Mediaboss Marketing

On Monday, the European Union (EU) gave official permission for the "conditional marketing authorization" of the first-ever Ebola vaccine. A pharmaceutical company, Merck, is developing the vaccine known as 'Ervebo.'

Ervebo has been approved for "individuals aged 18 years and older" and has already been used in critical situations with emergency guidelines in the Democratic Republic of Congo (DRC).

RELATED: NEW EBOLA DRUG BREAKTHROUGH HAS PROMISING '90% SURVIVAL RATE'

The vaccine 'Ervebo' was first developed by the Public Health Agency of Canada and the U.S. Army approximately ten years ago. It was in 2014 that Merck bought the rights to develop the vaccine, following the Ebola outbreak in West Africa.

The E.U.'s "conditional marketing authorization" is an approval exclusively for medicine that focuses on unmet medical needs, such as Ebola.

It permits the development of medicine to move forward with less comprehensive data than is usually required, only if the benefits outweigh the risks.

Ervebo has been 100% effective during its trials in Guinea, and Merck has already offered over 250,000 doses to the World Health Organization (WHO).

Even though this news is incredibly promising, patience is still required. Merck's plan is to start manufacturing the vaccine in Germany in2020, at the start of the third quarter.

In the U.S., the Food and Drug Administration (FDA) still has the vaccine under "priority review," with an answer expected next year.

The decision by the E.U. is indeed a promising one, especially given the European Commission's records that state over 11,000 people have died in West Africa since the outbreak began in 2014.

The DRC has shown a 67% fatality rate once people contract the virus, andbetween August 2018 and October 2019, there were over 3,000 confirmed cases of the virus and 2,123 documented deaths.

The Ebola crisis is not over yet and is still considered an international public health emergency.

View original post here:
Ebola Vaccine Approved for the First Time Ever by the European Union - Interesting Engineering

Greece offered words of encouragement toNorth Macedonia and Albania on Thursday as the two countries' efforts to open accession talks with the European Union continueto be frustrated.

Greek Prime Minister Kyriakos Mitsotakis said that "despite reservations'' the EU is "keeping its doors open.''

Mitsotakis said Greece wants both its neighbors in the EU and saidtheir efforts will come to fruition "at some point.''

Still hoping for a U-turn

Last month French President Emmanuel Macron led a small group of EU leaders who blocked accession talks.

"We are disappointed," North Macedonia's Prime Minister Zoran Zaev said after meeting Mitsotakis on the sidelines of an economic forumin Thessaloniki in northern Greece.

Zaev said he had received "huge encouragement" from his Greek counterpart adding that "there is no alternative for us,"referring to North Macedonia's EU aspirations.

Both North Macedonia and Albania areEU candidate countries. However, even when accession talks begin, it can still take several years before officially joining the bloc. Negotiations withthe EU's most recently installed member state, Croatia, lasted eight years.

As well as Greece and North Macedonia, the geographic region of Macedonia extends into Albania, Bulgaria and Serbia as well as small areas of Kosovo (which you can't quite see here).

The ancient kingdom of Macedonia or Macedon was a relatively small part of the present day Greek province of Macedonia. It first expanded under King Perdiccas I, then widened to take in other areas.

After the fall of the Greek Empire, the Romans who admired Alexander used the old name Macedonia for the province encompassing much of northern Greece and the area north of it including much of the modern-day North Macedonia.

With the breakup of the Roman Empire into East and West, this region was overrun by the Slavic invasions. An entirely new province far to the east, including part of Thrace in modern-day Turkey, was named Macedonia by the Byzantine Empress Irene of Athens.

The geographic region known as Macedonia today roughly equates to the part of the Ottoman Empire known as Ottoman Vardar Macedonia. It included Greek and Slavic areas and was split into three administrative units, but the concept of Macedonia persisted. This remained the case for centuries and so this concept of what Macedonia is has stuck.

...and there's certainly a fair bit of overlap and room for confusion.

Of course, Macedonia's King Alexander the Great's realm stretched all the way to India but it would be a bit of a stretch to call that Macedonia

As if it werent complicated enough, theres another meaning of the word Macedonia. In Greece and many Latin-language-speaking countries, its also a fruit salad. The name is thought to have ben popularized at the end of the 18th century, referring to either the ethnic diversity of Alexander's vast empire or the ethnic mix of Ottoman Macedonia.

Author: Richard Connor

jsi/rt(AP, Reuters)

Each evening at 1830 UTC, DW's editors send out a selection of theday's hard news and quality feature journalism. You can sign up toreceive it directly here.

Visit link:
Greece backs EU ambitions of North Macedonia and Albania - DW (English)

Michael Gove has been criticised for talking nonsense after blaming the EU for the British government missing its target on planting trees.

The former environment secretaryscomments came during an interview on Radio 4s Today programme in which he insisted the Conservatives were dedicated to meetingthe challenge of the climate emergency.

Pushed on the fact that the government was set to fail to deliver on the 2015 Tory manifesto promise to plant another 11 million trees by 2020, Mr Gove said: And thats why we need to leave the European Union.

Sharing the full story, not just the headlines

He added: Inside the European Union were trapped in the Common Agricultural Policy. Its one of the big benefits of leaving the European Union, and it will allow us to meet these tree-planting targets which will ensure that we deal with the climate crisis that we face.

Environmental groups warn expandingforest cover is vital if Britain is to meet climate targets and protect wildlife and have urged the government to implement legally binding targetsin the new Environment Bill.

The government has plantedjust a third of the trees it promised in 2015 and campaigners say ministersfailed to implement policy to increase that rate.

The Independent / Getty

The Independent / Getty

The Independent / Getty

Getty

The Independent / Getty

The Independent / Getty

The Independent / Getty

The Independent / Getty

The Independent / Getty

Getty

The Independent / Getty

The Independent / Getty

The Conservatives claim farmers would be given more support for tree-planting if the UK was no longer beholden to the EUs Common Agricultural Policy (CAP.)

But Guy Shrubsole, a trees campaigner at Friends of the Earth, said: Blaming the EU for successive UK governments failure to plant more trees is nonsense given that the UK has 13 per cent woodland cover, when the EU average is 37 per cent.

Dr Doug Parr, chief scientist for Greenpeace UK,added: Michael Gove is barking up the wrong tree and knows it.

EU farming policies can be blamed for many things but not for the governments failure to plant more trees. The UK has less forest cover than most countries under the CAP.

Successive Conservative governments have already ensured we will miss one tree-planting target in 2020, and were on track to miss the one in 2022. Now theyve set themselves a new target for 2025 and people will be wondering whether this is raising the ambition or just moving the goalposts yet again.

Liberal Democrat MP Tom Brake also criticised MrGove, telling Sky News: Im not aware that theres anything that the EU could do if they wanted to to stop us planting trees.

Parties across the political spectrum have been boasting about the tree-planting efforts they would undertake if they won the general election. The Conservatives said they will triple planting rates while the Liberal Democrats promised they will plant twice as many trees as the Tories.

Boris Johnson has announced a 640m Nature for Climate fund which would increase tree-planting in England, with the government aiming to work with the devolved administrations to boost tree-planting rates to 30,000 hectares every year. The Conservatives said this could mean 30 million more trees.

The Lib Dems said they would plant 60 million trees every year if elected, describing their proposals as the largest tree-planting programme in UK history, while pointing out that the Tories have woefully failed to meet their own targets for planting trees in the past year.

Labour also said the Conservatives hadfailed to meet previous tree-planting targets and said Mr Johnson was attempting to greenwash his atrocious environmental record.

Under the Tory plans, new forests would spring up and existing woodland such as the Northern Forest and Northumberland Forest would be expanded, while more trees would also be planted in towns and cities.

The fund would also be used to restore degraded peatland across the country, the party said.

Support free-thinking journalism and attend Independent events

Mr Johnson said: There is nothing more conservative than protecting our environment and these measures sit alongside our world-leading commitment to net-zero greenhouse gas emissions by 2050.

But, just as with our planned investment in schools and hospitals, we can only do any of this if we end the gridlock and deadlock in parliament with a Conservative-majority government.

Lib Dem leader Jo Swinson said: Its clear that the Conservative Party doesnt take climate change seriously.

Only the Liberal Democrats have a radical plan to make a real impact in the fight against climate change and build a brighter future for our planet.

Sue Hayman, shadow environment secretary, said: When Labour comes forward with its own ambitious proposals as part of our Plan For Nature, they will be informed by what the science says is necessary and possible not by what Boris Johnson thinks he needs to do to greenwash his atrocious environmental record.

Read more here:
Its nonsense: Michael Gove criticised after blaming EU for government missing tree-planting target - The Independent

Aquestive Therapeutics has granted a development and commercialization license to Zambon Pharma forits investigational oral film formulation of riluzoleas a treatment for amyotrophic lateral sclerosis (ALS) in the European Union (EU).

Under the terms of the agreement, Zambon will be responsible for the regulatory approval and marketing of the new formulation in the EU, and Aquestive will be responsible for manufacturing the product.

Zambon will pay Aquestive an undisclosed sum for the rights of commercialization, as well as specified milestone payments, and royalties on the net sales of the therapy.

We are pleased to announce our collaboration with Zambon to develop and commercialize [rulizole oral film] in the European Union, Keith J. Kendall, CEO of Aquestive, said in a press release.

Thanks to this collaboration with Aquestive, Zambon will further strengthen its commitment to orphan diseases and the [central nervous system] area, enriching its portfolio with a new formulation that will concretely help patients. Zambon is committed to improving peoples quality of life through innovative medicines and modern therapeutic solutions where they are most needed, said Roberto Tascione, CEO of Zambon.

The oral film formulation of riluzole consists of strips that dissolve when placed over the tongue without the need for water.It uses Aquestives PharmFilm technology, which combines permeation enhancers, stabilizers, and polymer blends to ensure steady delivery of the therapy throughout the lining of the mouth.

Riluzole oral film was designed to facilitate intake of medications by ALS patients who have difficulty swallowing.

The U.S. Food and Drug Administration (FDA) is currently reviewing the new drug application of riluzole oral film, under the brand name Exservan. A decision as to whether the formulation will be approved for sale is expected Nov. 30.

Once approved, we believe that riluzole, via our orally administered dosage form, can bring meaningful and positive change for the care of patients who are diagnosed with ALS and face difficulties swallowing or administering traditional forms of medication, Kendall said.

Previous patient studies showed that riluzole oral film can be taken safely twice a day and that it has a pharmacokinetics profile absorption, availability, distribution, metabolism, and elimination by the body equivalent to that of the capsule formulation, Rilutek.

Riluzole was the first treatment approved to treat ALS. It belongs to a class of medications called benzothiazoles and acts by changing the activity of natural substances produced by the body that can damage nerve cells. In ALS, the treatment slows symptomprogression and prolongs survival.

This compound is currently approved under two formulation, as tablets, under the brand name Rilutek, and as an oral liquid solution, under the brand name Tiglutik.

Alejandra has a PhD in Genetics from So Paulo State University (UNESP) and is currently working as a scientific writer, editor, and translator. As a writer for BioNews, she is fulfilling her passion for making scientific data easily available and understandable to the general public. Aside from her work with BioNews, she also works as a language editor for non-English speaking authors and is an author of science books for kids.

Total Posts: 5

Ins Martins holds a BSc in Cell and Molecular Biology from Universidade Nova de Lisboa and is currently finishing her PhD in Biomedical Sciences at Universidade de Lisboa. Her work has been focused on blood vessels and their role in both hematopoiesis and cancer development.

See the original post:
Aquestive Licenses ALS Therapy Riluzole Oral Film to Zambon in the EU - ALS News Today

At a Berlin conference to prepare for the UNs annual climate summit (COP25), Environment Minister Svenja Schulze and Foreign Minister Heiko Maas stressed the EUs responsibility in closing the Paris Climate Agreements remaining gaps, particularly by raising the targets at the EU level. EURACTIV Germany reports.

About two weeks before COP25 in Madrid, two MPs from the Socialist Democratic Party (SPD) called on the EU to take on a leadership role at the annual conference. It should close the remaining gaps in the Paris climate agreement, they said.

Europe must play a leading role in climate ambitions. As major emitters, we must send the right signals, Foreign Minister Heiko Maas said on Thursday (14 November). Alluding to the US, he added that in times of national unilateralism, the international community cannot rely on the COP process alone.

It is therefore crucial for the EU to engage in dialogue with other progressive forces and sharpen its goals.

UPDATE: The European Commission warned EU countries today (18 June) that draft national plans for the coming decade are insufficient to achieve the blocs 2030 energy and climate targets. Substantial gaps have been identified on renewables and energy efficiency.

The European Union must do more. We cannot stick to the current climate ambitions we have set, Environment Minister Schulze added. She would support Ursula von der Leyens ambitions for increased climate protection.

Regarding her expectations for COP25, Schulze said she hoped an agreement would be reached on an international credit system for emission certificates that would function without loopholes and without double counting, one of the open negotiating points that should be concluded in Madrid.

Article 6 of the Paris agreement the market mechanism

Article 6 provides for an international regulation which deals with the trading of pollution rights, similar to the EU Emissions Trading Scheme (ETS). Up to now, states have been able to finance environmental measures in other countries under the Kyoto Protocol adopted in 1997 and have offset such carbon savings against their national carbon footprints.

However, the international agreement expires in 2020 and is to be replaced by provisions laid out in the Paris Agreement. It is still unclear according to which rules emissions trading should take place and whether countries will be allowed to finance climate measures abroad and count them as their emission reductions in the future.

It also remains to be seen whether countries will be able to continue to take into consideration their achievements made under the Kyoto Protocol after 2020, once the Paris Agreement comes into effect. While Brazil, China and India have so far argued in favour, critics have warned against greenwashing.

The main objective of the negotiations will be to convince Brazil.

Damage and losses the Warsaw mechanism

The so-called Warsaw mechanism, which provides for financial and technical assistance to regions affected by climate change, will be reviewed and adapted in Madrid. Its primary instrument is the international Green Climate Fund, which currently has $5.6 billion at its disposal.

From 2020, the money pot is to be significantly increased to $100 billion a year. But it is still unclear where the funds will come from, even though many countries have already pledged to raise their funds.

It is also still unclear how losses will be quantified and compensated internationally, and to what extent which countries will be held responsible.

Data collection

At the climate summit, the international community will continue to work on a uniform basis for a global reporting mechanism to report that monitors environmental measures.

At last years COP24, it was possible to draw up uniform guidelines for comparing the national climate contributions of all countries. Bureaucratic regulations for reporting now have to be agreed upon.

The COP25s central objective will also be to persuade the international community to raise its climate targets, which, according to the Paris agreement, should happen every five years. The climate plans presented so far are not sufficient to keep global warming below two degrees, but would instead lead to a three-degree scenario.

In a UN assessment published on 21 September, it was concluded that G20 nations are collectively not on track to meet their Paris Agreement commitments.

At the UN climate summit in New York in September, around 60 countries, therefore, promised to adjust their climate targets accordingly next year.

The European Commission also warned member states in June that their submitted climate plans were inadequate.

The incoming Commission President Ursula von der Leyen is therefore calling for an increase in the EU target for the reduction of greenhouse gas emissions from 40% to 55%, compared to 1990 levels. This is also in line with a demand by the European Parliaments Environment Committee (ENVI).

In a COP25 resolution adopted last week, MEPs called for a minimum increase of 55% and recommended that shipping and air transport be integrated into national climate plans.

Officially, the COP25 will be the last opportunity for all member states to adapt their national climate plans in time, as they must be submitted nine to 12 months before the following COP26 in November 2020.

[Edited by Zoran Radosavljevic]

Continue reading here:
German ministers urge EU to lead the way at COP25 in Madrid - EURACTIV