaboration with other ministries, since the proposals also have a strong impact on industry, transportation, agricultural and forestry sectors. "In the negotiations we want to ensure that there are secured measures for stabilising price fluctuations of greenhouse gas emission allowance units," assured Savisaar. "We support the Commission's proposal to raise the goal for greenhouse gas emissions reduction, however, these changes must be as smooth as possible to ensure investment security for the enterprises."

It is important for Estonia that complying with the climate goals is based on the principle that each Member State can autonomously find efficient ways in which to achieve the goals and that the profit gained from the sale of their emission allowance units is directed into greenhouse gas emissions reduction related activities. To prevent carbon leakage, it is important that in complying with the climate goals the free allocation of emission allowance is continued in those sectors to which carbon border measures are not applied, such as shale oil production. It is equally important that the negative effects of the changes are as small as possible and to ensure that new opportunities are being investigated to alleviate said effects on the less ensured, as well as to come up with support measures.

In the maritime sector it is necessary to cease efforts of forming global deals about the reduction of the sector's carbon emissions in the International Maritime Organisation. In agreeing on the European Union's new rules, it is important to ensure that the sector remains competitive in Estonia and other countries, as well as the equal treatment of ships as compared to third countries. In addition, Estonia supports the proposal of the European Commission to end the allocation of free emission units to air service providers by the year 2027. Estonia also supports the revision of established emission standards and the setting of stricter standards for new cars and small commercial vehicles. At the same time, it is important to keep in mind that gas powered public transport and heavy trucks must be able to be brought to the market even after 2035 to support the use of biomethane as an environmentally friendly fuel in transportation.

Compared to the year 1990, the EU has reduced its greenhouse gas emissions by 31%. To achieve climate neutrality by 2050 at a smooth and reasonable pace, it is necessary to reduce the overall EU gas emissions by 55% by the year 2030. The Riigikogu will followingly discuss the positions approved by the government. If the positions are approved by the Riigikogu, they will become Estonia's starting position for discussions in the EU Council.

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The Government approved standpoints on European Union climate proposals - marketscreener.com

In a Tweet, French MP Jerome Riveiere, the Chair of the French Delegation at the ID group stated France would soon have to submit to the EU. He said: In Germany, all political parties form a coalition with the common denominator of submission to the liberal and non-national EU. He added: Our country will be the first victim. Europe of nations, quickly!

The MPs rhetoric strongly condemned the supranational power of the EU, imploring that the European Union becomes separate sovereign state's to save themselves.

Germany has remained a relatively silent voice since the elections which saw Angela Merkel end her 16 years in power.

With Olaf Scholz about to head a three-party coalition with broad plans for Germany's transition to a green economy, Berlins voice is back on the stage.

The so-called traffic-light coalition is expected to highly favour the European Union model, in particular surrounding green policies, and is something that sends shivers down the spines of a nuclear ambitious France.

With the UK having left the EU, ripples of discontent at the bloc are starting to make waves across Europe, with certain French influencers floating the notion of Frexit.

Paris has enjoyed the caretaker role of EU leader since Ms Merkel stepped out of the limelight following the defeat of her part in the elections.

However, with the Germans emerging once again, a shift in the political nexus of the EU is expected.

Frances only saving grace in the matter is the upcoming Presidency of the bloc by France in the New Year.

READ MORE:German economy on brink as Merkel's successor confirmed

Germany will be looking to set the tone when it comes to green policies under the new coalition.

It will be the first three-way alliance on a national level in German history and the first to put tackling the climate emergency, which will be a priority in each of the ministries, at the top of its agenda.

As part of the goal for Germany to become climate neutral by 2045, the parties have agreed to commit to phasing out coal by 2030, outlaw combustion engines in principle, and end gas power generation by 2040.

Renewable energies are to be expanded considerably, to cover 80 percent of all energy needs by 2030.

But the governments most immediate challenge will be to control Germanys worst wave of Covid-19 since the pandemic began, especially increasing vaccinations.

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Mr Scholz said he would establish a crisis management team reporting to his chancellery, to be made up of virologists, epidemiologists, psychologists and sociologists, to advise on a way out of the emergency.

He said 1bn would be set aside to fund bonuses for health workers.

There is much speculation as to how the three parties will cooperate, owing to their considerable differences.

The Greens have pushed for a huge investment programme to fight the climate crisis, as well as to spruce up Germanys out-of-date infrastructure.

During the election campaign, they pledged to raise taxes and loosen debt rules to free up money to cover increased spending.

For France, upcoming elections will see a rise in far-right and populist parties, with two major right-wing candidates expected to pile the pressure on Mr Macron.

With both Marine Le Pen and Eric Zemmour in the running to face off with Mr Macron next year, France will look to Germany to ascertain how a coalition might work together.

French priorities now lie at home, with a renewed surge in the Covid-19 virus likely to preoccupy the minds of the powers that be in the Elysee Palace.

Additional reporting by Maria Ortega

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Submission to EU! France fears becoming first victim of Germanys new coalition - Daily Express

The recent COP26 has highlighted the need for actionable climate change mitigation strategies. A paper published online in the journal Energies has been presented with the aim of analyzing the contribution bioenergy with carbon capture and storage (BECCS) will make to help achieve the European Unions climate targets.

Study:The Role of BECCS in Achieving Climate Neutrality in the European Union. Image Credit:DisobeyArt/Shutterstock.com

There has been much talk recently about how global society needs to move toward net-zero carbon emissions by 2050. Whilst phasing out fossil fuels in favor of renewable energy sources such as solar and wind power will play their part in reducing carbon emissions, this will not be sufficient to achieve net-zero. The world urgently needs to reach this if the worst effects of anthropogenic climate change are to be avoided.

Bioenergy with carbon capture and storage (BECCS) technology.Image Credit:Tatarewicz, I et al., Energies

Large-scale technological solutions also need to be employed to mitigate the levels of carbon dioxide currently entering the environment from industrial processes and human activities. These technologies include carbon capture and storage (CCS) and bioenergy with carbon capture and storage (BECCS) and are classified as negative emissions technologies. Other solutions include reforestation, industrial electrification, electric and hydrogen fuel cell vehicles, and green agricultural practices.

The European Green Deal Strategy has been implemented by the EU, with the aim to reduce carbon emissions by 55% compared to 1990 levels. This policy is in line with the Paris Agreement that aims to limit global temperature rises to below 2oC and ideally below 1.5oC. Another current aim, alongside this pledge to cut carbon emissions, is to increase the competitiveness of European industry and carry out a fair transition to net zero.

Negative emission technologies have been receiving focus due to their ability to remove atmospheric carbon dioxide and store it for disposal or future use. BECCS has featured in many climate stabilization strategies and is included in three out of the four IPCC Special Report illustrative pathways for mitigation targets. Negative emission technologies are geo-engineering techniques that mitigate the current energy systems impact on climate change.

During plant growth, carbon dioxide is absorbed via photosynthesis. BECCS then uses this biomass as a fuel, with the carbon dioxide produced in the process removed from the atmosphere by carbon capture technologies. This sequestered carbon dioxide is then stored underground or reused in other industrial processes.

Schematic of energy chain implemented in the MEESA model. Source: own elaboration.Image Credit:Tatarewicz, I et al., Energies

BECCS offsets emissions in sectors where they are difficult to reduce. Compared to the high prices of CO2 emission allowances, BECCS is a cost-competitive technology. As long as the emissions created by the process do not exceed the carbon dioxide photosynthesized by the biomass, there is a net reduction in atmospheric CO2. Therefore, this process offsets insufficient mitigation strategies.

Negative emission technologies such as BECCS compensate for current global warming mitigation strategies, which are regarded as inadequate and could lead to cumulative greenhouse gas emission levels higher than those set by the European Unions legislation.

To illustrate the importance of the technology to international thinking, it is central to the CCCs Net-Zero scenarios, contributing to negative carbon dioxide emissions in the range of 16-39 Mt by 2050 in the United Kingdom alone.

Understanding the feasibility of the technology to realize its potential large-scale adoption is vital, as is a deeper knowledge of its limitations and required conditions.

The paper published in Energies has elaborated on the current research in the field of BECCS, especially selected studies from the LIFE Climate CAKE PL project to create a comprehensive overview of the state of current progress. In the study, the economic, technical, and environmental feasibility of the technology was analyzed and examined.

Additionally, the potential of the technology to provide electricity and heat in power stations and combined heat and power installations in the EU was investigated. Barriers and technological solutions were discussed in the research.

The technology and its competitive factors, materials and methods used in current research, in-depth modeling assumptions, research results, comparisons with other research projects, and conclusions and limitations were presented. Furthermore, the potential large-scale implementation of BECCS technologies was explored.

Use of biomass in the considered scenarios (in PJ). Source: own calculations based on MEESA model results. Image Credit:Tatarewicz, I et al., Energies

If the EU, and by extension the world, is to meet its targets on global warming and carbon emissions, it will have to embrace CCS and negative emission technologies alongside increasing renewables in the energy mix. Keeping rising temperatures below 2oC is a monumental task, but one that must be achieved. The study published in Energies has provided significant insight into current BECCS research, limitations, and potentials for the large-scale uptake of the technology in the future.

Tatarewicz, I et al. (2021) The Role of BECCS in Achieving Climate Neutrality in the European Union [online] Energies | mdpi.com. Available at:https://www.mdpi.com/1996-1073/14/23/7842

Disclaimer: The views expressed here are those of the author expressed in their private capacity and do not necessarily represent the views of AZoM.com Limited T/A AZoNetwork the owner and operator of this website. This disclaimer forms part of the Terms and conditions of use of this website.

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The Role of BECCS in Achieving Climate Neutrality in the European Union - AZoM

BASEL, Switzerland & CAMBRIDGE, Mass. & BEIJING--(BUSINESS WIRE)--BeiGene (NASDAQ: BGNE; HKEX: 06160) announced today that the European Commission (EC) approved BRUKINSA (zanubrutinib) for the treatment of adult patients with Waldenstrms macroglobulinemia (WM) who have received at least one prior therapy or for the first-line treatment of patients unsuitable for chemo-immunotherapy. The approval is applicable to all 27 European Union (EU) member states, plus Iceland and Norway. BeiGene is working to make this new treatment option available to WM patients in the EU as quickly as possible.

BTK inhibition is an established mode of treatment for patients with WM, and the approval of BRUKINSA provides an important new option for patients with WM that may offer improved outcomes, said Prof. Christian Buske, Medical Director at the University Hospital Ulm, Germany, and a trial investigator of the ASPEN study. Patients and their physicians in the EU will soon have access to an innovative medicine that has potential to offer deep and durable responses and improved tolerability, as seen in the ASPEN trial.

The EC approval for BRUKINSA follows a positive opinion granted in September by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), based on the results of the ASPEN trial. Although the primary endpoint of statistical superiority related to deep response, very good partial response (VGPR) or better, was not met, BRUKINSA demonstrated clinical benefit with advantages in safety compared to ibrutinib.1 Read more about the positive CHMP opinion and ASPEN trial results here.

With BRUKINSA now approved in the EU, we continue to execute on our commitment of making this potentially best-in-class BTK inhibitor available for more patients around the world who may benefit, said Jane Huang, M.D., Chief Medical Officer, Haematology at BeiGene. BRUKINSA was designed to maximize BTK occupancy and minimize off-target effects and has demonstrated efficacy and advantages in safety and tolerability over ibrutinib in the ASPEN trial. We believe BRUKINSA will become the preferred treatment option among patients with WM and their physicians.

We have built a strong team in Europe that is committed to creating access to BRUKINSA for patients living with WM, said Gerwin Winter, Senior Vice President, Head of Commercial, Europe at BeiGene. This approval by the European Commission is a significant milestone for BeiGenes expansion in the region, representing another step towards BeiGenes goal of increasing access to innovative oncology medicines globally.

About Waldenstrms Macroglobulinemia

Waldenstrms macroglobulinemia (WM) is a generally indolent and relatively rare B-cell malignancy characterized by bone marrow infiltration with monoclonal immunoglobulin M (IgM) secreting lymphoplasmacytic cells. WM represents approximately one percent of all non-Hodgkins lymphomas and typically progresses slowly after diagnosis.2 The disease usually affects older adults and is primarily found in the bone marrow, although lymph nodes and the spleen may be involved.3 Throughout Europe, the estimated incidence rate of WM is approximately seven out of every one million men and four out of every one million women.4

About the ASPEN trial

The Phase 3 randomized, open-label, multicentre ASPEN clinical trial (NCT03053440) evaluated BRUKINSA (zanubrutinib) versus ibrutinib in patients with relapsed or refractory (R/R) WM or treatment-nave (TN) WM considered unsuitable for treatment with chemoimmunotherapy. The primary objective was to establish superiority of BRUKINSA compared to ibrutinib as demonstrated by the proportion of patients achieving complete response or very good partial response. Secondary endpoints included major response rate (MRR), duration of response (DoR) and progression-free survival (PFS), and safety, measured by incidence, timing and severity of treatment-emergent adverse events. The pre-specified analysis populations for the trial included the overall population (n=201), of which the majority were R/R patients (n=164). Exploratory endpoints included quality of life measures.

As assessed by an independent review committee (IRC) based on the modified Sixth International Workshop on Waldenstrms Macroglobulinemia (IWWM-6) response criteria (Treon 2015), the combined rate of complete response (CR) and VGPR in the overall intention-to-treat (ITT) population was 28% with BRUKINSA (95% CI: 20, 38), compared to 19% with ibrutinib (95% CI: 12, 28). While this difference was not statistically significant, BRUKINSA did achieve numerically higher VGPR rates and trends towards increased response quality.1

In the ASPEN trial, BRUKINSA demonstrated a more favorable safety profile compared to ibrutinib with lower frequency of adverse reactions that have raised concern with BTK inhibitors, including atrial fibrillation or flutter (2% vs. 15%), minor bleeding (49% vs. 59%) and major hemorrhage (6% vs. 9%). Despite higher rates of grade 3 neutropenia, patients on BRUKINSA did not demonstrate higher rates of infection as compared to those receiving ibrutinib. Of the 101 patients with WM treated with BRUKINSA, 4% of patients discontinued due to adverse events, and adverse events leading to dose reduction occurred in 14% of patients.1

The study includes three arms in two cohorts, a randomized cohort (Cohort 1, N=201) consisting of patients with a MYD88 mutation (MYD88MUT) and a non-randomized cohort (Cohort 2, N=28) in which patients with MYD88 wild-type (MYD88WT) received BRUKINSA because historic data indicated they were unlikely to benefit from ibrutinib. The randomized Cohort 1 enrolled 102 patients (including 83 R/R patients and 19 TN patients) in the BRUKINSA arm and 99 patients (including 81 R/R patients and 18 TN patients) in the ibrutinib arm. Patients in the BRUKINSA arm were assigned to receive BRUKINSA 160 mg twice daily (BID) and patients in the ibrutinib arm received 420 mg of ibrutinib once daily (QD).

About BRUKINSA

BRUKINSA (zanubrutinib) is a small molecule inhibitor of Brutons tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.

BRUKINSA is now approved in the United States, China, the European Union and nine other countries and regions. To date, more than 20 marketing authorization applications have been submitted for BRUKINSA for various indications.

Safety Information

The most commonly occurring adverse reactions (20%) were neutropenia (56.2%), thrombocytopenia (45.1%), upper respiratory tract infection (44.3%), hemorrhage/hematoma (32.2%), rash (29.8%), bruising (29.1%), anemia (28.9%), musculoskeletal pain (24.3%), diarrhea (23.6%), pneumonia (22.1%) and cough (21.7%).

The most common Grade 3 or higher adverse reactions (>5%) were neutropenia (28.0%), pneumonia (11.6%), thrombocytopenia (11.4%), and anemia (6.9%).

Of the 779 patients treated with zanubrutinib, 3.6% of patients discontinued treatment due to adverse reactions. The most frequent adverse reaction leading to treatment discontinuation was pneumonia (1.8%). Adverse reaction leading to dose reduction occurred in 4.9% of patients.

The recommended total daily dose of zanubrutinib is 320 mg. The daily dose may be taken either once daily (four 80 mg capsules) or divided into two doses of 160 mg twice daily (two 80 mg capsules).

BeiGene Oncology

BeiGene is committed to advancing best and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. We have a growing R&D team of approximately 2,750 colleagues dedicated to advancing more than 90 ongoing or planned clinical trials involving more than 14,000 patients and healthy volunteers. Our expansive portfolio is directed predominantly by our internal colleagues supporting clinical trials in more than 45 countries and regions. Haematology-oncology and solid tumour targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development. BeiGene currently has three approved medicines discovered and developed in our own labs: BTK inhibitor BRUKINSA in the United States, China, the EU, Canada, Australia, and additional international markets; and the non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab as well as the PARP inhibitor pamiparib in China.

BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen and Bristol Myers Squibb. We also plan to address greater areas of unmet need globally through our collaborations including with Amgen, Bio-Thera, EUSA Pharma, Mirati Therapeutics, Seagen, and Zymeworks. BeiGene has also entered into a collaboration with Novartis granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.

About BeiGene

BeiGene is a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide. With a broad portfolio of more than 40 clinical candidates, we are expediting development of our diverse pipeline of novel therapeutics through our own capabilities and collaborations. We are committed to radically improving access to medicines for two billion more people by 2030. BeiGene has a growing global team of over 7,700 colleagues across five continents. To learn more about BeiGene, please visit http://www.beigene.com and follow us on Twitter at @BeiGeneGlobal.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the planned commercialization and market access of BRUKINSA in the European Union and additional development, regulatory filings and potential approvals in other markets, the potential for BRUKINSA to be a best-in-class BTK inhibitor, the potential for BRUKINSA to provide improved clinical benefits with advantages in safety, the potential for BRUKINSA to become the preferred treatment option among patients with WM and their physicians, the potential commercial opportunity for BRUKINSA, and BeiGenes plans, commitments, aspirations and goals under the headings BeiGene Oncology and About BeiGene. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene's ability to achieve commercial success for its marketed products and drug candidates, if approved; BeiGene's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeiGene's reliance on third parties to conduct drug development, manufacturing and other services; BeiGenes limited operating history and BeiGene's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; the impact of the COVID-19 pandemic on the Companys clinical development, commercial and other operations, as well as those risks more fully discussed in the section entitled Risk Factors in BeiGenes most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.

* BRUKINSA is approved in the following indications and regions:

a. This indication was approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

b. This indication was approved under conditional approval. Complete approval for this indication may be contingent upon results from ongoing randomized, controlled confirmatory clinical trials.

References:

1. Tam, et al. A randomized phase 3 trial of zanubrutinib vs ibrutinib in symptomatic Waldenstrm macroglobulinemia: the ASPEN study. Blood. October 2020. 136(18): 2038-2050.

2. Lymphoma Research Foundation. Getting the Facts: Waldenstrm Macroglobulinemia. Available at https://lymphoma.org/wp-content/uploads/2020/09/LRF-Waldenstrom-Macroglobulinemia_Factsheet.pdf. Updated 2020.

3. Lymphoma Research Foundation. Available at https://lymphoma.org/aboutlymphoma/nhl/wm/. Accessed December 2020.

4. Buske, C, et al. Treatment and outcome patterns in European patients with Waldenstrms macroglobulinaemia: a large, observational, retrospective chart review. The Lancet Haematology 2018; 5: e0299-309.

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BeiGene Announces Approval of BRUKINSA (zanubrutinib) in the European Union for Treatment of Adults with Waldenstrm's Macroglobulinemia - Business...