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This approval makes the drug the first and only targeted medicine indicated to treat this population of children in Europe and the United States.

The European Commission (EC) has approved Dupixent (dupilumab) in the European Union to treat severe atopic dermatitis in children six months of age to five years of age who are candidates for systemic therapy. This approval makes the drug the first and only targeted medicine indicated to treat this population of children in Europe and the United States.

Dupixent is a subcutaneous injection at different injection sites and is intended for use under the guidance of a healthcare professional. It can be given in a clinic or at home by self-administration after training by a healthcare professional.

The approval is based on data from a Phase III trial that evaluates Dupixent every four weeks plus low-potency primarily topical corticosteroids (TCS) or TCS alone in 162 children between six months of age to five years of age with moderate-to-severe atopic dermatitis. The medicine improved skin clearance and reduced overall disease severity and itch at 16 weeks compared to placebo in the overall enrolled population.

In addition, Dupixent improved sleep quality, skin pain, and health-related quality of life compared to placebo in both the overall and severe populations, and the long-term efficacy data showed the clinical benefit at 16 weeks was sustained through 52 weeks, according to the Sanofi.

Common side effects across all indications include injection site reactions, conjunctivitis allergic, arthralgia, oral herpes, and eosinophilia.

Source: Sanofi

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European Commission Approves Dupixent as First, Only Targeted ... - BioPharm International

EMA has published a report summarising the mid-term achievements of itsRegulatory Science Strategy (RSS) to 2025. The report provides an overview of the main deliverables achieved between March 2020 and December 2022 across the human and veterinary areas.

The achievements highlighted in this report demonstrate that we have made considerable progress in advancing regulatory science to build a more adaptive regulatory system that encourages innovation in human and veterinary medicines, said Emer Cooke, EMAs Executive Director.

The mid-term report highlights achievements for the top five human and top three veterinary recommendations thought to deliver the most significant change over the course of the five-year strategy, according to an extensive stakeholder consultation process that took place with EMAs scientific committees, stakeholders and EU regulatory partners.

In thehumandomain, progress was made in several areas, including:

In theveterinarydomain, progress was made in several areas, including:

The report also highlights achievements for thehumanandveterinary medicines strategies. Links are included in the report to detailed information on goals, core recommendations and underlying actions in these areas.

Work will continue at pace through 2023-2025 to deliver the strategic goals to their fullest potential.

We will seek opportunities to further progress delivery of the Regulatory Science Strategy to 2025, and the broaderEuropean medicines agencies network strategy to 2025, as we emerge from a long period of business continuity. This work will be crucial to evolve the networks capability to engage with and enable innovative science and technology within the current pharmaceutical framework and pave the way for the legislative review, added Ms Cooke.

A final report on the regulatory science strategy will be published in 2026, once the strategy has been completed.

EMA published its Regulatory Science Strategy to 2025 in March 2020. The strategy was developed in 2018 and 2019 in consultation with a wide range of stakeholders and provides a plan for advancing regulatory science over a five-year period.

The motivation behind the strategy was the recognition that the pace of innovation had accelerated dramatically in recent years. As part of their mission to promote and protect human and animal health, regulators needed to be ready to support the development and assessment of ever more complex medicines that increasingly deliver healthcare solutions by converging different technologies.

Furthermore, the advent ofBig data opened up new sources of information on the use of medicines in healthcare settings. Regulators needed to take action to address the challenges arising from collecting and processing these data from patients.

The COVID-19 pandemic also underlined the need for rapid and close engagement of all stakeholders and partners involved in the development and supervision of medicines in the European Union and globally, which is one of the fundamental principles of this strategy.

Note

Regulatory sciencerefers to the range of scientific disciplines that are applied to the quality, safety and efficacyassessment of medicinal productsand that inform regulatory decision-making throughout the lifecycle of a medicine. It encompasses basic and applied biomedical and social sciences and contributes to the development of regulatory standards and tools.

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Advancing regulatory science in the EU mid-point report published ... - European Medicines Agency |

MEPs Alex Agius Saliba and David Casa have protested about a lack of translators of Maltese at European Union meetings, insisting that the situation is unacceptable.

Agius Saliba said the latest case happened on Wednesday at a meeting of the European Parliament's employment committee on the subject of discrimination. Soon after he started to speak, in Maltese, he was cut off and told by an official that an interpreter was not available.

Agius Saliba obliged, but not before delivering a stern rebuttal to colleagues in the committee.

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This is happening continuously in this committee we have been complaining about this for a number of weeks now, he said.

Branding the lack of interpreters as discrimination against the Maltese language, Agius Saliba told officials he would continue in English, but would not be so accommodating in the future.

[It is] totally unacceptable I cannot speak as my colleagues do in an official language of the European Union today I will be making my intervention, but Im sorry, next time he said.

Agius Saliba noted that there were other Maltese representatives present for the meeting, including the EUs Commissioner for Equality Helena Dalli.

Fellow MEP David Casa (PN) joined Agius Saliba in denouncing the lack of interpretation at the committee meeting.

It is not acceptable that my colleague was unable to speak in Maltese during the hearing in committee, he said.

Casa agreed that Maltese interpretation should be available and said he had written to the EU about the issue.

The Maltese language is an official language of the European Union, just as French or German or Slovak or Greek. Maltese interpretation should be available in such meetings, Casa said.

As an official language of the EU, Maltese is meant to be accepted and interpreted in all official meetings. With 22 commission meetings taking place, often at the same time, however, a lack of interpreters can mean that not all 24 official languages are always able to be interpreted, an MEP told Times of Malta.

This was not the first time that the EU has come under fire for not providing sufficient interpretation services in Maltese.

In 2020, Labour MEP Alfred Sant complained that many freelance interpreters had been left out in the cold during the COVID-19 pandemic due to meetings taking place virtually, branding the lack of personnel manifestly unfair and unjust.

In 2005, former Labour MEP and later Prime Minister Joseph Muscat refused to continue addressing the European Parliament (EP) after he was informed no interpreters were present to translate his speech from the Maltese language.

This situation is not acceptable anymore. We either have our language as an official one with all its full rights or we have only an official language on paper, Muscat told the EP back in 2005.

According to the EUs language policy as found on the EP website, the EU has adopted a full multilingual language policy, meaning that all EU languages are equally important... every Member of the European Parliament has the right to speak in the language of his or her choice.

Independent journalism costs money. Support Times of Malta for the price of a coffee.

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Lack of Maltese interpreters in the EU 'totally unacceptable,' MEPs ... - Times of Malta

23 March 2023

Bergeson & Campbell

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On February 28, 2023, the European Chemicals Agency (ECHA) announced that it updated its recommendationsto improve Registration, Evaluation, Authorisation and Restrictionof Chemicals (REACH) registrations. According to ECHA, therecommendations are based on ECHA's findings from registrationdossier compliance checks and take recent changes to REACHinformation requirements into account. The recommendations focus onthe rules for using adaptations to assess the safety of chemicalswithout animal testing. ECHA states that they provide advice onread-across, covering considerations on structural similarity,defining substance groups, and predicting target substanceproperties. ECHA also provided information on adaptations based onexposure scenarios outlined in chemical safety reports. Accordingto ECHA, further advice addresses the requirements for mutagenicityinformation and chronic aquatic toxicity studies for poorly solublesubstances. ECHA recommends that companies review therecommendations to make sure their dossiers comply with REACH andensure the safe use of their chemicals.

ECHA also released statistics on its progress evaluatingregistered substances. In 2022, ECHA conducted 330 compliancechecks covering more than 2,300 registration dossiers andaddressing 295 substances. According to ECHA, 302 checks were fullcompliance checks, addressing all relevant endpoints of substancesof potential concern. They resulted in 277 draft decisions beingsent to companies, requesting more data to clarify long-termeffects on human health or the environment. ECHA adopted 252compliance check decisions together with European Union (EU) memberstates. ECHA states that these decisions addressed data gapsremaining after draft decisions and dossier updates. ECHA alsoadopted 169 testing proposal decisions addressing 347 informationrequirements for which testing was originally proposed byindustry.

ECHA follows up on information requests sent to companies tocheck whether the information provided by companies complies withREACH requirements. According to ECHA, in 2022, this was concludedfor 249 substances. In about 60 percent of the cases, companiesprovided the requested information. ECHA notified the remaining 40percent to EU member states for enforcement. ECHA notes that italso adopted nine substance evaluation decisions, requestingfurther information to assess the safety of substances of potentialconcern.

The content of this article is intended to provide a generalguide to the subject matter. Specialist advice should be soughtabout your specific circumstances.

POPULAR ARTICLES ON: Energy and Natural Resources from European Union

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ECHA Updates Recommendations To Improve REACH ... - Mondaq News Alerts

A unified organization of 27 member countries, with authority over their political, economic, and social policies

The European Union (EU) is a unified international organization that governs the economic, political, and social policies of 27 member states. Originally formed with the desire to achieve peace in Europe, current EU policies are tailored to ensure the free movement of people, goods, services, and capital among its member states.

The European Union was built with the aim of ending frequent wars among neighboring countries following the Second World War. In 1951, the European Coal and Steel Community (ECSC) started uniting nations to achieve peace.

The six founding countries of the EU are:

The Treaty of Rome was signed in 1957, creating the European Economic Community, or a common market. It was followed by a period of economic growth a result of lowering trade restrictions among member states.

The EU experienced continued expansion ever since, with the fall of communism and the Berlin Wall supporting a closer-knit Europe. In 1993, the Single Market agreement was completed, allowing four types of freedoms the movement of goods, services, people, and money.

As more members joined the EU, it grew from a community of six member states to 27 member states.

To be a part of the EU, applicant countries must meet certain conditions, known as the Copenhagen criteria. The key criteria are listed below:

Following the exit of the United Kingdom in early 2020, there are now 27 remaining member states of the EU.

The European Union oversees three main institutions that are involved in legislation:

The European Parliament is elected by the EUs citizens and is responsible for law-making, supervision, and budget establishment.

Represents the governments of each of the EUs member states, with one minister from each state. Responsible for coordinating policies, adopting EU laws, and voicing the opinion of member states.

The EUs politically independent executive arm, responsible for proposing and enforcing legislation, managing policies, allocating budgets, and representing the EU internationally.

The EU is the largest trading power and the largest single-market area in the world. In 2019, the EU posted a GDP of $15.59 trillion, only behind the United States in terms of economic size.

Free trade within the EU was one of the unions foundational rules. Trade among member states is completely free, allowing the exchange of goods and services across borders without any tariffs or quotas.

Besides free trade among member states, the EU also promotes the concept of open economies in foreign trade. The EU also signed several trade agreements with a number of countries, including:

With each trade agreement, the EU aims to either cut or remove tariffs, making the cross-border flow of goods and services easier for exporters and importers.

The EUs top 10 trading partners:

In 2019, the EUs five largest exports were:

The EUs five biggest imports were:

In addition, countries in the EU are the largest importers of cocoa beans, which explains the Netherlands and Germanys prowess in the chocolate industry and the high per-capita chocolate consumption across Europe.

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European Union - Overview, History, Membership, Insitutions