May 31, 2024

Fortrea Apresenta Solução Abrangente para Aprimorar a Diversidade e Inclusão na Pesquisa Clínica

Utilizando dados do mundo real, insights de pacientes e um processo sistemático para a criação, operação e análise da eficácia dos planos de ação de diversidade em ensaios clínicos

DURHAM, N.C., May 31, 2024 (GLOBE NEWSWIRE) — A Fortrea (Nasdaq: FTRE) (a “Empresa”), uma organização líder global de pesquisa por contrato (CRO), anunciou hoje o lançamento da sua solução abrangente e integrada para a melhoria da diversidade e inclusão (D&I) dos participantes em ensaios clínicos. A solução de D&I da Fortrea foi projetada para expandir o acesso dos pacientes a participar de ensaios clínicos e atender aos requisitos da Food and Drug Administration (FDA) dos EUA, sob a Lei de Reforma Omnibus de Alimentos e Medicamentos, para aumentar a inscrição de populações sub-representadas em ensaios clínicos.

O processo abrangente da Fortrea integra cinco componentes do planejamento e execução de ações de diversidade:

Consultores de evidências do mundo real pesquisam conjuntos de dados relevantes do mundo real para informar o planejamento da diversidade.
Especialistas em regulamentação, desenvolvimento e operações clínicas elaboram o Plano de Ação de Diversidade, validam com grupos de pacientes e negociam com os reguladores.
As equipes operacionais acessam várias plataformas de dados, o Conselho Consultivo de Locais da Fortrea e soluções habilitadas por tecnologia para implementar o Plano de Ação de Diversidade como parte integrante da execução dos ensaios clínicos da Fortrea.
O monitoramento e os relatórios são habilitados pelo exclusivo Painel de Insights de Estudo de Diversidade e Inclusão da Fortrea, fornecendo dados e visualizações acionáveis para o gerenciamento contínuo do estudo.
Escritores técnicos de relatórios experientes compilam dados e preparam relatórios para envio regulatório, com suporte regulatório contínuo fornecido como parte da solução de D&I.

“A pesquisa clínica que reflete uma população representativa fornece uma melhor visão de como um tratamento potencial funcionará em um ambiente do mundo real”, disse John Doyle, DrPH, presidente da Fortrea Consulting. “Requisitos regulatórios recentes codificam o progresso dos últimos anos na abordagem biofarmacêutica para aumentar a inclusão de diversas populações nos seus programas de desenvolvimento. A solução da Fortrea traz uma profunda experiência em dados do mundo real para projetar planos de D&I eficazes e realistas, juntamente com mais de 30 anos de experiência em mais de 20 áreas terapêuticas na execução de testes. Também temos um compromisso firme com a D&I, não apenas nos ensaios clínicos, mas em toda a nossa empresa, à medida que buscamos nosso propósito de oferecer tratamentos que mudam a vida dos pacientes mais rapidamente.”

A solução de D&I da Fortrea incorpora uma série de ferramentas proprietárias, incluindo avaliações epidemiológicas e de viabilidade que utilizam uma combinação exclusiva de grandes conjuntos de dados. A solução também integra contribuições de grupos de pacientes para criar insights sobre a tolerância ao protocolo e os requisitos de suporte à conduta do estudo em diferentes populações de pacientes em várias áreas e geografias da terapia. Esses insights informam os planos globais e locais de recrutamento e retenção de pacientes para o alcance de populações de pacientes sub-representadas e abordagem das barreiras à participação de ensaios clínicos.

“Para a garantia da inclusão de diversas populações de pacientes em ensaios clínicos precisamos ir além de um plano, precisamos ter discernimento e agir”, disse Mark Morais, diretor de operações da Fortrea. “Devido ao nosso abrangente programa Voz do Paciente e à nossa colaboração com diversos locais de pesquisa e redes de locais, temos um profundo entendimento do que é necessário para o sucesso no alcance de populações que tradicionalmente têm sido sub-representadas nos ensaios clínicos. Na Fortrea, somos informados pelos dados do mundo real, habilitados pelas tecnologias inovadoras e impulsionados pela nossa paixão em oferecer novas terapias para todos os pacientes.”

Visite Diversidade e Inclusão em Ensaios Clínicos em Fortrea.com para mais informação.

Sobre a Fortrea

A Fortrea (Nasdaq: FTRE) é fornecedora líder global de soluções para o desenvolvimento clínico e acesso ao paciente para a indústria de ciências da vida. Fazemos parcerias com grandes e emergentes empresas biofarmacêuticas, de biotecnologia, de dispositivos médicos e de diagnóstico para impulsionar a inovação na saúde que acelera terapias que mudam a vida dos pacientes. A Fortrea fornece gerenciamento de testes clínicos de fase I-IV, farmacologia clínica, serviços de consultoria, soluções de testes com tecnologia diferenciada e serviços pós-aprovação.

As soluções da Fortrea utilizam suas três décadas de experiência abrangendo mais de 20 áreas terapêuticas, sua dedicação ao rigor científico, insights excepcionais e uma forte rede de pesquisadores. Nossa equipe talentosa e diversificada que trabalha em mais de 90 países é dimensionada para fornecer soluções focadas e ágeis para clientes de todo o mundo.

Saiba mais sobre como a Fortrea está se tornando uma força transformadora de pipeline para paciente na Fortrea.com e siga-nos no LinkedIn e X (antigo Twitter) @Fortrea.

Contatos da Fortrea:
Fortrea para Mídia: Galen Wilson – 703-298-0802, media@fortrea.com
Fortrea para Mídia: Kate Dillon – 646-818-9115, kdillon@prosek.com

GlobeNewswire Distribution ID 9146941

May 31, 2024

Fortrea lance une solution complète pour améliorer la diversité et l’inclusion dans la recherche clinique

Exploitation des données en conditions réelles, des connaissances des patients et adoption d’un processus systématique pour développer, concrétiser et mesurer l’efficacité des plans d’action en faveur de la diversité dans les essais cliniques.

DURHAM, État de Caroline du Nord, 31 mai 2024 (GLOBE NEWSWIRE) — Fortrea (Nasdaq : FTRE), ci-après la « Société », une organisation de recherche contractuelle (ou ORC) leader d’envergure mondiale, annonce ce jour la sortie de sa solution complète et intégrée ciblée sur l’amélioration de la diversité et de l’inclusion des participants aux essais cliniques. La solution « Diversité et Inclusion » développée par Fortrea est conçue pour élargir l’accès des patients aux essais cliniques et répondre aux exigences de la loi fédérale Food and Drug Omnibus Reform Act édictée par l’administration américaine des denrées alimentaires et des médicaments, la Food and Drug Administration, ou « FDA » visant à renforcer le recrutement des populations sous-représentées dans les essais cliniques.

L’approche globale de Fortrea intègre cinq axes de planification et d’exécution d’actions en faveur de la diversité :

Recherche des ensembles de données pertinentes en conditions réelles pilotée par les conseillers en vue de contribuer à la planification de la diversité.
Mise au point du plan d’action en faveur de la diversité élaborée par les experts en réglementation, développement et services cliniques, validation auprès des groupes de patients et négociations avec les autorités de tutelle réglementaires.
Mise en accès à de multiples plateformes de données pour les équipes opérationnelles, ainsi qu’au comité consultatif de site et à des solutions technologiques pour actionner le plan d’action en faveur de la diversité, pleinement intégré à l’exécution des essais cliniques à la main de Fortrea.
Suivi et reporting assurés par le tableau de bord exclusif de la solution dédié aux éclairages sur les données relatives aux notions de diversité et d’inclusion des études (Diversity and Inclusion Study Insights Dashboard), fournissant des données et des graphiques exploitables dans le cadre de la gestion continue de l’étude.
Compilation des données effectuée par des rédacteurs techniques expérimentés veillant également à la préparation des rapports en amont des dépôts auprès des autorités réglementaires, et appui réglementaire permanent intégré à la solution.

Pour John Doyle, docteur en santé publique et Président de Fortrea Consulting, « La recherche clinique reposant sur une population représentative donne une meilleure idée des modalités de fonctionnement d’un potentiel traitement en conditions réelles. Les nouvelles exigences réglementaires traduisent les progrès réalisés ces dernières années dans l’approche biopharmaceutique visant à améliorer l’inclusion de populations diverses au sein des programmes de développement. La solution de Fortrea apporte une expertise approfondie des données en conditions réelles pour concevoir des plans ciblés sur la diversité et l’inclusion efficaces et réalistes, et plus de 30 ans d’expérience dans plus de 20 disciplines thérapeutiques en matière d’exécution d’essais. Notre engagement sans faille envers la diversité et l’inclusion dépasse les frontières des essais cliniques pour s’étendre à l’ensemble de notre entreprise, à l’heure où nous poursuivons notre objectif de mettre plus rapidement à la disposition des patients des traitements susceptibles de changer leur vie ».

La solution « Diversité et Inclusion » développée par Fortrea intègre une série d’outils exclusifs, notamment des évaluations épidémiologiques et de faisabilité qui s’appuient sur une combinaison exclusive de vastes ensembles de données. Elle intègre également des données provenant de groupes de patients pour fournir des éclairages sur la tolérance au protocole et les exigences en matière de soutien à la conduite de l’étude pour différentes populations de patients, dans plusieurs disciplines thérapeutiques et territoires. Ces éclairages permettent d’élaborer des plans de recrutement et de fidélisation des patients à l’échelle mondiale et locale, d’atteindre les populations de patients sous-représentées et d’éliminer les obstacles à la participation aux essais cliniques.

« Garantir l’inclusion de diverses populations de patients dans les essais cliniques doit s’entendre au-delà d’un plan, ce qui demande de la perspicacité et de l’action », observe Mark Morais, chef de l’exploitation de Fortrea, avant d’ajouter : « Grâce à notre programme complet Voice of Patient (la voix des patients) et à notre collaboration avec divers centres investigateurs et réseaux de centres, nous comprenons parfaitement ce qu’il faut faire pour toucher les populations habituellement sous-représentées dans les essais cliniques. Chez Fortrea, nous nous appuyons sur des données en conditions réelles issues de technologies innovantes, et nous sommes animés d’une passion axée sur la proposition de nouveaux traitements à tous les patients. »

Pour en savoir plus, veuillez consulter la page Diversité et inclusion dans les essais cliniques sur le site Fortrea.com.

À propos de Fortrea

Fortrea (Nasdaq : FTRE) figure parmi les principaux fournisseurs de solutions de développement clinique et d’accès aux soins pour les patients dans le secteur des sciences de la vie. Nous nous associons à des entreprises émergentes et établies du secteur biopharmaceutique, de la biotechnologie, des dispositifs médicaux et du diagnostic pour stimuler l’innovation dans le domaine de la santé et accélérer la mise à disposition de traitements révolutionnaires pour les patients. Nous proposons des services de gestion d’essais cliniques de phase I à IV, de pharmacologie clinique, de conseil, d’essais différenciés axés sur des technologies habilitantes, et des services post-autorisation.

Nos solutions s’appuient sur 30 ans d’expérience dans 20 disciplines thérapeutiques, une passion pour la rigueur scientifique, des connaissances exceptionnelles et un solide réseau de centres de recherche. Notre équipe talentueuse et diversifiée répartie dans plus de 90 pays est dimensionnée pour fournir des solutions ciblées et agiles à nos clients, partout dans le monde.

Pour en savoir plus sur la manière dont Fortrea est moteur d’influence du pipeline au patient, consultez le site Fortrea.com et suivez-nous sur LinkedIn et X (anciennement Twitter) @Fortrea.

Coordonnées :
Relations médias : Galen Wilson – 703-298-0802, media@fortrea.com
Relations médias : Kate Dillon – 646-818-9115, kdillon@prosek.com

GlobeNewswire Distribution ID 9146941

May 31, 2024

Nyxoah Announces Closing of Offering and Partial Exercise of Option to Purchase Additional Shares

INSIDE INFORMATION
REGULATED INFORMATION

Nyxoah Announces Closing of Offering and Partial Exercise of
Option to Purchase Additional Shares

Mont-Saint-Guibert, Belgium – May 31, 2024, 8:00am CET / 2:00am ET – Nyxoah SA (Euronext Brussels/ Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced the closing of its previously announced underwritten public offering in the United States, which included shares sold in a private offering to certain qualified or institutional investors outside the United States, including within the European Union, in which 5,374,755 shares of its ordinary shares were sold at an offering price of $9.25 (EUR 8.54) per share, before underwriting discounts and commissions. This resulted in total gross proceeds, before deducting underwriting discounts and commissions and other offering expenses payable by Nyxoah, of approximately $50 million (EUR 45.9 million).

In addition, Nyxoah announced today that the underwriters of the Offering have exercised their option to purchase additional shares for 300,000 shares at the public offering price of $9.25 (EUR 8.54) per share, before underwriting discounts and commissions. This exercise will bring the total gross proceeds of the Offering to approximately $52.5 million (EUR 48.5 million) before deducting underwriting discounts and commissions and estimated offering expenses. The closing of the exercise of the option to purchase 300,000 additional shares is expected to occur on June 3, 2024, subject to the satisfaction of customary closing conditions.

Nyxoah intends to use the net proceeds from the proposed offering (i) for pre-commercialization and commercialization activities in the United States; (ii) to continue gathering clinical data and to support physician initiated clinical research projects related to OSA patient treatments; (iii) to further finance research and development activities related to the next generation of the Genio system and to continue to build a pipeline of new technologies and explore potential collaboration opportunities in the field of monitoring and diagnostics for OSA; and (iv) for other general corporate purposes, including, but not limited to, working capital, capital expenditures, investments, acquisitions, should the Company choose to pursue any, and collaborations.

Cantor Fitzgerald & Co. acted as the sole book-running manager for the offering. Degroof Petercam acted as a co-manager.

The public offering in the United States was made pursuant to an effective shelf registration statement on Form F-3 (File No. 333-268955) that was filed by Nyxoah with the U.S. Securities and Exchange Commission (the “SEC”) and became effective on January 6, 2023. Copies of the final prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering are available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus may be obtained by contacting Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59^th Street, 6^th Floor, New York, New York 10022; email: prospectus@cantor.com.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Nyxoah
Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat OSA. Nyxoah’s lead solution is the Genio® system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest.

Caution – CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States.

Forward-Looking Statements
This press release contains forward-looking statements, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements may be identified by words such as “expects,” “potential,” “could,” or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements include express or implied statements relating to, among other things, Nyxoah’s current expectations regarding the Genio® system; planned and ongoing clinical studies of the Genio® system; the potential advantages of the Genio® system; Nyxoah’s goals with respect to the development, regulatory pathway and potential use of the Genio® system; the utility of clinical data in potentially obtaining FDA approval of the Genio® system; the Company’s results of operations, financial condition, liquidity, performance, prospects, growth and strategies; and statements relating to the offering, including the expected closing, the anticipated proceeds from the offering and the use thereof. These statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, many of which are beyond Nyxoah’s control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. In particular, these risks and uncertainties include, without limitation, risks relating to market conditions and the Company’s inability, or the inability of the underwriters, to satisfy the conditions for the closing of the offering. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. Other risks and uncertainties faced by Nyxoah include those identified under the heading “Risk Factors” in Nyxoah’s most recent Annual Report on Form 20-F filed with the SEC, as well as subsequent filings and reports filed with the SEC. The forward-looking statements contained in this press release reflect Nyxoah’s views as of the date hereof, and Nyxoah does not assume and specifically disclaims any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

Contact:
Nyxoah
David DeMartino, Chief Strategy Officer

IR@nyxoah.com

Attachment

ENGLISH_Financing Closing and Exercise of Greenshoe Press Release – May 2024

GlobeNewswire Distribution ID 1000963842

May 31, 2024

Training workshop on cybercrime in Sana’a

A training workshop on electronic crimes began in Sana’a.

At the opening, a member of the Supreme Court stressed the importance of the workshop, which the first of the activities of the Advanced Training Reference, as it carried out with the participation of an elite group of legal academics and specialists to reflect their legal expertise.

Source: Yemen News Agency

May 31, 2024

Justice: France, Morocco Bound by ‘Very Close Active Solidarity’ (French Minister)

The judicial and legal field is ‘a perfect illustration of the unique common destiny’ between France and Morocco, two countries bound by ‘a very close active and reciprocal solidarity’ in this area, French Justice Minister Eric Dupond Moretti said on Friday in Rabat.

In a statement to the press following the signing of a technical cooperation action plan between Morocco and France, Dupond Moretti added that the two countries are engaged in a process of digital transformation aimed at making justice more accessible, faster, more protective and more efficient.

The French Justice Minister also underlined the unique common destiny linking the two countries, based in particular on the proximity of their legal and judicial systems.

With regard to the technical cooperation action plan, Dupond Moretti pointed out that both parties aspire to achieve a number of objectives, including modernizing the justice system and reinforcing its efficiency, digitizing procedures and structuring jurisdictions administratively.

A
ccording to the French Minister, exchanges will be scheduled in the very near future to share the expertise of both parties on specific subjects, including the dematerialization of civil and criminal proceedings, the tools made available to magistrates and judicial staff, and the possibilities offered to litigants to bring cases before the courts and monitor their affairs online.

These exchanges will also cover the training of registry staff and the fight against violence against women and domestic violence, he said.

Source: Agence Marocaine De Presse 31 May 2024

May 31, 2024

Marchs in Dhalea entitled ‘With Gaza’

Dhalea governorate witnessed major marches in support of the Palestinian people and a victory for Al-Aqsa entitled ‘With Gaza, regardless of the challenges.’

Participants in the marches raised slogans of absolute support for the revolutionary leadership in making appropriate choices to support the resistance.

The people of Dhalea condemned the raids launched by the American-British Zionist enemy on civilian objects, which resulted in dozens of martyrs and wounded.

Source: Yemen News Agency