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Inteleos Opens Africa Office to Advance Basic Obstetric Point of Care Ultrasound (OPOCUS) Certification Across East Africa

ROCKVILLE, Md. and NAIROBI, Kenya, Oct. 30, 2025 (GLOBE NEWSWIRE) — Inteleos, a global nonprofit healthcare certification organization, expands its commitment to working on the ground in Africa to elevate the standard of global healthcare with the opening of an office with a dedicated, local team in Nairobi, Kenya. Inteleos Africa, opened in October 2025, will focus on improving the quality of and access to Point–of–Care Ultrasound (POCUS) education and certification in East Africa and beyond.

Improving Outcomes Through Certification

Through education and validation of clinical proficiency by certification, the ultimate goal is to improve maternal and fetal health outcomes. In addition, certification stands to expand economic and employment opportunities for frontline clinicians, especially midwives and nurses. Inteleos will continue its prior work in Kenya in collaboration with the Ministry of Health and their new certification requirements to set standards that other nations will follow as a model for improving maternal–fetal outcomes.

“Certification ensures that the pockets and pilots of POCUS training meet the global standard of proficiency while aligning with the local scope of practice. This ensures sustainable proficiency and accessible quality of care,” noted Pamela Ruiz, Chief Business Development Officer at Inteleos. “Our ongoing collaboration with Kenya’s Ministry of Health and stakeholders on the ground shows how local and global leadership can drive meaningful change.”

Global Experience, Local Impact

Inteleos and its related organizations bring a 50–year legacy of working with communities of practice and institutions to ensure equitable access to quality care through sonography and other imaging certification, including POCUS and obstetric POCUS (OPOCUS) certification programs. Inteleos has certified more than 150,000 healthcare practitioners of varying levels in 113 different countries. As a leading provider of certification in Africa, Inteleos has actively worked in Kenya for the last three years and also brings certifications to the country that are ISO certified.

The first Inteleos Africa executive is Steven Opondo, the new Director of Partnerships and Growth. “Kenya is pioneering approaches that will help transform healthcare outcomes regionally,” said Mr. Opondo. “Having an Inteleos Africa team on the ground will accelerate adoption of international standards and benefit patients across Africa.”

Nairobi was chosen as the location for Inteleos’ first Africa office since Kenya is at the forefront of setting standards and policies that will transform patient care. While OPOCUS certifications are accepted across the globe, Kenya is the only nation that requires certification for OPOCUS trainers. The Kenya Ministry of Health has set out the certification requirements as a part of its National Obstetrics Point of Care Ultrasound (O–POCUS) Guidelines, with the goal of improving maternal and fetal health outcomes.

Supporting Growth and Collaboration

Inteleos Africa will participate in two upcoming events: The Kenya Medical Association OPOCUS training and certification event in late October and the African Venture Philanthropy Alliance (AVPA) conference in early November.

For more information on Inteleos Africa, visit Inteleos.org/Africa_office.

About Inteleos

Inteleos™ is a non–profit organization dedicated to ensuring equitable access to quality healthcare globally. It oversees the American Registry for Diagnostic Medical Sonography® (ARDMS®), the Alliance for Physician Certification & Advancement™ (APCA™), and the Point–of–Care Ultrasound Certification Academy™ (PCA), collectively representing 150,000 certified medical professionals worldwide. The Inteleos Foundation manages the organization’s philanthropic initiatives. Learn more at Inteleos.org.


GLOBENEWSWIRE (Distribution ID 9563521)

Curia Invests $4 Million to Enhance Sterile API Manufacturing

ALBANY, N.Y., Oct. 27, 2025 (GLOBE NEWSWIRE) — Curia Global, Inc. (Curia), a leading global research, development and manufacturing organization, today announced the completion of a $4 million investment to upgrade its two API aseptic suites in Valladolid, Spain. The investment aligns with the latest EU GMP Annex 1 standards and reinforces Curia’s longstanding commitment to regulatory excellence and product quality. Annex 1 provides general guidance for the design and control of facilities, equipment, systems and procedures used for the manufacture of all sterile products, applying the principles of Quality Risk Management (QRM) to prevent microbial, particulate and endotoxin contamination in the final product.

The enhancements support upgrades to Valladolid’s infrastructure and technology. Curia used innovative tools to take advantage of new possibilities derived from the application of an enhanced process understanding. The bulk of the investment was dedicated to updating the site’s equipment, including the installation of new isolators, along with modernizations to HVAC, pharmaceutical panels, automation, sterilization in place and general utilities. Transitioning to a fully closed system was the primary driver of these upgrades, with the goal of supporting process and product safety and preventing microbiological contamination at every step of production. Additionally, ergonomic improvements for operators were key to increasing operational safety, along with the implementation of additional automatic controls in line with stricter data integrity policies, as described in 21 CFR Part 11.    

“Quality and compliance are integral to how we operate,” said Philip Macnabb, CEO of Curia. “The new Annex 1 requirements align with our proactive approach to quality control. We always strive to offer our customers the highest level of assurance when it comes to compliance and our ability to deliver high–quality sterile APIs at scale. Customers depend on us for reliability, precision and trust. With these improvements at Valladolid, they can feel confident that we will continue to invest ahead of industry trends as we partner with them to bring their products to market.”

The updates at Valladolid followed a company–wide evaluation across Curia’s global network to identify opportunities for improvement related to new Annex 1 requirements. The assessment examined procedures, equipment, utilities, qualifications, and validations to create solutions tailored to each site and to address any areas for optimization.

Curia’s global API aseptic processing manufacturing network has served a broad portfolio of customers worldwide for more than 20 years. This investment positions the company to support increasingly complex manufacturing projects, while strengthening its commitment to delivering life–changing medicines with uncompromising quality and reliability.

About Curia
Curia is a contract research, development and manufacturing organization (CDMO) with over 30 years of experience, an integrated network of 20 global sites and 3,200 employees partnering with biopharmaceutical customers to bring life–changing therapies to market. Our offerings in small molecule, generic APIs, sterile drug product and biologics span discovery through commercialization, with integrated regulatory, analytical and sterile fill–finish capabilities. Our scientific and process experts, along with our regulatory–compliant facilities, provide a best–in–class experience across drug substance and drug product manufacturing. From curiosity to cure, we deliver every step to accelerate your research and improve patients’ lives. Visit us at curiaglobal.com.

Corporate Contact:
Viana Bhagan
Curia
+1 518 512 2111
[email protected]


GLOBENEWSWIRE (Distribution ID 9552034)

Curia Investe US $4 Milhões para Aprimorar a Fabricação de APIs Estéreis

ALBANY, N.Y., Oct. 27, 2025 (GLOBE NEWSWIRE) — Curia Global, Inc. (Curia), uma organização líder global em pesquisa, desenvolvimento e fabricação, anunciou hoje a conclusão de um investimento de US $4 milhões para atualizar suas duas suítes assépticas de API em Valladolid, Espanha. O investimento está alinhado com os mais recentes padrões do Anexo 1 de BPF da UE e confirma o compromisso de longa data da Curia com a excelência regulatória e a qualidade do produto. O Anexo 1 fornece orientações gerais para o projeto e controle de instalações, equipamentos, sistemas e procedimentos utilizados para a fabricação de todos os produtos estéreis, aplicando os princípios de Gerenciamento de Risco da Qualidade (QRM) para prevenir a contaminação microbiana, particulada e de endotoxina no produto final.

Estes aprimoramentos são compatíveis com as atualizações da infraestrutura e tecnologia da Valladolid. A Curia usou ferramentas inovadoras para aproveitar novas possibilidades derivadas da aplicação de uma compreensão aprimorada do processo. A maior parte do investimento foi dedicada à atualização dos equipamentos do local, incluindo a instalação de novos isoladores, juntamente com modernizações de HVAC, painéis farmacêuticos, automação, esterilização no local e utilidades gerais. A transição para um sistema totalmente fechado foi o principal impulsionador dessas atualizações, com o objetivo de apoiar a segurança do processo e do produto e prevenir a contaminação microbiológica em cada etapa da produção. Além disso, os aprimoramentos ergonômicos para os operadores foram fundamentais para aumentar a segurança operacional, juntamente com a implementação de controles automáticos adicionais de acordo com políticas de integridade de dados mais rigorosas, de acordo com 21 CFR Parte 11.    

“A qualidade e a conformidade são essenciais para a nossa operação”, disse Philip Macnabb, CEO da Curia. “Os novos requisitos do Anexo 1 se alinham com nossa abordagem proativa ao controle de qualidade. Sempre nos esforçamos para oferecer aos nossos clientes o mais alto nível de garantia quando se trata de conformidade e da nossa capacidade de fornecer APIs estéreis de alta qualidade em escala. Os clientes dependem de nós para confiabilidade, precisão e confiança. Com essas melhorias em Valladolid tem a confiança de que continuaremos a investir à frente das tendências do setor à medida que nos associamos a eles para levar seus produtos ao mercado.”

As atualizações em Valladolid seguiram uma avaliação de toda a empresa em toda a rede global da Curia para identificar oportunidades de melhoria relacionadas aos novos requisitos do Anexo 1. A avaliação analisou procedimentos, equipamentos, utilidades, qualificações e validações para criar soluções adaptadas a cada local e abordar quaisquer áreas para otimização.

A rede global de fabricação de processamento asséptico de API da Curia atende a um amplo portfólio de clientes em todo o mundo há mais de 20 anos. Esse investimento posiciona a empresa a apoiar projetos de fabricação cada vez mais complexos, ao mesmo tempo em que fortalece seu compromisso de fornecer medicamentos com qualidade e confiabilidade intransigentes que mudam a vida.

Sobre a Curia
A Curia é uma Organização de Desenvolvimento e Fabricação por Contratos (CDMO) com mais de 30 anos de experiência, uma rede integrada de 20 locais em todo o mundo e 3.200 funcionários em parcerias com clientes biofarmacêuticos para lançamento no mercado terapias que mudam a vida. Nossas ofertas de pequenas moléculas, APIs genéricos, produtos de medicamentos estéreis e produtos biológicos resultam em descobertas através da comercialização, com integridade regulatória, de capacidade analítica e processamento final estéril. Nossos especialistas científicos e de processos, juntamente com nossas instalações em conformidade regulatórias, oferecem a melhor experiência em fabricação de medicamentos e produtos farmacêuticos. Da curiosidade à cura, proporcionamos todas as etapas necessárias para acelerar sua pesquisa e melhorar a vida dos pacientes. Visite–nos em curiaglobal.com.

Contato Corporativo:
Viana Bhagan
Curia
+1 (518) 512 2111
[email protected]


GLOBENEWSWIRE (Distribution ID 9562221)

Curia investiert 4 Mio. US-Dollar in die Optimierung der Herstellung steriler Wirkstoffe

ALBANY, New York, Oct. 27, 2025 (GLOBE NEWSWIRE) — Curia Global, Inc. (Curia), ein weltweit führendes Forschungs–, Entwicklungs– und Produktionsunternehmen, gab heute den Abschluss einer 4 Millionen US–Dollar schweren Investition zur Modernisierung seiner beiden aseptischen API–Anlagen in Valladolid, Spanien, bekannt. Die Investition entspricht den neuesten Standards des EU–GMP–Anhangs 1 und unterstreicht das langjährige Engagement von Curia für regulatorische Exzellenz und Produktqualität. Anhang 1 enthält allgemeine Leitlinien für die Gestaltung und Kontrolle von Anlagen, Ausrüstung, Systemen und Verfahren, die für die Herstellung aller sterilen Produkte verwendet werden. Dabei werden die Grundsätze des Qualitätsrisikomanagements (QRM) angewendet, um eine Kontamination des Endprodukts mit Mikroorganismen, Partikeln und Endotoxinen zu verhindern.

Die Verbesserungen unterstützen die Modernisierung der Infrastruktur und Technologie in Valladolid. Curia nutzte innovative Tools, um neue Möglichkeiten zu erschließen, die sich aus einem verbesserten Prozessverständnis ergaben. Der Großteil der Investitionen floss in die Modernisierung der Anlagen am Standort. Dazu gehörten die Installation neuer Isolatoren, die Modernisierung der Klimaanlagen, der pharmazeutischen Schalttafeln, der Automatisierung, der Sterilisation vor Ort sowie der allgemeinen Versorgungsanlagen. Der Hauptgrund für diese Modernisierungen war der Übergang zu einem vollständig geschlossenen System. Damit sollten die Prozess– und Produktsicherheit gewährleistet und mikrobiologische Kontaminationen in jeder Phase der Produktion verhindert werden. Ergonomische Verbesserungen waren darüber hinaus für die Erhöhung der Betriebssicherheit von entscheidender Bedeutung. Ebenso wichtig war die Implementierung zusätzlicher automatischer Kontrollen gemäß den strengeren Richtlinien zur Datenintegrität, wie in 21 CFR Part 11 beschrieben.    

„Qualität und Compliance sind wesentliche Bestandteile unserer Geschäftstätigkeit“, sagte Philip Macnabb, CEO von Curia. „Die neuen Anforderungen in Anhang 1 sind mit unserem proaktiven Ansatz zur Qualitätskontrolle vereinbar. Wir sind stets bestrebt, unseren Kunden ein Höchstmaß an Sicherheit in Bezug auf die Einhaltung von Vorschriften sowie unsere Fähigkeit zur Lieferung hochwertiger, steriler Wirkstoffe in großem Maßstab zu bieten. Unsere Kunden verlassen sich auf unsere Zuverlässigkeit, Präzision und Vertrauenswürdigkeit. Mit diesen Verbesserungen in Valladolid können sie darauf vertrauen, dass wir weiterhin vor den Branchentrends investieren werden, um gemeinsam mit ihnen ihre Produkte auf den Markt zu bringen.

Die Aktualisierungen in Valladolid erfolgten auf Basis einer unternehmensweiten Bewertung des globalen Curia–Netzwerks, mit der Verbesserungsmöglichkeiten im Zusammenhang mit den neuen Anforderungen des Anhangs 1 identifiziert wurden. Die Bewertung umfasste Verfahren, Ausrüstung, Versorgungsanlagen, Qualifikationen und Validierungen, um maßgeschneiderte Lösungen für jeden Standort zu entwickeln und Optimierungsmöglichkeiten zu ermitteln.

Seit mehr als 20 Jahren bedient das globale Netzwerk von Curia für die aseptische Verarbeitung von APIs ein breites Spektrum von Kunden weltweit. Dank dieser Investition ist das Unternehmen nun in der Lage, immer komplexere Fertigungsprojekte zu realisieren und gleichzeitig sein Engagement für die Bereitstellung lebensverändernder Medikamente in kompromissloser Qualität und Zuverlässigkeit zu verstärken.

Über Curia
Curia ist ein Auftragsforschungs–, Entwicklungs– und Produktionsunternehmen (CDMO) mit über 30 Jahren Erfahrung, einem integrierten Netzwerk von 20 Standorten weltweit und 3.200 Mitarbeitern, das mit Kunden aus der Biopharmazie zusammenarbeitet, um lebensverändernde Therapien auf den Markt zu bringen. Unser Angebot an niedermolekularen Wirkstoffen, generischen Wirkstoffen, sterilen Arzneimitteln und Biologika deckt den gesamten Prozess von der Entdeckung bis zur Vermarktung ab. Dazu gehören auch integrierte Kompetenzen in den Bereichen Zulassung, Analytik und sterile Abfüllung. Unsere Wissenschafts– und Prozessexperten sowie unsere Einrichtungen, die den behördlichen Vorschriften entsprechen, bieten erstklassige Kompetenz bei der Herstellung von Arzneimittelwirkstoffen und –produkten. Von der Neugier bis zur Heilung – wir unterstützen Sie bei jedem Schritt, um Ihre Forschung zu beschleunigen und das Leben von Patienten zu verbessern. Besuchen Sie uns unter curiaglobal.com.

Kontakt zum Unternehmen:
Viana Bhagan
Curia
+1 518 512 2111
[email protected]


GLOBENEWSWIRE (Distribution ID 9562221)

Curia investit 4 millions de dollars pour renforcer la fabrication stérile de substances actives (API)

ALBANY, New York, 27 oct. 2025 (GLOBE NEWSWIRE) — Curia Global, Inc. (Curia), l’une des principales organisations de recherche, de développement et de fabrication sous contrat, a annoncé aujourd’hui l’achèvement d’un investissement de 4 millions de dollars destiné à moderniser ses deux unités aseptiques de production de substances actives (API) à Valladolid, en Espagne. Cet investissement s’inscrit dans le cadre des dernières normes de l’annexe 1 des BPF de l’Union européenne (EU GMP Annex 1) et réaffirme l’engagement de longue date de Curia en matière d’excellence réglementaire et de qualité produit. L’annexe 1 fournit des orientations générales concernant la conception et le contrôle des installations, équipements, systèmes et procédures utilisés pour la fabrication de produits stériles. Elle applique les principes de la gestion des risques qualité (QRM) afin de prévenir toute contamination microbienne, particulaire ou endotoxinique des produits finis.

Ces améliorations soutiennent la modernisation des infrastructures et des technologies du site de Valladolid. Curia a eu recours à des outils innovants afin d’exploiter pleinement les opportunités offertes par une meilleure compréhension des procédés. La majeure partie de l’investissement a été consacrée à la modernisation des équipements du site, avec l’installation de nouveaux isolateurs et la mise à niveau des systèmes de ventilation (CVC), des panneaux pharmaceutiques, de l’automatisation, de la stérilisation in situ et des utilités générales. La transition vers un système entièrement fermé a été le principal moteur de ces améliorations, visant à renforcer la sécurité des procédés et des produits et à prévenir toute contamination microbiologique à chaque étape de la production. Par ailleurs, des améliorations ergonomiques pour les opérateurs ont été essentielles pour renforcer la sécurité opérationnelle, accompagnées de la mise en place de contrôles automatiques supplémentaires, conformes aux politiques plus strictes d’intégrité des données, telles que décrites dans le 21 CFR Part 11.

« La qualité et la conformité sont au cœur de notre fonctionnement », a déclaré Philip Macnabb, PDG de Curia. « Les nouvelles exigences de l’annexe 1 s’inscrivent dans notre approche proactive du contrôle qualité. » « Nous nous efforçons en permanence d’offrir à nos clients le plus haut niveau de garantie en matière de conformité, ainsi que notre capacité à fournir des substances actives stériles de haute qualité à grande échelle. » « Nos clients comptent sur nous pour notre fiabilité, notre rigueur et la confiance qu’ils peuvent nous accorder. » « Grâce à ces améliorations sur le site de Valladolid, nos clients peuvent être assurés que nous continuerons à investir en avance sur les tendances du secteur, tout en les accompagnant dans la mise sur le marché de leurs produits. »

Les améliorations apportées au site de Valladolid font suite à une évaluation menée à l’échelle mondiale au sein du réseau de Curia, afin d’identifier les opportunités d’optimisation en lien avec les nouvelles exigences de l’annexe 1. L’évaluation a porté sur les procédures, les équipements, les utilités, les qualifications et les validations, afin de concevoir des solutions adaptées à chaque site et de traiter toutes les opportunités d’optimisation.

Le réseau mondial de fabrication aseptique de substances actives (API) de Curia dessert un large portefeuille de clients à travers le monde depuis plus de 20 ans. Cet investissement permet à l’entreprise de soutenir des projets de fabrication de plus en plus complexes, tout en renforçant son engagement à fournir des médicaments capables de transformer la vie des patients, avec une qualité et une fiabilité sans compromis.

À propos de Curia
Curia est une organisation de recherche, de développement et de fabrication sous contrat (ou CDMO pour Contract Development and Manufacturing Organization) forte de plus de 30 ans d’expérience à son actif. Elle exploite un réseau intégré de plus de 20 sites à travers le monde et emploie quelque 3 200 collaborateurs travaillant en partenariat avec des clients biopharmaceutiques pour mettre sur le marché des traitements qui changent véritablement la vie. Nos offres en matière de petites molécules, d’API génériques et de produits biologiques couvrent le cycle complet de la découverte à la commercialisation, et intègrent des capacités réglementaires, analytiques et de remplissage et finition stériles. Nos experts en sciences et en processus, ainsi que nos installations conformes à la réglementation, offrent une expérience de premier ordre dans la fabrication de substances et de produits pharmaceutiques. De la curiosité au traitement, nous réalisons toutes les étapes permettant d’accélérer vos recherches et d’améliorer la vie des patients. Consultez notre site à l’adresse curiaglobal.com.

Contact de l’entreprise :
Viana Bhagan
Curia
+1 518 512 2111
[email protected]


GLOBENEWSWIRE (Distribution ID 9562221)

L'usine de médicaments stériles Curia nommée fabricant de l'année dans le Massachusetts

ALBANY, N.Y., 22 oct. 2025 (GLOBE NEWSWIRE) — Curia Global, Inc. (Curia), une organisation leader dans la recherche, le développement et la fabrication sous contrat, a annoncé aujourd'hui que son usine de produits pharmaceutiques stériles de Burlington, dans le Massachusetts, a été nommée « Fabricant de l'année » par le Massachusetts Legislative Manufacturing Caucus. Le prix a été remis lors de la 10e cérémonie annuelle de remise des prix de fabrication, qui s'est tenue le 21 octobre au stade Gillette.

Le site de Curia à Burlington fait partie du réseau de l’entreprise depuis 2010. L'installation est spécialisée dans la fabrication de produits pharmaceutiques sous forme de flacons et de seringues préremplies destinés aux études cliniques de stade avancé et aux produits commerciaux. Le site est reconnu pour ses capacités à gérer des procédés à base de solvants, des produits hautement visqueux et des substances réglementées. Il abrite également un laboratoire de mise au point des procédés sur site prenant en charge les études de mélange, la mise à l'échelle et la conception de formulations.

« Guidés par les normes de qualité les plus strictes, les employés de Curia jouent un rôle crucial dans la production de médicaments auxquels les patients peuvent faire confiance », a déclaré Mari–Kate Alter, directrice générale et chef de site de Curia Burlington. « Bien que nos clients directs soient des sociétés pharmaceutiques, nous venons travailler chaque jour en pensant aux patients. Nous sommes honorés de contribuer à l’amélioration de la vie des patients et sommes fiers d’être reconnus pour notre rôle dans l’écosystème de fabrication du Massachusetts. »

Les capacités de Curia en matière de produits pharmaceutiques stériles comprennent le travail avec des API complexes, des composés puissants et cytotoxiques, des formulations hautement visqueuses et des substances réglementées, de l'échelle clinique à l'échelle commerciale, dans quatre installations de pointe à travers le monde. Le site de Burlington fait partie du réseau mondial d'installations de remplissage et de finition stériles de Curia, qui comprend la fabrication clinique à Camarillo, en Californie et à Glasgow, au Royaume–Uni, ainsi que des capacités commerciales et cliniques à Albuquerque, au Nouveau–Mexique.

Le Manufacturing Caucus, formé en 2014, comprend plus de 70 législateurs du Massachusetts qui se concentrent sur le renforcement du secteur manufacturier de l'État par le biais de la formation de la main–d'œuvre, du soutien à l'innovation et des programmes d'apprentissage.

« C'est une période passionnante pour les fabricants engagés comme Curia qui incarnent le 'Making It in Massachusetts' », a confié le représentant de l'État Jeffrey Roy, président du caucus manufacturier de la Chambre. « L’industrie manufacturière reste essentielle à notre économie et à notre avenir, offrant innovation et emplois bien rémunérés aux résidents de tout le Commonwealth. Nous sommes impatients de célébrer Curia lors de la 10e cérémonie annuelle de remise des prix de fabrication au stade Gillette, le mardi 21 octobre 2025. »

À propos de Curia
Curia est une organisation de recherche, de développement et de fabrication sous contrat (ou CDMO pour Contract Development and Manufacturing Organization) forte de plus de 30 ans d’expérience à son actif. Elle exploite un réseau intégré de plus de 20 sites à travers le monde et emploie quelque 3 200 collaborateurs travaillant en partenariat avec des clients biopharmaceutiques pour mettre sur le marché des traitements qui changent véritablement la vie des gens. Nos offres en matière de petites molécules, d’API génériques et de produits biologiques couvrent le cycle complet de la découverte à la commercialisation, et intègrent des capacités réglementaires, analytiques et de remplissage et finition stériles. Nos experts en sciences et en processus, ainsi que nos installations conformes à la réglementation, offrent une expérience de premier ordre dans la fabrication de substances et de produits pharmaceutiques. De la curiosité au traitement, nous réalisons toutes les étapes permettant d’accélérer vos recherches et d’améliorer la vie des patients. Consultez notre site à l’adresse curiaglobal.com.

Contact de l’entreprise :
Viana Bhagan
Curia
+1 518 512 2111
[email protected]


GLOBENEWSWIRE (Distribution ID 9550232)

Curias Anlage für sterile Arzneimittel als Hersteller des Jahres in Massachusetts ausgezeichnet

ALBANY, N.Y., Oct. 22, 2025 (GLOBE NEWSWIRE) — Curia Global, Inc. (Curia), ein führendes Auftragsforschungs–, Entwicklungs– und Produktionsunternehmen, gab heute bekannt, dass seine Anlage für sterile Arzneimittel in Burlington, Massachusetts, vom Massachusetts Legislative Manufacturing Caucus zum „Hersteller des Jahres” gekürt wurde. Die Auszeichnung wurde im Rahmen der 10. jährlichen Manufacturing Awards Ceremony verliehen, die am 21. Oktober im Gillette Stadium stattfand.

Der Standort Burlington von Curia gehört seit 2010 zum Netzwerk des Unternehmens. Die Anlage ist auf die Herstellung von Arzneimitteln in Fläschchen und Fertigspritzen für klinische Studien in der Spätphase und kommerzielle Produkte spezialisiert. Der Standort ist bekannt für sein Know–how in Bezug auf lösungsmittelbasierte Prozesse, hochviskose Formulierungen und kontrollierte Substanzen. Er beherbergt außerdem ein eigenes Prozessentwicklungslabor, das Mischstudien, Scale–up und Formulierungsentwicklung unterstützt.

„Die Mitarbeiter von Curia spielen eine entscheidende Rolle bei der Herstellung von Arzneimitteln, denen Patienten vertrauen können, und orientieren sich dabei an strengsten Qualitätsstandards“, so Mari–Kate Alter, Geschäftsführerin und Standortleiterin von Curia Burlington. „Obwohl unsere direkten Kunden Pharmaunternehmen sind, kommen wir jeden Tag mit den Patienten im Hinterkopf zur Arbeit. Wir fühlen uns geehrt, zur Verbesserung der Lebensqualität von Patienten beitragen zu dürfen, und sind stolz darauf, für unsere Rolle im Fertigungsökosystem von Massachusetts anerkannt zu werden.“

Die Kompetenzen von Curia im Bereich steriler Arzneimittel umfassen die Arbeit mit komplexen Wirkstoffen, hochwirksamen und zytotoxischen Verbindungen, hochviskosen Formulierungen und kontrollierten Substanzen, vom klinischen bis zum kommerziellen Maßstab, in vier hochmodernen Einrichtungen weltweit. Der Standort Burlington ist Teil des globalen Netzwerks steriler Abfüllanlagen von Curia, zu dem auch die klinische Produktion in Camarillo (Kalifornien) und Glasgow (Großbritannien) sowie kommerzielle und klinische Kapazitäten in Albuquerque (New Mexico) gehören.

Der 2014 gegründete Manufacturing Caucus umfasst mehr als 70 Gesetzgeber aus Massachusetts, die sich auf die Stärkung des Fertigungssektors des Bundesstaates durch Personalschulungen, Innovationsförderung und Ausbildungsprogramme konzentrieren.

„Dies ist eine spannende Zeit für engagierte Hersteller wie Curia, die das Motto ‚Making It in Massachusetts‘ verkörpern“, so Jeffrey Roy, State Representative und House Chair, Manufacturing Caucus. „Die Fertigungsindustrie ist für unsere Wirtschaft und Zukunft nach wie vor von entscheidender Bedeutung, da sie Innovationen fördert und hochbezahlte Arbeitsplätze für die Einwohner des gesamten Bundesstaates schafft. Wir freuen uns darauf, Curia bei der 10. jährlichen Manufacturing Awards Ceremony am Dienstag, dem 21. Oktober 2025, im Gillette Stadium zu feiern.“

Über Curia
Curia ist ein Auftragsforschungs–, Entwicklungs– und Produktionsunternehmen (CDMO) mit über 30 Jahren Erfahrung, einem integrierten Netzwerk von 20 Standorten weltweit und 3.200 Mitarbeitern, das mit Kunden aus der Biopharmazie zusammenarbeitet, um lebensverändernde Therapien auf den Markt zu bringen. Unser Angebot an niedermolekularen Wirkstoffen, generischen Wirkstoffen, sterilen Arzneimitteln und Biologika umfasst die gesamte Bandbreite von der Entdeckung bis zur Vermarktung, einschließlich integrierter Kompetenzen in den Bereichen Zulassung, Analytik und sterile Abfüllung. Unsere Wissenschafts– und Prozessexperten sowie unsere behördlichen Vorschriften entsprechenden Einrichtungen bieten erstklassige Kompetenz in der Herstellung von Arzneimittelwirkstoffen und –produkten. Von der Neugier bis zur Heilung – wir unterstützen Sie bei jedem Schritt, um Ihre Forschung zu beschleunigen und das Leben von Patienten zu verbessern. Besuchen Sie uns unter curiaglobal.com.

Kontakt zum Unternehmen:
Viana Bhagan
Curia
+1 518 512 2111
[email protected]


GLOBENEWSWIRE (Distribution ID 9550232)

Instalação de Medicamentos Estéreis da Curia Nomeada Fabricante do Ano de Massachusetts

ALBANY, N.Y., Oct. 22, 2025 (GLOBE NEWSWIRE) — A Curia Global, Inc. (Curia), uma organização líder em contratos de pesquisa, desenvolvimento e fabricação, anunciou hoje que sua instalação de medicamentos estéreis em Burlington, MA, foi nomeada “Fabricante do Ano” pelo Comitê de Fabricação Legislativa de Massachusetts. O prêmio foi entregue na 10ª Cerimônia Anual de Premiação de Fabricação, realizada no dia 21 de outubro no Gillette Stadium.

A unidade de Burlington da Curia faz parte da rede da empresa desde 2010. A instalação é especializada na fabricação de produtos farmacêuticos de frascos e seringas pré–cheias para ensaios clínicos em estágio avançado e produtos comerciais. A unidade é conhecida por sua capacidade de lidar com processos à base de solventes, produtos altamente viscosos e substâncias controladas. Também abriga um laboratório de desenvolvimento de processos no local, apoiando estudos de mistura, aumento de escala e desenvolvimento de formulações.

“Os funcionários da Curia têm um papel crucial na produção de medicamentos em que os pacientes podem confiar, guiados pelos mais rigorosos padrões de qualidade”, disse Mari–Kate Alter, Gerente Geral e Chefe de Unidade da Curia Burlington. “Embora nossos clientes diretos sejam empresas farmacêuticas, trabalhamos todos os dias pensando nos pacientes. Nos sentimos honrados em contribuir para melhorar a vida dos pacientes e temos orgulho de ser reconhecidos pelo nosso papel no ecossistema de fabricação de Massachusetts.”

A fabricação de medicamentos estéreis da Curia inclui o trabalho com APIs complexos, compostos potentes e citotóxicos, formulações altamente viscosas e substâncias controladas, de escala clínica a comercial, realizados em quatro instalações avançadas em todo o mundo. A unidade de Burlington faz parte da rede global de instalações de processamento final estéril da Curia, que inclui fabricação clínica em Camarillo, CA e Glasgow, Reino Unido, bem como capacidades comerciais e clínicas em Albuquerque, NM.

O Comitê de Manufatura, criado em 2014, inclui mais de 70 legisladores de Massachusetts focados no fortalecimento do setor manufatureiro do estado por meio de treinamento da força de trabalho, apoio à inovação e programas de aprendizagem.

“Este é um momento empolgante para fabricantes comprometidos como a Curia, que incorpora o ‘Making It in Massachusetts’”, disse o representante estadual Jeffrey Roy, Presidente do Comitê de Manufatura. “A manufatura continua sendo vital para nossa economia e para o futuro, proporcionando inovação e empregos bem remunerados para residentes em toda a Commonwealth. Estamos prontos para celebrar a Curia na 10ª Cerimônia Anual de Premiação de Fabricação no Gillette Stadium na terça–feira, 21 de outubro de 2025.”

Sobre a Curia
A Curia é uma Organização de Desenvolvimento e Fabricação por Contratos (CDMO) com mais de 30 anos de experiência, uma rede integrada de 20 locais em todo o mundo e 3.200 funcionários em parcerias com clientes biofarmacêuticos para lançamento no mercado terapias que mudam a vida. Nossas ofertas de pequenas moléculas, APIs genéricos, produtos de medicamentos estéreis e produtos biológicos resultam em descobertas através da comercialização, com integridade regulatória, de capacidade analítica e processamento final estéril. Nossos especialistas científicos e de processos, juntamente com nossas instalações em conformidade regulatórias, oferecem a melhor experiência em fabricação de medicamentos e produtos farmacêuticos. Da curiosidade à cura, proporcionamos todas as etapas necessárias para acelerar sua pesquisa e melhorar a vida dos pacientes. Visite–nos em curiaglobal.com.

Contato Corporativo:
Viana Bhagan
Curia
+1 (518) 512 2111
[email protected]


GLOBENEWSWIRE (Distribution ID 9550232)

Curia Sterile Drug Product Facility Named Massachusetts Manufacturer of the Year

ALBANY, N.Y., Oct. 21, 2025 (GLOBE NEWSWIRE) — Curia Global, Inc. (Curia), a leading contract research, development and manufacturing organization, today announced its Burlington, MA sterile drug product facility has been named “Manufacturer of the Year” by the Massachusetts Legislative Manufacturing Caucus. The award was presented at the 10th Annual Manufacturing Awards Ceremony, held on Oct. 21 at Gillette Stadium.

Curia’s Burlington site has been part of the company’s network since 2010. The facility specializes in drug product manufacturing of vials and prefilled syringes for late–stage clinical trials and commercial products. The site is known for its capabilities to handle solvent–based processes, highly viscous products and controlled substances. It also houses an on–site process development lab supporting mixing studies, scale–up and formulation development.

“Curia employees play a crucial role in producing medicines patients can trust, guided by the most stringent quality standards,” said Mari–Kate Alter, General Manager and Site Head, Curia Burlington. “While our direct clients are pharmaceutical companies, we come to work each day with patients in mind. We are honored to contribute to improving patient lives and are proud to be recognized for our role in Massachusetts’ manufacturing ecosystem.”

Curia’s sterile drug product capabilities include working with complex APIs, potent and cytotoxic compounds, highly viscous formulations and controlled substances, from clinical to commercial scale, at four advanced facilities around the world. The Burlington site is part of Curia’s global network of sterile fill–finish facilities, which includes clinical manufacturing in Camarillo, CA and Glasgow, UK, as well as commercial and clinical capabilities in Albuquerque, NM.

The Manufacturing Caucus, formed in 2014, includes more than 70 Massachusetts legislators focused on strengthening the state’s manufacturing sector through workforce training, innovation support and apprenticeship programs.

“This is an exciting time for committed manufacturers like Curia who embody ‘Making It in Massachusetts,’” said State Representative Jeffrey Roy, House Chair of the Manufacturing Caucus. “Manufacturing remains vital to our economy and future, providing innovation and high–paying jobs for residents across the Commonwealth. We look forward to celebrating Curia at the 10th Annual Manufacturing Awards Ceremony at Gillette Stadium on Tuesday, Oct. 21, 2025.”

About Curia
Curia is a contract research, development and manufacturing organization (CDMO) with over 30 years of experience, an integrated network of 20 global sites and 3,200 employees partnering with biopharmaceutical customers to bring life–changing therapies to market. Our offerings in small molecule, generic APIs, sterile drug product and biologics span discovery through commercialization, with integrated regulatory, analytical and sterile fill–finish capabilities. Our scientific and process experts, along with our regulatory–compliant facilities, provide a best–in–class experience across drug substance and drug product manufacturing. From curiosity to cure, we deliver every step to accelerate your research and improve patients’ lives. Visit us at curiaglobal.com.

Corporate Contact:
Viana Bhagan
Curia
+1 518 512 2111
[email protected]


GLOBENEWSWIRE (Distribution ID 9549347)

Minovia Therapeutics Receives FDA Orphan Drug Designation for MNV-201 in Myelodysplastic Syndrome

HAIFA, Israel, Oct. 15, 2025 (GLOBE NEWSWIRE) — Minovia Therapeutics Ltd. (“Minovia” or the “Company”), a clinical–stage biotechnology company developing novel therapies to treat mitochondrial diseases and combat age–related decline, announces that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to the Company’s lead investigational compound, MNV–201 for Myelodysplastic Syndrome (MDS), a serious age–related hematopoietic disease. This designation is in addition to the existing FDA Fast Track Designation in MDS, as well as both Fast Track and Rare Pediatric Disease Designations for MNV–201 in the treatment of Pearson Syndrome.

“We continue to receive validation from the FDA for the potential of our lead product, MNV–201, this time in the form of Orphan Drug Designation in MDS. MNV–201 targets the mitochondria, a critical multi–functional organelle. FDA designations such as ODD underscore the urgency of drugs treating these diseases affecting smaller populations, while providing additional benefits across the FDA process that, we expect, will prove both medically and financially valuable,” said Minovia Co–founder and CEO, Natalie Yivgi–Ohana, Ph.D.

“Orphan drug designation for MNV–201 marks an important milestone in our mission to address critical challenges in mitochondrial health in both primary and acquired mitochondrial diseases. By leveraging our expertise in mitochondrial and hematopoietic science, and through the innovative mechanism of action of our drug product, we hope to bring forward a treatment option that could significantly improve outcomes for MDS patients,” added Minovia Chief Scientific Officer, Noa Sher, PhD.

Orphan drug designation is a status granted by the FDA to drugs developed to treat rare diseases affecting fewer than 200,000 people in the U.S. This designation provides various incentives, such as tax credits and market exclusivity, to encourage the development of treatments for conditions that may not be profitable otherwise.

The Company also announced entry into a definitive business combination agreement (the “Business Combination Agreement”) with Launch One Acquisition Corp. (Nasdaq: LPAA, “Launch One”), a publicly traded special purpose acquisition company. Following the expected closing of the transaction contemplated by this Business Combination Agreement (the “Business Combination”), projected for late 2025, the combined company will operate as Minovia Therapeutics and trade on Nasdaq under a new ticker symbol.

About MDS

MDS is defined by ineffective hematopoiesis resulting in blood cytopenia, and clonal instability with a risk of evolution to Acute Myeloid Leukemia (AML). Patients with MDS collectively have a high symptom burden and are also at risk of death from complications of cytopenia and AML. The goals of therapy for patients with MDS are to improve cytopenia, reduce disease–associated symptoms and the risk of disease progression and death, thereby improving both quality of life and lifespan. The median age at diagnosis of MDS is ~70 years, but surprisingly some of the Pearson Syndrome patients develop MDS in a much higher prevalence relative to the disease population. About 15% of the MDS patients will present with Sideroblastic Anemia, the most common symptom in Pearson Syndrome. Minovia developed novel blood biomarkers to measure mitochondrial health and has been able to demonstrate for the first time that MDS is presumably an age–related mitochondrial disease. As such, Minovia is currently conducting a Phase Ib study of MNV–201 in low–risk MDS patients. Six out of the nine expected patients in the study have been dosed so far.

About MNV–201

MNV–201 is a first–in–class cell therapy that uses Minovia’s proprietary Mitochondrial Augmentation Technology (MAT) to add healthy, energy–producing mitochondria into a patient’s own stem cells — aiming to restore organ function and improve health. In early–stage clinical studies, MAT has demonstrated a strong safety profile and signs of multi–system benefit in patients with Pearson Syndrome, including improvements in growth, muscle function, hematologic stability, and improved quality of life.

About Minovia Therapeutics

Minovia Therapeutics, chaired by John Cox, is a clinical–state biotechnology company working on treatments to replace dead or defective mitochondria with new healthy mitochondria, helping people with mitochondrial diseases and fighting aging. Minovia’s main treatment, MNV–201, is already being tested for Pearson Syndrome and Myelodysplastic Syndrome. Minovia is also developing ways to help people live longer, healthier lives. Based in Haifa, Israel, where it operates a GMP facility for mitochondrial drug substance and drug product manufacturing for clinical trials related to its therapy, Minovia is planning to expand operations to the U.S. For more information, visit www.minoviatx.com.

About Launch One Acquisition Corp.

Launch One Acquisition Corp. is a company set up to merge with and take public an exciting business in healthcare or technology. Listed on Nasdaq under the ticker LPAA, Launch One is led by experienced leaders who want to support game–changing solutions. For more information, contact Jurgen van de Vyver at [email protected].

Additional Information and Where to Find It

In connection with the Business Combination and the Business Combination Agreement, among Launch One, Minovia and Mito US One Ltd., a newly formed Israeli company limited by shares (“Pubco”), and certain other parties named therein. Launch One and Minovia intend to file relevant materials with the U.S. Securities and Exchange Commission (“SEC”), including a Registration Statement on Form F–4 of Pubco (the “Registration Statement”), which will include a proxy statement/prospectus of Launch One, and will file other documents regarding the proposed Business Combination with the SEC. This communication is not intended to be, and is not, a substitute for the proxy statement/prospectus or any other document that Launch One has filed or may file with the SEC in connection with the proposed Business Combination. The Registration Statement has not been filed or declared effective by the SEC. Following such filing and upon such declaration of effectiveness, the definitive proxy statement/prospectus contained within the Registration Statement and other relevant materials for the proposed Business Combination will be mailed or made available to stockholders of Launch One as of a record date to be established for voting on the proposed Business Combination.

Before making any voting or investment decision, investors and stockholders of Launch One are urged to carefully read, when they become available, the entire Registration Statement, the proxy statement/prospectus, and any other relevant documents filed with the SEC, as well as any amendments or supplements to these documents, and the documents incorporated by reference therein, because they will contain important information about Launch One, Minovia, Pubco and the proposed Business Combination . Launch One’s investors and stockholders and other interested persons will also be able to obtain copies of the Registration Statement, the preliminary proxy statement/prospectus, the definitive proxy statement/prospectus, other documents filed with the SEC that will be incorporated by reference therein, and all other relevant documents filed with the SEC by Launch One and/or Pubco in connection with the Business Combination, without charge, once available, at the SEC’s website at www.sec.gov, or by directing a request to Launch One or Minovia at the addresses set forth below.

Participants In the Solicitation

Launch One, Minovia, Pubco and their respective directors, executive officers, other members of management and employees may be deemed participants in the solicitation of proxies from Launch One’s stockholders with respect to the Business Combination. Investors and security holders may obtain more detailed information regarding the names, and interests in the Business Combination, of Launch One’s directors and officers in Pubco's and Launch One’s filings with the SEC, including, when filed with the SEC, the preliminary proxy statement/prospectus, the definitive proxy statement/prospectus, amendments and supplements thereto, and other documents filed with the SEC. Such information with respect to Minovia’s directors and executive officers will also be included in the proxy statement/prospectus. You may obtain free copies of these documents as described above under the heading “Additional Information and Where to Find It.”

Non–Solicitation

This press release is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect of the potential transaction and shall not constitute an offer to sell or a solicitation of an offer to buy the securities of Launch One, Pubco, or Minovia, nor shall there be any sale of any such securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of the Securities Act of 1933, as amended.

Forward–Looking Statements

This press release includes certain statements that may be considered forward–looking statements within the meaning of the federal securities laws. Forward–looking statements include, without limitation, statements about future events or Minovia’s, Launch One's, or Pubco's future financial or operating performance. For example, statements regarding the development and regulatory approval of MNV–201, the implications of Fast Track Designation, RPD and PRVs and the timing of future clinical trials or potential applications are forward–looking statements. In some cases, you can identify forward–looking statements by terminology such as “may,” “should,” “could,” “might,” “plan,” “possible,” “project,” “strive,” “budget,” “forecast,” “expect,” “intend,” “will,” “estimate,” “anticipate,” “believe,” “predict,” “potential” or “continue,” or the negatives of these terms or variations of them or similar terminology.

These forward–looking statements regarding future events and the future results of Minovia or Launch One are based on current expectations, estimates, forecasts, and projections about the industry in which Minovia or Launch One operates, as well as the beliefs and assumptions of Minovia’s and Launch One's management. These forward–looking statements are only predictions and are subject to, without limitation, (i) known and unknown risks, including the risks and uncertainties indicated from time to time in the final prospectus of Launch One relating to its initial public offering filed with the SEC, including those under “Risk Factors” therein, and other documents filed or to be filed with the SEC by Launch One or Pubco; (ii) uncertainties; (iii) assumptions; and (v) other factors beyond Minovia’s or Launch One's control that are difficult to predict because they relate to events and depend on circumstances that will occur in the future. They are neither statements of historical fact nor promises or guarantees of future performance. Therefore, Minovia’s actual results may differ materially and adversely from those expressed or implied in any forward–looking statements and Minovia and Launch One therefore caution against relying on any of these forward–looking statements.

These forward–looking statements are based upon estimates and assumptions that, while considered reasonable by Minovia and its management, as the case may be, are inherently uncertain and are inherently subject to risks, variability and contingencies, many of which are beyond Minovia’s or Launch One's control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (i) the occurrence of any event, change or other circumstances that could give rise to the termination of the Business Combination Agreement and any subsequent definitive agreements with respect to the Business Combination; (ii) the outcome of any legal proceedings that may be instituted against Launch One, Minovia, Pubco, or others following the announcement of the Business Combination and any definitive agreements with respect thereto; (iii) the inability to complete the Business Combination due to the failure to obtain consents and approvals of the shareholders of Launch One and Minovia, to obtain financing to complete the Business Combination or to satisfy other conditions to closing, or delays in obtaining, adverse conditions contained in, or the inability to obtain necessary regulatory approvals required to complete the transactions contemplated by the Business Combination Agreement; (iv) changes to the proposed structure of the Business Combination that may be required or appropriate as a result of applicable laws or regulations or as a condition to obtaining regulatory approval of the Business Combination; (v) projections, estimates and forecasts of revenue and other financial and performance metrics, projections of market opportunity and expectations, and the estimated implied enterprise value of Minovia; (vi) Minovia’s ability to scale and grow its business, and the advantages and expected growth of Minovia; (vii) Minovia’s ability to source and retain talent, and the cash position of Minovia following closing of the Business Combination; (viii) the ability to meet stock exchange listing standards in connection with, and following, the consummation of the Business Combination; (ix) the risk that the Business Combination disrupts current plans and operations of Minovia as a result of the announcement and consummation of the Business Combination; (x) the ability to recognize the anticipated benefits of the Business Combination, which may be affected by, among other things, competition, the ability of Minovia to grow and manage growth profitably, maintain key relationships and retain its management and key employees; (xi) costs related to the Business Combination; (xii) changes in applicable laws, regulations, political and economic developments; (xiii) the possibility that Minovia may be adversely affected by other economic, business and/or competitive factors; (xiv) Minovia’s estimates of expenses and profitability; (xv) the failure to realize estimated shareholder redemptions, purchase price and other adjustments; and (xvi) other risks and uncertainties set forth in the filings by Launch One and Minovia with the SEC. There may be additional risks that neither Launch One nor Minovia presently know or that Launch One and Minovia currently believe are immaterial that could also cause actual results to differ from those contained in the forward–looking statements. Any forward–looking statements made by or on behalf of Launch One or Minovia speak only as of the date they are made. Neither Launch One nor Minovia undertakes any obligation to update any forward–looking statements to reflect any changes in their respective expectations with regard thereto or any changes in events, conditions or circumstances on which any such statements are based.

Contact

Minovia Therapeutics Ltd.
Natalie Yivgi Ohana, Co–Founder and CEO
+972–74–7039954
[email protected]

Launch One Acquisition Corp.
Jurgen van de Vyver
[email protected]
+1–510–692–9600

Investor Relations
Dave Gentry, CEO
RedChip Companies
+1–407–644–4256
[email protected]

Investor Relations
Jules Abraham
Managing Director, Communications
CORE IR
1–212–655–0924
[email protected]


GLOBENEWSWIRE (Distribution ID 9544499)