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EMA has opened a public consultation to review the transparency rules for the publication of information on clinical trials submitted through theClinical Trials Information System(CTIS) in the European Union (EU). Stakeholders are invited to send their comments via an online form by midnight (CET) on 28 June 2023.

The review of the CTIS transparency rules seeks to stimulate the discussion on the best possible approaches to balance clinical trial transparency with confidentiality requirements while simplifying the modalities of use of CTIS to improve user experience and reduce the risk of data breaches. Any changes in the CTIS functionalities that might be required following the public consultation will maintain the high benchmark for transparency provided by theClinical Trials Regulation (CTR). The simplification of the rules is meant to reduce administrative burden for public authorities and sponsors of CTIS, but they will not entail decreased protection of personal data and commercially confidential information. Following the public consultation, any revision to the transparency rules will be presented to EMAs Management Board for approval and implementation before the end of 2023.

Interim guidance on the protection of personal data and commercially confidential information while using the current transparency rules for CTIS has been modified following public consultation and is available to assist clinical trial sponsors and authorities in fulfilling the obligations set out in the CTR. Finalisation of this guidance based on the current transparency rules is expected in the third quarter of 2023.

The CTR strengthens Europe as an attractive location for clinical research, by streamlining the processes for applying for authorisation and supervision of clinical trials, no matter where clinical trial sponsors are located and which national competent authority or national ethics committee they are dealing with.

The streamlined processes introduced by the Regulation are enabled by the CTIS, the single entry point for the submission and assessment of applications for clinical trials for sponsors and regulators. The system includes a public searchable database for healthcare professionals, patients and the general public to deliver the high level of transparency foreseen by the regulation.

The authorisation and oversight of clinical trials is the responsibility of EU / European Economic Area (EEA) Member States while EMA is responsible for maintaining the CTIS. The European Commission oversees the implementation of the CTR.

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Review of transparency rules for the EU Clinical Trials Information ... - European Medicines Agency |

On 4 May 2023, Egypt and the European Union co-chaired the 21st Global Counterterrorism Forum (GCTF) Coordination Committee Meeting, under the auspices of Sameh Shoukry, Minister of Foreign Affairs of Egypt, in Cairo. Over 150 senior officials and practitioners from more than thirty countries discussed future action to counter global terrorism threats. At the meeting, co-chairs Egypt and the European Union presented their vision for the strategic direction and objectives of the GCTF during their tenure (2023-2025). Central to this vision is a more action-oriented and responsive Forum, delivering value where it is most needed.

Sameh Shoukry, Minister of Foreign Affairs of Egypt, and Charles Fries, Deputy Secretary General of the European External Action Service, opened the Coordinating Committee meeting, underscoring their joint vision for a responsive approach to a developing counterterrorism landscape. In keeping with this, during the meeting, GCTF members engaged with practitioners from West Africa on the challenges facing the region and the most pressing needs to tackle the rehabilitation and social reintegration of former fighters and their family members, where the GCTF would seek to provide support.

We are honored to be hosting the first GCTF Coordinating Committee meeting co-chaired with the European Union, in which all parties underscored their collective commitment to continue fighting this global scourge. As Co-Chairs, we recognize the importance of driving global counterterrorism efforts and preventing and countering violent extremism conducive to terrorism, including through addressing the root causes of terrorism and countering terrorist narratives and ideologies. Throughout our tenure, Africa will be a key priority. We are determined, throughout our tenure, to focus our attention on new and emerging threats, said Sameh Shoukry, Minister of Foreign Affairs, Egypt.

We are in Africa today, where the threat of terrorism is rapidly evolving, with global implications. Our message is clear: we must focus on tackling the scourge of terrorism across the continent and we must do so together with a wide range of actors from the ground governments, communities, civil society. The EU is committed to assuring the GCTF is dynamic, action-oriented and remains fit-for-purpose. Africa is a strategic priority of our tenure as co-chair. We hope to engage and hear more from those directly affected and provide responses to the challenges they face. Embracing more African partners within the Forum would represent a key step in this direction. said Charles Fries, Deputy Secretary General of the European External Action Service.

During the event, Morocco formally handed over the Co-Chair to Egypt. The GCTF members expressed their gratitude to Morocco for its unstinting work over the past eight years as Co-Chair.

Over the course of three consecutive mandates, Morocco has embarked on an exciting journey as Co-Chair of the Forum to steer GCTF efforts as a crucial platform for international cooperation on counterterrorism. We are honoured for the trust and confidence bestowed upon us, as we have dedicated the best of our efforts to promoting the Forums vision. Thanks to this collective engagement, we have made remarkable strides, and achieved outstanding endeavors. Continuing this commitment, Moroccos engagement to the GCTF mission will remain unequivocal. We will spare no efforts to pursue advancing the Forums vision and goals, said Ismail Chekkori, Director of Global Issues, at the Ministry of Foreign Affairs, African Cooperation and Moroccan Expatriates of Morocco.

Co-Chairs Egypt and the European Union expressed their commitment to working with the GCTF members to implement a comprehensive and global approach that addresses the root causes of terrorism and provides adequate and operational responses to threats on the ground. They underlined the importance of a deepened engagement with other actors in so doing, whilst stressing the importance they attach to greater collaboration with the three Institutions inspired by the GCTF the Global Community Engagement and Resilience Fund (GCERF), Hedayah and the International Institute for Justice and the Rule of Law (IIJ) in delivering on GCTF priorities and the co-Chairs vision.

Background

The Global Counterterrorism Forum was established in 2011 by 30 Members as an informal, apolitical, multilateral counterterrorism platform to strengthen international efforts in the strategic, long-term approach to counterterrorism and violent extremism conducive to terrorism. It has since responded to new and emerging threats through the development of practical tools for policymakers and practitioners. The Forum collaborates with partners around the globe to identify critical civilian counterterrorism needs and to mobilize the necessary expertise and resources to support capacity building. The GCTF works closely with the UN Global Coordination Compact; GCTF policy tools and documents have been widely used by the UN system and beyond. They have also formed the basis of UN Security Council Resolutions on counterterrorism. The GCTF also works hand in hand with the GCTF-Inspired Institutions: the Global Community Engagement and Resilience Fund (GCERF) based in Geneva; Hedayah (the International Centre of Excellence for Countering Violent Extremism) based in Abu Dhabi; and the International Institute for Justice and the Rule of Law (IIJ), based in Valletta.

The GCTF Coordination Committee Meeting takes place twice each year. This was the first meeting co-hosted by Egypt and the European Union; the next will take place in September, alongside a GCTF Ministerial meeting in New York.

Website: https://www.thegctf.org/

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Counter-terrorism: Joint EU-Egypt press release following the 21st ... - EEAS

PEGylated enzyme replacement therapy designed to provide a long half-life

PARMA, Italy, BOSTON and CARMIEL, Israel, May 5, 2023 /PRNewswire/ -- Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people affected by rare diseases, and Protalix BioTherapeutics, Inc. (NYSE American:PLX), a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx, today announced that the European Commission (EC) has granted marketing authorization to PRX-102 (pegunigalsidase alfa) in the European Union (EU) for the treatment of adult patients with Fabry disease.

"People living with Fabry disease often perceive their disease as burdensome and still experience unmet medical needs," said Giacomo Chiesi, head of Chiesi Global Rare Diseases. "Our deepest gratitude to all patients and patient advocates who have stood shoulder-to-shoulder with clinical researchers, scientists and regulators during the clinical development program, providing the data needed for this approval. I believe this is a vital ingredient in bringing innovation to the real lives of patients and enabling hope and definitive, integrated solutions."

"We are delighted that the European Commission has approved PRX-102 for the treatment of adult patients with Fabry disease. The EU authorization is a testament to our commitment to deliver innovative therapies and solutions for people affected by rare diseases," said Diego Ardig, M.D., Ph.D., head of research and development of Global Rare Diseases at the Chiesi Group. "As a certified B Corp we are committed to ensuring access to PRX-102 to as many people living with Fabry disease as possible and thank those who participated in our extensive clinical research program. It is important to deliver this new treatment option to reduce the burden of this chronic disease on patients, their families, and the healthcare system."

"The European Commission's approval of PRX-102 is a significant milestone for patients with Fabry disease and their families, providing a new therapeutic option," said Dror Bashan, Protalix's President and Chief Executive Officer. "We are proud of this achievement and believe that this approval further validates our science and technology. Based on solid results from our robust clinical programs, PRX-102 has the potential to be widely used for many years to come. Together with Chiesi, we remain committed to meeting the needs of patients with Fabry disease and bringing this new treatment option to market."

PRX-102 is a PEGylated enzyme replacement therapy (ERT). It is a recombinant human GalactosidaseA enzyme expressed in plant-cell culture that is designed to provide a long half-life.

The EC authorization of PRX-102 is based on results from a comprehensive clinical development program in more than 140 patients with up to 7.5 years of treatment. It has been studied in both ERT-nave and ERT-experienced patients, including a head-to-head trial that met its primary endpoint, with PRX-102 demonstrating non-inferior efficacy to agalsidase beta in controlling kidney disease as evaluated by the estimated glomerular filtration rate (eGFR) decline.

Pegunigalsidase alfa, an investigational new drug product, is currently not approved by the U.S. Food and Drug Administration (FDA). The effectiveness and safety of pegunigalsidase alfa is under review, but has not yet been approved, by the FDA. Prior to FDA review and approval, no conclusions can be drawn on pegunigalsidase alfa's efficacy and safety profile. When seeking expanded access, treating physicians should consider all possible risks of treatment with pegunigalsidase alfa. Access must be compliant with all applicable federal and state laws and regulations. Investigators should not seek reimbursement for product provided to patients who participate in a government funded insurance program.

About Fabry Disease

Fabry disease is an Xlinked inherited disease that results from deficient activity of the lysosomal GalactosidaseA enzyme resulting in progressive accumulation of abnormal deposits of a fatty substance called globotriaosylceramide (Gb3) in the lysosomes throughout a person's body. Fabry disease occurs in one person per 40,000 to 60,000. Fabry patients inherit a deficiency of the GalactosidaseA enzyme, which is normally responsible for the breakdown of Gb3. The abnormal storage of Gb3 increases with time and, accordingly, Gb3 accumulates, primarily in the blood vessel and tissues. The ultimate consequences of Gb3 deposition range from episodes of pain and impaired peripheral sensation to end-organ failure.

About PRX102

PRX102 (pegunigalsidase alfa) is a PEGylated enzyme replacement therapy (ERT) to treat Fabry disease that is now approved by the European Medicines Agency (EMA) and is under evaluation by the FDA. PRX-102 is a plant cell culture-expressed, and chemically modified stabilized recombinant version of the GalactosidaseA enzyme. Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties, resulting in a molecule with stable pharmacokinetic parameters. In clinical studies, PRX102 has been observed to have a circulatory half-life of approximately 80 hours.

About Chiesi Global Rare Diseases

Chiesi Global Rare Diseases is a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people affected by rare diseases. As a family business, Chiesi Group strives to create a world where it is common to have a therapy for all diseases and acts as a force for good, for society and the planet. The goal of the Global Rare Diseases unit is to ensure equal access so as many people as possible can experience their most fulfilling life. The unit collaborates with the rare disease community around the globe to bring voice to underserved people in the health care system.

For more information visit http://www.chiesirarediseases.com.

About Chiesi Group

Chiesi is an international, research-focused biopharmaceuticals group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care. The company's mission is to improve people's quality of life and act responsibly towards both the community and the environment.

By changing its legal status to a Benefit Corporation in Italy, the US, and France, Chiesi's commitment to create shared value for society as a whole is legally binding and central to company-wide decision-making. As a certified B Corp since 2019, we're part of a global community of businesses that meet high standards of social and environmental impact. The company aims to reach Net-Zero greenhouse gases (GHG) emissions by 2035.

With over 85 years of experience, Chiesi is headquartered in Parma (Italy), operates in 31 countries, and counts more than 6,500 employees. The Group's research and development centre in Parma works alongside 6 other important R&D hubs in France, the US, Canada, China, the UK, and Sweden.

For further information please visit http://www.chiesi.com.

About Protalix BioTherapeutics, Inc.

Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx. It is the first company to gain FDA approval of a protein produced through plant cell-based in suspension expression system. This unique expression system represents a new method for developing recombinant proteins in an industrial-scale manner. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights to taliglucerase alfa, Protalix's first product manufactured through ProCellEx, excluding in Brazil, where Protalix retains full rights.

Protalix's development pipeline consists of proprietary versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: pegunigalsidase alfa, a modified stabilized version of the recombinant human -Galactosidase-A protein for the treatment of Fabry disease; PRX-115, a plant cell-expressed recombinant PEGylated uricase for the treatment of severe gout; PRX-119, a plant cell-expressed long action DNase I for the treatment of NETs-related diseases; and others. Protalix has partnered with Chiesi Farmaceutici S.p.A., both in the United States and outside the United States, for the development and commercialization of pegunigalsidase alfa.

Protalix's Forward-Looking Statements

To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. The terms "expect," "anticipate," "believe," "estimate," "project," "may," "plan," "will," "would," "should" and "intend," and other words or phrases of similar import are intended to identify forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on Protalix's current beliefs and expectations as to such future outcomes. Factors that might cause material differences include, among others: risks related to the timing, progress and likelihood of final approval by the FDA of the resubmitted Biologics License Application (BLA) by the PDUFA action date, if at all, and, if approved, whether the FDA will impose significant limitations on the use of PRX102; risks related to the commercial success of PRX-102, and of Protalix's other product and product candidates, if approved; the likelihood that the FDA, EMA or other applicable health regulatory authorities will approve an alternative dosing regimen; failure or delay in the commencement or completion of preclinical studies and clinical trials of our other product candidates which may be caused by several factors, including: slower than expected rates of patient recruitment; unforeseen safety issues; determination of dosing issues; lack of effectiveness during clinical trials; inability to satisfactorily demonstrate non-inferiority to approved therapies; inability or unwillingness of medical investigators and institutional review boards to follow our clinical protocols; and inability to monitor patients adequately during or after treatment; delays in the approval or potential rejection of any applications we file with the FDA, EMA or other health regulatory authorities for our other product candidates, and other risks relating to the review process; risks associated with the novel coronavirus disease, or COVID19, outbreak, which may adversely impact our business, preclinical studies and clinical trials; the risk that the results of the clinical trials of our product candidates will not support the applicable claims of safety or efficacy, or that our product candidates will not have the desired effects or will be associated with undesirable side effects or other unexpected characteristics; risks related to our ability to maintain and manage our relationship with our collaborators, distributors or partners; our dependence on performance by third party providers of services and supplies, including without limitation, clinical trial services; the inherent risks and uncertainties in developing drug platforms and products of the type we are developing; the impact of development of competing therapies and/or technologies by other companies and institutions; potential product liability risks, and risks of securing adequate levels of product liability and other necessary insurance coverage; and other factors described in our filings with the U.S. Securities and Exchange Commission. The statements in this press release are valid only as of the date hereof and we disclaim any obligation to update this information, except as may be required by law.

Chiesi Group Media ContactChiara TravaginRare Communication ManagerTel: +39 348 8818985Email c.travagin@chiesi.com

Alessio PappagalloPress Office ManagerTel: +39 339 5897483Email a.pappagallo@chiesi.com

Adam DaleyBerry & Company Public Relations1-212-253-8881adaley@berrypr.com

Protalix Investor ContactChuck Padala, Managing DirectorLifeSci Advisors646-627-8390chuck@lifesciadvisors.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/chiesi-global-rare-diseases-and-protalix-biotherapeutics-announce-european-commission-authorization-of-prx-102-pegunigalsidase-alfa-for-the-treatment-of-fabry-disease-301817012.html

SOURCE Chiesi Global Rare Diseases; Protalix BioTherapeutics, Inc.

Company Codes: AMEX:PLX

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Chiesi Global Rare Diseases and Protalix BioTherapeutics ... - BioSpace

The National Agency for Food and Drug Administration and Control (NAFDAC) says toxic pesticides reportedly imported and sold in Nigeria will be reviewed and banned.

In a statement, Mojisola Adeyeye, director-general of NAFDAC, said some of the pesticides sold in Nigeria, particularly, chlorpyrifos contain toxic ingredients that are harmful to humans, animals, and the environment.

TheCable had earlier reported that a study by the Heinrich Bll Foundation, a non-governmental organisation, revealed there was a surge in the use of toxic pesticides by farmers in the country.

Commenting on the report by the Heinrich Bll Foundation, the NAFDAC DG said the agency was working to phase out all toxic pesticides imported into Nigeria.

The dangers posed by pesticides are of immense concern to the agency and there have been recent concerns from stakeholders such as the report of the study conducted by Heinrich Boll Foundation; a non-governmental organisation that claimed that 40 percent of pesticides used in Nigeria had been banned in the EU, the statement reads.

There was also an alert received from the federal ministry of agriculture and rural development (FMARD) cautioning on the possibility that the European Union and United Kingdom were exporting banned Neonicotinoid pesticides to Nigeria and other poorer countries.

Emphasis was placed on chlorpyrifos and its variants due to their harmful effects on humans, animals, beneficial insects, and the environment.

During her first term as the director-general, she gave a directive to review and analyze the list of registered pesticides and petrochemical active ingredients in the NAFDAC Registered Product Automated Database (NARPAD) vis--vis actives banned, non-approved, or restricted in the European Union, other countries or by relevant international organizations.

That led to several meetings with stakeholders and November 2022 meeting when timelines were set for the phase-out ban of the various pesticides.

Pesticides are applied both indoors and outdoors for the management of pests, vector-borne diseases, and for crop protection. They are sometimes impregnated in textiles, paints, carpets, and treated wood to control pests and fungi. However, the toxicity associated with the misuse and abuse of pesticides is worrisome as it affects food safety and food security.

The toxicity of pesticides is managed through stringent regulatory activities to reduce severe health implications on humans, crops, and the environment. This can be achieved through awareness and continual sensitization of stakeholders.

During the meeting on pesticide regulation, the agency said stakeholders resolved to ensure pesticides and agrochemical importers and manufacturers would be advised to institute stewardship plans, such as post-marketing surveillance and research in their companies.

NAFDAC to collaborate with research institutes in the conduct of research and scientific data generation on pesticides to enable the agency to make evidence-based decisions and policies, it added.

NAFDAC to intensify post-marketing surveillance nationwide.

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NAFDAC: All toxic pesticides banned in Europe but used in Nigeria ... - TheCable

European Commission

Vra Jourov says her upbringing in former Czechoslovakia has inspired her work to ensure journalism remains independent

Vra Jourov was 13 when she was first investigated for her political views. It was 1977 in communist Czechoslovakia and the state was cracking down on political dissidents who had signed a human rights declaration Charter 77. Her civics teacher wanted to know what she thought of the document. Jourovs parents were already blacklisted and she feared the wrong answer would make things worse. It was a horror moment, recalls Jourov, who knew about Charter 77 from the Voice of America and Radio Free Europe broadcasts that her family listened to in secret. So she said nothing and saw her school marks slide.

Nearly half a century later, Jourov is one of the European Commissions most powerful officials and seeking to protect the media in the European Union. There are increasing threats and a very dangerous trend, she told the Guardian.

On Wednesday, World Press Freedom day will be marked, during which global alarm about the state of media freedom is expected to be raised, and Jourov warned of the risks. Journalists are facing online and physical attacks, and are even killed for their work; public service media in some countries are pressured to become state or party mouthpieces; powerful businessmen are buying up outlets struggling to cope with the digital age, an oligarchisation that could endanger media pluralism, she said.

The European Commission vice-president was speaking in a week when the human rights watchdog Civil Liberties Union for Europe said abusive lawsuits against journalists were on the rise in a dozen EU countries. Meanwhile in four central European countries Poland, Hungary, the Czech Republic and Slovakia the majority of people told the Median pollster they were concerned about media freedom, an increase on last year in each state.

The European Commission, long a powerful regulator of the free market, used to argue it had no powers to defend the free press. EU treaties left the commission with weak equipment, Jourov said in defence of her predecessors. But starting her job as vice-president for values and transparency in 2019, she realised passivity might be a fatal mistake.

If we understand the rule of law principle as a healthy and functioning division of powers, then of course the media belong to this game. A year ago she proposed measures to protect journalists and campaigners from vexatious lawsuits, so-called strategic lawsuits against public participation, or Slapps, used by wealthy individuals and companies attempting to quash investigative reporting. This was followed last autumn with the proposed European media freedom act, intended to prevent political interference in editorial decisions, ensure the independence of public service media and ban the use of spyware on journalists.

The proposal has to be agreed by EU governments and the European parliament. Not everyone is enthusiastic. The German government, under pressure from powerful media groups that dislike the plans, such as Axel Springer, the owner of Bild and Politico, argues that EU regulation could dilute national media protections. Jourov insists this is not the case, because the legislation proposes minimum standards. Even countries, with long traditions of free media, such as Denmark, should not be complacent, she suggested. My message is no country is immune, for instance, against the appetite of politicians to interfere into the job of journalists.

Meanwhile the European parliaments lead negotiator on the file, the German centre-right MEP Sabine Verheyen, is seeking to weaken aspects of the proposals. She wants to protect the rights of media owners to assume a leading editorial role. Jourov insists the EU regulation cannot be a cosmetic change The media sector needs a radical solution when it comes to its protection, she said.

In contrast the Committee to Protect Journalists has welcomed the various EU plans but warned that the EU shift to protect the media still needed to be translated into meaningful action.

The proposed media freedom act, Jourov acknowledged, cannot undo the damage in some member states, such as Hungary, where last year independent election monitors found that biased and unbalanced news coverage in favour of the ruling party had limited voters ability to make a choice. We cannot unscramble scrambled eggs, Jourov said, referring to Kesma, Hungarys rightwing pro-government media group spanning TV companies, internet portals, newspapers and sports publications that dominates the news agenda. But I believe that the media freedom act might have an influence on the behaviour of the states including Hungary, she said, suggesting the possibility of EU legal action would limit future moves to control journalism.

Inspired by her own upbringing, the Czech politician also wants to support Russias exiled independent journalists, now labelled foreign agents by the Kremlin. She says the creation of Radio Free Russia will help Russian independent journalists in the EU find an audience in their home country. Rather than just a radio station, she proposes a broader set of initiatives to fund and help journalists working for the likes of the Dozhd TV station, Novaya Gazeta and the Meduza internet portal. The EU has set aside 3m (2.65m) in seed funding to create a media freedom hub that will give grants and raise money for Russian media groups that have lost their business model. The hub, the centrepiece of Radio Free Russia, is intended to launch on 1 July and will also help exiled Russian journalists get humanitarian visas and bank accounts.

I believe that there might be a lot of people in Russia, who want to hear something else, said Jourov, seated in front of a large portrait of Anna Politikovskaya, the campaigning Russian reporter murdered in 2006. It would be a mistake not to support independent Russian journalists on EU territory, she said.

She remembered the horrible brainwash of her youth, countered by secret listening to the free media. Without Voice of America, I only would have known that Vclav Havel [dissident and later statesman] and others were enemies of the people, she said recalling the stations jaunty Yankee Doodle jingle. The official doctrine was very intense.

Radio Free Russia would also help Russian journalists distribute their work in their home country, whether via VPN, satellite or the internet. We cannot remove the fear I know what it is to live in such a kind of fear but we can remove the lack of information, with the Radio Free Russia initiative.

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Threats are increasing: the EU official on a mission to protect media freedom - The Guardian