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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

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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

Danielle Smiths tattoo has caught the attention of the internet, with some arguing on social media that she has the logo for a right-wing libertarian think tank on her forearm.

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The tattoo was done by her stepson, a Calgary tattoo artist. Its an ancient Sumerian cuneiform symbol for liberty or freedom.

That same symbol also happens to feature in the logo for the Liberty Fund, a libertarian think tank headquartered in Indiana.

We believe that the first written reference to the concept of liberty is the ancient Sumerian cuneiform symbol amagi which Liberty Fund uses as its logo, the Liberty Fund website states. The translation of the inscription literally means return to the mother.'

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While the Liberty Fund does clearly use the symbol in its logo, that doesnt mean Smith got the tattoo to represent the group. Just as a person with a tattoo of a maple leaf couldnt be accused of being a Toronto hockey fan, or a supporter of the Liberal Party of Canada, or an Ironman triathlon finisher.

Smith recently told National Post that she learned about the Sumerian word during her days at the Fraser Institute, another libertarian-adjacent think tank, having seen the Liberty Fund logo, and loved the symbol and its history.

I always thought if I ever have a tattoo, thats what it would be, Smith said.

Liberty and freedom has been one of the things that Ive written an awful lot about.

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While the symbol is often translated as liberty or freedom, there seems to be some debate among scholars over whether it simply means freedom from a debt and should not be used more broadly.

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Does UCP leader Danielle Smith have a tattoo of a right-wing think tank? Not really - National Post

U.S. Sen. Martin Heinrich released a campaign video Thursday announcing his run for re-election in 2024.

When I look at Washington these days, I see plenty of fighters, Heinrich, a Democrat, said in the video. The problem is too many are fighting for themselves for their career and their big donors. The way I see it, you hired me to work for you. And I want you to know, Im all in.

Heinrich is seeking his third term in the U.S. Senate. Before winning election to the U.S. Senate in 2012, Heinrich served as a member of Congress for two terms, representing the states 1st Congressional District.

Heinrich won a three-way race for reelection in 2018, defeating Republican construction company owner Mick Rich and former Gov. Gary Johnson, who ran as a Libertarian.

The video, entitled, All In and included a listing of the things Heinrich was all in for in recent years.

These things include how he tried to curb gun violence, expanded veteran health care benefits, helped to get $4 billion to help communities affected by last years wildfires, worked to lower prescription costs and brought more than $1 billion for New Mexicos infrastructure, the video states.

Im running for the Senate again, because we still have more work to do, Heinrich said in the video. We have to take on the challenges that have been written off for too long. We need to diversify New Mexicos economy. We have to continue the transition to clean energy. We have to build upon our historic investment in early childhood education.

He has a background in engineering including a contract with what is now the Air Force Research Laboratory at Kirtland Air Force Base working on directed energy technology.

Democrats currently hold a small majority in the Senate, 51-49, over Republicans. The 2024 elections are considered friendly to Republicans in at least three states currently represented by Democrats.

Cook Political Report, Crystal Ball and Inside Elections all project New Mexico to be a strong Democratic state.

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Heinrich 'All In' for Senate re-election bid - New Mexico Political Report