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Healthcare Innovation Summit Africa Returns to Johannesburg – Registration Now Open

JOHANNESBURG, South Africa, Aug. 14, 2025 (GLOBE NEWSWIRE) — The Healthcare Innovation Summit Africa (HISA) 2025, Africa’s leading platform for exploring the latest trends and technologies shaping the healthcare industry, will return to Johannesburg on 22 – 23 October 2025 for its 10th annual edition. Organised by IT News Africa, the event will gather senior healthcare professionals, government leaders, innovators, and technology providers from across Africa and beyond.

Themed “Connected Care, Smarter Systems: Building a Digitally Resilient African Health Ecosystem,” HISA 2025 will feature a robust agenda that covers critical areas such as artificial intelligence (AI), the Internet of Things (IoT), robotics, telemedicine, big data analytics, and digital transformation strategies for both public and private healthcare sectors.

Confirmed keynote and panel speakers include:

  • Dr Richard Friedland, Group CEO, Netcare
  • Dr. Boris Konrad, Neuroscientist, AI and Memory Expert, Radboudumc (Germany)
  • Andrew Raynes, CIO & SIRO, Royal Papworth Hospital (UK)
  • Nhlanhla Xaba, ICT Manager: Governance & Information Management, Mediclinic
  • Rajeev Eashwari, President, South African Health Informatics Association
  • Taryn Lotz, Head of IT, Aspen Pharmacare
  • Craig Killeen, CEO, Medinformer
  • Joost Pielage, CTO, Quro Medical
  • Quantin van Rensburg, CIO, Platinum Health Medical Scheme
  • Ish Hendricks, CEO, Netclinic

With Africa’s healthcare industry undergoing rapid transformation, HISA 2025 offers a unique opportunity for stakeholders to gain actionable insights and forge meaningful partnerships.

Delegates will benefit from:

  • Visionary keynote presentations from local and international thought leaders
  • Expert–led panel discussions tackling pressing healthcare challenges and opportunities
  • Exhibition showcases of innovative solutions, products, and services
  • Networking opportunities with policymakers, industry leaders, and innovators

Click here to register now

“HISA 2025 is not just a conference, it is where the future of African healthcare takes shape,” said the event organisers. “The event provides a powerful platform for collaboration, innovation, and the exchange of ideas that can positively impact healthcare systems across the continent.”

Event Details:
Date: 22 – 23 October 2025
Venue: Gallagher Convention Centre, Johannesburg, South Africa
Event Website: www.healthcareinnovationsummit.co.za

About HISA
The Healthcare Innovation Summit Africa is an annual gathering of healthcare professionals, innovators, and policymakers dedicated to exploring and implementing technology–driven solutions that improve healthcare delivery across Africa.


GLOBENEWSWIRE (Distribution ID 1001122873)

Entera Bio Receives FDA Agreement on BMD as Primary Endpoint for EB613 Registrational, Phase 3 Study in Post-Menopausal Women with Osteoporosis

JERUSALEM, July 28, 2025 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of oral peptides and protein replacement therapies, announced today that in a written response to a Type A meeting request, the U.S. Food and Drug Administration (FDA) agreed with the Company’s proposal that the NDA marketing application filing for EB613 would be supported by a single multinational, randomized, double–blind, placebo–controlled, 24 month phase 3 study in women with postmenopausal osteoporosis, where change in total hip BMD is evaluated as the primary endpoint, and incidence of new or worsening vertebral fractures is evaluated as the key secondary endpoint. This marks a shift from precedent placebo–controlled phase 3 studies of new osteoporosis drugs which required incidence of fracture as the primary endpoint.

“This regulatory update is a major milestone for Entera and the entire osteoporosis community,” said Miranda Toledano, CEO of Entera. “Our alignment with the FDA reflects the strength of our data and collaborative discussions. Importantly, it allows us to advance our clinical development program without having to wait for FDA’s qualification of the Study to Advance Bone Mineral Density as a Regulatory Endpoint (SABRE), which is still expected this year. We thank the FDA and the Review Team at the Division of Endocrinology for their constructive approach. We also thank the SABRE team for paving the path to innovation for osteoporosis treatment,” said Toledano.

“Osteoporosis afflicts more women than heart attack, stroke and breast cancer combined. Over 200 million women globally are estimated to have osteoporosis and remain vastly undertreated, despite efficacious injectable anabolic (bone forming) treatments. One in two women over the age of 50 will suffer a fracture due to osteoporosis. No new drug for osteoporosis has been approved by FDA since 2019; and innovation has stalled for close to a decade due to the size, duration, cost and ethical constraints associated with fracture endpoint studies. In a silent disease, patient and clinician access to novel and alternative forms of validated mechanisms of action is important. We are developing EB613 as the first oral, once–daily anabolic tablet treatment to potentially serve this unmet medical need. EB613 is intended to increase skeletal mass, improve bone microarchitecture and reduce the risk of fracture,” said Miranda Toledano, CEO of Entera.

About EB613

Substantial evidence supports the efficacy of anabolic therapies over bisphosphonates for lowering fracture risk in osteoporosis patients at high risk. However, all available anabolic therapies are administered by subcutaneous (SC) injection and used in a minority of eligible patients. EB613 (oral PTH (1–34), teriparatide), is being developed as the first oral, once–daily anabolic tablet treatment for osteoporosis. EB613 completed a phase 2, 6–month, 161–patient, placebo–controlled study that met all biomarker and BMD endpoints without significant safety concerns in women with postmenopausal osteoporosis or low BMD (JBMR 2024). EB613 produced rapid dose–proportional increases in biochemical markers of bone formation, reductions in markers of bone resorption, and increased lumbar spine, total hip, and femoral neck BMD. The effects of EB613 on trabecular and cortical bone using 3D–DXA showed increases with EB613 compared with placebo in a variety of indices, including integral volumetric BMD and trabecular volumetric BMD, cortical thickness, and cortical surface BMD. Mechanistically, the findings suggest that bone strengthening, and fracture resistance may occur rapidly with EB613. Furthermore, the data are consistent with those of published subcutaneous teriparatide at the 6–month time point. Further abstracts have been submitted to ASBMR and NAMS 2025 conferences.

About Entera Bio

Entera is a clinical stage company focused on developing oral peptide and protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages on a disruptive and proprietary technology platform (N–Tab™) and its pipeline of first–in–class oral peptide programs targeting PTH(1–34), GLP–1 and GLP–2. The Company’s most advanced product candidate, EB613 (oral PTH(1–34), teriparatide), is being developed as the first oral, osteoanabolic (bone building) once–daily tablet treatment for post–menopausal women with low BMD and high–risk osteoporosis. A placebo–controlled, dose–ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). The EB612 program is being developed as the first oral PTH(1–34) tablet peptide replacement therapy for hypoparathyroidism. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity and metabolic syndromes; and first oral GLP–2 peptide as an injection–free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. For more information on Entera Bio, visit www.enterabio.com or follow us on LinkedIn, Twitter, Facebook, Instagram.

About SABRE

The Study to Advance BMD as a Regulatory Endpoint (SABRE) initiative, which started as a public private partnership sponsored by the FNIH in 2013, has amassed the strongest evidence to date that treatment–related gains in Bone Mineral Density (BMD) reliably and quantitatively predict fracture–risk reduction. In November 2023, the SABRE team submitted a full qualification package to FDA’s Biomarker Division as part of the Drug Development Tool Biomarker Qualification Pathway to potentially qualify BMD as a surrogate endpoint to fracture; in March 2024, the FDA Biomarker Division indicated to the SABRE project team that a decision would be issued within 10 months. The single most important predictor of osteoporotic fractures in postmenopausal women without a previous fracture is BMD. Treatment guidelines in the U.S. strongly recommend pharmacologic therapy for patients with a BMD T–score of –2.5 or lower in the spine, femoral neck, total hip. SABRE final FQP meta–analysis included data from 22 randomized, placebo–controlled trials (63,000 participants across seven drug classes) and showed that treatment–related gains in total–hip BMD explain 72% of the observed fracture–risk reduction. The R2 for this correlation was 0.73—double the correlation between blood pressure and stroke (R² = 0.37), which is the well accepted basis for the value of antihypertensive therapy.

Cautionary Statement Regarding Forward Looking Statements

Various statements in this presentation are “forward–looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this presentation regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward–looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward–looking statements. Forward–looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward–looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved.

Important factors that could cause actual results to differ materially from those reflected in Entera’s forward–looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA’s interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera’s product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera’s ability to establish and maintain development and commercialization collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s competitive position with respect to other products on the market or in development for the treatment of osteoporosis, hypoparathyroidism, short bowel syndrome, obesity, metabolic conditions and other disease categories it pursues; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s ability to obtain and maintain regulatory approval for any of its product candidates; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera’s intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Cautionary Statement Regarding Forward–Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s most recent Annual Report on Form 10–K filed with the SEC, as well as Entera’s subsequently filed Quarterly Reports on Form 10–Q and Current Reports on Form 8–K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward–looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward–looking statements Entera makes in this presentation. The information in this presentation is provided only as of the date of this presentation, and Entera undertakes no obligation to update or revise publicly any forward–looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.


GLOBENEWSWIRE (Distribution ID 9501141)

EAACI-Führung blickt auf rekordverdächtigen Kongress 2025 zurück: Ein entscheidender Moment für Allergologie und Immunologie

ZÜRICH, July 17, 2025 (GLOBE NEWSWIRE) — Mit über 7.600 Teilnehmern hat der EAACI–Kongress 2025 nicht nur aufgrund seiner Größe Schlagzeilen gemacht, sondern auch aufgrund der eindringlichen Botschaft seiner Führungskräfte. Nun, einen Monat nach Abschluss des Kongresses in Glasgow, teilen die führenden Vertreter der EAACI ihre Überlegungen zu diesem, wie sie es bezeichnen, Wendepunkt für den Bereich mit. Die Veranstaltung fand vom 13. bis 16. Juni im Scottish Event Campus statt und stand unter dem Motto: „Grenzen überwinden in Allergie, Asthma und klinischer Immunologie: Integration der globalen Gesundheit für eine nachhaltige Zukunft“.

„Der diesjährige Kongress war ein Wendepunkt“, so Prof. Maria Torres, Präsidentin der EAACI. „Wir treten in eine Ära ein, in der wissenschaftliche Innovation, Gleichberechtigung in der Gesundheitsversorgung und Umweltgesundheit gemeinsam vorangetrieben werden müssen.“

Das Programm umfasste über 250 Stunden Vorträge, Workshops und Symposien zu bahnbrechenden Fortschritten in den Bereichen Arzneimittelallergien, T2–Entzündungen, Asthma bei Kindern und hereditäres Angioödem. Das Präsidialsymposium befasste sich mit Antibiotikaresistenzen aus der Perspektive von „One Health“, während eine aktuelle Sitzung zu Klimawandel und Insektenallergien die weltweite Aufmerksamkeit auf die ökologischen Auswirkungen auf die Patientenversorgung lenkte.

Weit über die Mauern des SEC hinaus hat der EAACI–Kongress 2025 die gesamte Stadt mit Initiativen belebt, die die Wissenschaft auf die Straße gebracht haben. Das Clinical Village im Glasgow Science Centre empfing die Öffentlichkeit zu einer interaktiven Allergieaufklärung, während der Beat Allergy Walk & Run Spenden für die Glasgow Children’s Hospital Charity sammelte und damit die Verpflichtung der EAACI für soziale Verantwortung und gesellschaftliches Engagement bekräftigte.

„Der Geist der Zusammenarbeit, den wir in Glasgow erlebt haben, war außergewöhnlich“, so Prof. André Moreira, EAACI Vice President Congresses. „Diese Energie wird nun in konkrete Initiativen und globale Partnerschaften umgesetzt.“

Der Kongress hob auch das Engagement der EAACI für Mentoring, digitale Gesundheitsinnovationen und die Stärkung der Patientenrechte hervor.

Der Countdown für den EAACI–Kongress 2026 in Istanbul hat offiziell begonnen, aber Sie müssen nicht bis dahin warten, um wieder in die Welt der Spitzenforschung einzutauchen. Von gezielten Meetings bis hin zu praxisorientierten Kursen – die EAACI bietet Ihnen ein umfangreiches Programm, das Sie das ganze Jahr über inspirieren wird. Informieren Sie sich über die nächsten Termine unter https://eaaci.org.

Über die EAACI
Die European Academy of Allergy and Clinical Immunology (EAACI) ist Europas größter Fachverband in diesem Bereich und hat sich der Förderung der Forschung und Versorgung von Menschen mit allergischen Erkrankungen verschrieben.

Erfahren Sie mehr: https://eaaci.org

Kontakt: [email protected] | +41 44 205 55 33

Ein Foto zu dieser Mitteilung ist verfügbar unter http://www.globenewswire.com/NewsRoom/AttachmentNg/60c21700–f7c9–486c–a72f–f699174a926a


GLOBENEWSWIRE (Distribution ID 1001118256)

EAACI Leadership Reflects on Record-Breaking Congress 2025: A Pivotal Moment for Allergy and Immunology

ZURICH, July 17, 2025 (GLOBE NEWSWIRE) — With over 7,600 delegates in attendance, EAACI Congress 2025 made headlines not just for its scale but for the powerful message delivered by its leadership. Now, one month after the Congress concluded in Glasgow, EAACI’s top figures are sharing their reflections on what they call a turning point for the field. Held from 13–16 June at the Scottish Event Campus, the event championed the theme: “Breaking Boundaries in Allergy, Asthma, and Clinical Immunology: Integrating Planetary Health for a Sustainable Future.”

“This year’s Congress was a turning point,” said Prof. Maria Torres, EAACI President. “We are entering an era where scientific innovation, equity in care, and environmental health must move forward together.”

The programme featured over 250 hours of lectures, workshops, and symposia, covering groundbreaking advances in drug allergy, T2 inflammation, paediatric asthma, and hereditary angioedema. The Presidential Symposium tackled antimicrobial resistance through a One Health lens, while a timely session on climate change and insect allergy drew global attention to ecological impacts on patient care.

Far beyond the walls of the SEC, the EAACI Congress 2025 activated the entire city with initiatives that brought science to the streets. The Clinical Village at the Glasgow Science Centre welcomed the public for hands–on allergy education, while the Beat Allergy Walk & Run raised funds for the Glasgow Children’s Hospital Charity, reinforcing EAACI’s commitment to social impact and community engagement.

“The spirit of collaboration we witnessed in Glasgow was extraordinary,” said Prof. André Moreira, EAACI Vice President Congresses. “This energy is now translating into real–world initiatives and global partnerships.”

The Congress also highlighted EAACI’s dedication to mentorship, digital health innovation, and amplifying patient’s voices.

The countdown for the EAACI Congress 2026 in Istanbul has officially begun, but you won’t have to wait until then to dive back into cutting–edge science. From focused meetings to hands–on courses, EAACI has a packed calendar to keep you inspired all year long. Check out what’s coming next at https://eaaci.org.

About EAACI
The European Academy of Allergy and Clinical Immunology (EAACI) is Europe’s largest professional association in the field, committed to advancing research and care for those affected by allergic diseases.

Learn more: https://eaaci.org

Contact: [email protected] | +41 44 205 55 33

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/60c21700–f7c9–486c–a72f–f699174a926a


GLOBENEWSWIRE (Distribution ID 1001118256)

La direction de l’EAACI fait le point sur son remarquable congrès 2025 représentant un tournant décisif pour l’allergologie et l’immunologie

ZURICH, 17 juill. 2025 (GLOBE NEWSWIRE) — Le congrès 2025 de l’EAACI a fait couler beaucoup d’encre à l’appui de ses 7 600 participants et plus, de son envergure et du message fort porté par son comité directeur. Un mois après la clôture de l’événement qui s’est tenu à Glasgow, les figures de proue de l’EAACI reviennent collectivement sur ce qu’ils qualifient de tournant décisif. Organisé du 13 au 16 juin au Scottish Event Campus, le congrès était placé sous le thème suivant : « Repousser les limites dans les domaines de l’allergie, de l’asthme et de l’immunologie clinique et intégrer la santé planétaire pour un avenir durable ».

Pour la professeure Maria Torres, présidente de l’EAACI, « Le congrès de cette année marque un véritable tournant. Nous entrons dans une phase où l’innovation scientifique, l’équité de traitement et la santé environnementale doivent avancer ensemble ».

Le programme s’est décliné en plus de 250 heures de conférences, d’ateliers et de symposiums et a permis de présenter des avancées majeures dans des domaines thérapeutiques comme l’allergie médicamenteuse, l’inflammation de type 2, l’asthme pédiatrique ou encore l’angioœdème héréditaire. Le symposium présidentiel a exposé la résistance aux antimicrobiens sous l’angle de l’approche « One Health » (une santé commune à tous) tandis qu’une session très attendue portant sur le changement climatique et les allergies aux insectes a attiré l’attention du monde entier sur les impacts écologiques des soins aux patients.

Bien au–delà des murs du Scottish Event Campus, le congrès EAACI 2025 a fait vivre tout Glasgow au rythme de projets entendant rapprocher la science du grand public. Installé au musée scientifique de la ville, le « Clinical Village » (village clinique) a proposé un enseignement pratique ciblé sur les allergies aux visiteurs, tandis que la course « Beat Allergy Walk & Run » visait à collecter des fonds destinés à l’association caritative Glasgow Children’s Hospital Charity. Ces deux événements viennent renforcer l’engagement de l’EAACI en faveur de l’impact social et de l’engagement collectif.

« Nous avons pu observer un formidable esprit de collaboration à Glasgow » indique le professeur André Moreira, vice–président du Congrès de l’EAACI. « Toute cette belle énergie se traduit désormais par des initiatives concrètes et des partenariats conclus à l’échelle mondiale ».

Le congrès a également permis de souligner l’engagement de l’EAACI en faveur du mentorat, de l’innovation en santé numérique, et de l’écho donné à la voix des patients.

Le compte à rebours du congrès EAACI 2026 organisé à Istanbul est désormais lancé, mais vous n’avez nul besoin d’attendre cet événement pour vous replonger dans la science de pointe. En effet, l’EAACI propose un calendrier nourri de réunions ciblées et de formations pratiques pour abreuver vos connaissances tout au long de l’année. Nous vous invitions à prendre connaissance des prochains événements depuis la page : https://eaaci.org.

À propos de l’EAACI
L’Académie européenne d’allergologie et d’immunologie clinique (EAACI) est la plus grande association professionnelle européenne de ces domaines thérapeutiques. Elle s’engage à faire progresser la recherche et les soins pour les personnes atteintes de maladies allergiques.

Pour en savoir plus, rendez–vous sur https://eaaci.org

Cordonnées : [email protected] | +41 44 205 55 33

Une photo annexée au présent communiqué est disponible à l’adresse suivante : http://www.globenewswire.com/NewsRoom/AttachmentNg/60c21700–f7c9–486c–a72f–f699174a926a


GLOBENEWSWIRE (Distribution ID 1001118256)

Liderança da EAACI reflete sobre o Congresso Recorde de 2025: um momento crucial para as áreas de Alergia e Imunologia

ZURIQUE, July 17, 2025 (GLOBE NEWSWIRE) — Com mais de 7.600 delegados presentes, o Congresso da EAACI 2025 foi manchete não apenas por sua magnitude, mas pela mensagem poderosa transmitida por sua liderança. Agora, um mês após a conclusão do Congresso em Glasgow, as principais figuras da EAACI estão compartilhando suas reflexões sobre o que eles chamam de um divisor de águas para o campo. Realizado de 13 a 16 de junho no Scottish Event Campus, o evento defendeu o tema: “Rompendo fronteiras nas áreas de alergia, asma e imunologia clínica: integração da saúde planetária para um futuro sustentável”.

“O Congresso deste ano foi um divisor de águas”, declarou a Profa. Maria Torres, Presidente da EAACI. “Estamos entrando em uma era na qual a inovação científica, a equidade no atendimento e a saúde ambiental devem avançar de maneira conjunta.”

O programa contou com mais de 250 horas de palestras, workshops e simpósios, abordando avanços inovadores em alergia a medicamentos, inflamação tipo 2 (T2), asma pediátrica e angioedema hereditário. O Simpósio Presidencial abordou a resistência antimicrobiana pela perspectiva da Saúde Única, enquanto uma sessão oportuna sobre as mudanças climáticas e a alergia a insetos chamou a atenção global para os impactos ecológicos no atendimento aos pacientes.

Muito além dos muros da SEC, o Congresso da EAACI 2025 movimentou toda a cidade com iniciativas que levaram a ciência às ruas. A Vila Clínica, localizada no Centro de Ciências de Glasgow, recebeu o público para uma atividade educacional prática sobre alergias, enquanto a caminhada e corrida Beat Allergy Walk & Run arrecadou fundos para a Organização Beneficente do Hospital Infantil de Glasgow, reforçando o compromisso da EAACI com o impacto social e o engajamento comunitário.

“O espírito de colaboração que testemunhamos em Glasgow foi extraordinário”, declarou o Prof. André Moreira, Vice–Presidente de Congressos da EAACI. “Essa energia agora se traduz em iniciativas reais e parcerias globais.”

O Congresso também destacou a dedicação da EAACI à mentoria, à inovação em saúde digital e à amplificação das vozes dos pacientes.

A contagem regressiva para o Congresso da EAACI 2026 em Istambul começou oficialmente, mas você não precisará esperar até lá para mergulhar outra vez na ciência de ponta. De reuniões para tratar temas específicos a cursos práticos, a EAACI tem uma agenda repleta de opções para mantê–lo inspirado o ano todo. Confira o que vem por aí em https://eaaci.org.

Sobre a EAACI
A Academia Europeia de Alergia e Imunologia Clínica (EAACI) é a maior associação profissional da Europa na área, comprometida em promover a pesquisa e o tratamento de pessoas afetadas por doenças alérgicas.

Saiba mais em https://eaaci.org

Contato: [email protected] | +41 44 205 55 33

Uma foto que acompanha este anúncio está disponível em http://www.globenewswire.com/NewsRoom/AttachmentNg/60c21700–f7c9–486c–a72f–f699174a926a


GLOBENEWSWIRE (Distribution ID 1001118256)

Fortrea & Emery Pharma Anunciam Colaboração Estratégica para Fornecer Estudos de Interação Medicamentosa Usando Rifampicina em Conformidade com o FDA

DURHAM, N.C., June 24, 2025 (GLOBE NEWSWIRE) — A Fortrea (Nasdaq: FTRE) (a “Empresa”), uma organização líder global de pesquisa por contrato (CRO), anunciou hoje uma colaboração estratégica com a Emery Pharma, uma CRO analítica e bioanalítica líder que fornece serviços de teste sob as atuais Boas Práticas de Fabricação (cGMP) e Boas Práticas de Laboratório (GLP), para teste rápido lote a lote, 1–metil–4–nitrosopiperazina (MNP) de rifampicina, o medicamento preferido para estudos de interação medicamentosa (DDI), para certificar que as impurezas estão abaixo do Limite de Ingestão Aceitável (AI) estabelecido pelas diretrizes do Food and Drug Administration (FDA) dos EUA.

A Fortrea selecionou a Emery Pharma devido à sua profunda capacidade de testes analíticos e bioanalíticos, em apoio aos programas clínicos globais da Fortrea. A experiência da Emery Pharma nesta área complementa a capacidade da Fortrea de oferecer rifampicina como agente para induzir a isoenzima CYP3A4 em estudos de DDI. A colaboração anunciada hoje viabiliza que os patrocinadores realizem avaliações de DDI usando rifampicina, o agente preferido nesses estudos devido ao seu perfil de segurança e tolerabilidade.

“Essa colaboração é um exemplo do nosso compromisso compartilhado em um projeto de estudo mais inteligente e maior segurança dos participantes”, disse Oren Cohen, M.D., diretor médico e presidente dos Serviços de Farmacologia Clínica da Fortrea. “Ao viabilizar o uso da rifampicina por meio da nossa colaboração com a Emery Pharma, ajudamos os patrocinadores a reduzir o risco dos testes em fase inicial, acelerar cronogramas e aumentar a qualidade dos dados. A profunda experiência da Emery Pharma em ciências bioanalíticas, juntamente com suas capacidades de GLP e GMP, combinadas com a capacidade de conduta clínica líder da indústria da Fortrea, tornam esta colaboração ideal para o teste de rifampicina para uso em nossos estudos de DDI. A colaboração aprofunda nossa capacidade de gerar dados de alta qualidade que beneficiarão pacientes em todo o mundo.”

Ron Najafi, Ph.D., diretor executivo da Emery Pharma, acrescentou: “Estamos honrados com a parceria com a Fortrea no avanço de estudos críticos em fase inicial. A força da nossa equipe está em resolver desafios analíticos complexos e garantir que os estudos atendam aos mais altos padrões regulatórios e científicos. Estamos empolgados em contribuir para um desenvolvimento de medicamentos mais seguro, rápido e eficaz.”

Os estudos de DDI são essenciais para o desenvolvimento de novas terapêuticas. A rifampicina, um antibiótico amplamente utilizado e tradicionalmente uma ferramenta essencial para os estudos de DDI, tem enfrentado escrutínio devido à descoberta de MNP, uma impureza de nitrosamina. Em 2021, o FDA descobriu que todos os lotes de rifampicina testados continham níveis de MNP que excediam os limites aceitos anteriormente, levando os pesquisadores a explorar medicamentos alternativos. No entanto, esses substitutos trazem preocupações de segurança e tempos de ativação mais lentos. Em 2023, o FDA atualizou sua orientação, elevando o limite aceitável de MNP na rifampicina.

Esta abordagem inovadora aos testes de níveis de impurezas da rifampicina agora está disponível para os clientes da Fortrea que realizam ensaios de farmacologia clínica, com projetos de estudo flexíveis que atendem aos requisitos do FDA.

Sobre a Fortrea

A Fortrea (Nasdaq: FTRE) é fornecedora líder global de soluções para o desenvolvimento clínico 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 e serviços de consultoria. 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 cerca de 100 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 pacientes em Fortrea.com e siga–nos em LinkedIn e X (ex–Twitter).

Sobre a Emery Pharma

A Emery Pharma é uma organização líder em pesquisa de contratos analíticos e bioanalíticos com sede em Alameda, Califórnia, reconhecida por sua liderança científica em análise de impurezas e conformidade regulatória. Especializada em testes analíticos compatíveis com GLP e cGMP, a empresa fornece um conjunto abrangente de serviços que apoiam todas as etapas do desenvolvimento de medicamentos – desde a descoberta precoce até ensaios clínicos e comercialização.

Pioneira no desenvolvimento e validação de ensaios sensíveis e específicos para detecção de nitrosaminas, a Emery Pharma tem tido um papel fundamental em ajudar patrocinadores e fabricantes farmacêuticos a navegar pelas diretrizes em evolução do FDA e da ICH. A capacidade de ponta da empresa em cromatografia líquida–espectrometria de massa (LC–MS/MS) e espectrometria de massa de alta resolução (HRMS) permitem a quantificação precisa de impurezas da nitrosamina a nível de traço, incluindo NDSRIs, NDMA e MNP, em matrizes complexas.

A Emery Pharma também oferece triagem de antibióticos, programas robustos de teste de estabilidade de produtos em estágio de pesquisa e comerciais, juntamente com plataformas analíticas avançadas, como ressonância magnética nuclear (NMR) e cromatografia gasosa–espectrometria de massa (GC–MS). Sua equipe de cientistas interdisciplinares oferece serviços de solução de problemas, desenvolvimento de métodos e investigação com um forte foco no preparo regulatório e na integridade dos dados.

Impulsionada pelo compromisso com a excelência científica e a saúde pública, a Emery Pharma continua a avançar no campo da definição de perfis de impurezas – garantindo medicamentos mais seguros e contribuindo para os esforços de toda a indústria para mitigar os riscos associados às nitrosaminas e outros contaminantes genotóxicos.

Para mais informações, visite emerypharma.com e siga–nos no LinkedIn.

Contatos da Fortrea:

Galen Wilson (Mídia) – 703–298–0802, [email protected]
Kate Dillon (Mídia) – 646–818–9115, [email protected]
Hima Inguva (Investidores) – 877–495–0816, [email protected]

Contato da Emery Pharma:

Chris Purcell (Desenvolvimento de Negócios) – 510–929–9262, [email protected]


GLOBENEWSWIRE (Distribution ID 9483635)

Fortrea et Emery Pharma annoncent une collaboration stratégique visant à mener des études sur les interactions médicamenteuses répondant aux normes de la FDA en utilisant la rifampicine

DURHAM, Caroline du Nord, 24 juin 2025 (GLOBE NEWSWIRE) — Fortrea (Nasdaq : FTRE) (la « Société »), une société de recherche contractuelle d’envergure mondiale (CRO) de premier plan, a annoncé aujourd’hui une collaboration stratégique avec Emery Pharma, une CRO analytique et bioanalytique de pointe, fournissant des services d’analyse conformes aux Bonnes Pratiques de Fabrication actuelles (BPF) et aux Bonnes Pratiques de Laboratoire (BPL). Cette collaboration vise à proposer un test rapide, lot par lot, de la 1–méthyl–4–nitrosopipérazine (MNP) de la rifampicine, le médicament de référence pour les études d’interactions médicamenteuses (IM), afin de certifier que les impuretés sont inférieures à la limite d’ingestion acceptable (IA) définie par les directives de la Food and Drug Administration (FDA) des États–Unis.

Fortrea a choisi Emery Pharma en raison de ses solides compétences en matière de tests analytiques et bioanalytiques, soutenant ainsi les programmes cliniques mondiaux de Fortrea. L’expertise d’Emery Pharma dans ce domaine permet à Fortrea de proposer la rifampicine comme agent inducteur de l’isoenzyme CYP3A4 dans les études d’IM. La collaboration annoncée aujourd’hui permet aux commanditaires de réaliser des évaluations d’IM en utilisant la rifampicine, fréquemment citée comme l’agent de référence dans ces études en raison de son profil d’innocuité et de tolérance.

« Cette collaboration reflète notre engagement commun en faveur d’une conception plus intelligente des études et d’une sécurité renforcée pour les participants » a indiqué Oren Cohen, M.D., Directeur médical et Président des services de pharmacologie clinique chez Fortrea. Et d’ajouter en ces termes « En permettant l’utilisation de la rifampicine grâce à notre collaboration avec Emery Pharma, nous aidons les promoteurs à réduire les risques des essais en phase précoce, à accélérer les délais et à améliorer la qualité des essais. L’expertise approfondie d’Emery Pharma dans les sciences bioanalytiques, associée à ses capacités de conformité au regard des BPL et des BPF, constitue un atout majeur. Combinée aux compétences de Fortrea pour conduire des études cliniques d’envergure internationale, cette collaboration représente une alliance idéale. Elle permettra de tester la rifampicine dans le cadre de nos études d’interactions médicamenteuse. Ainsi cette collaboration renforce notre capacité à produire des données de haute qualité qui bénéficieront aux patients du monde entier ».

De son côté, Ron Najafi, Ph.D., directeur général d’Emery Pharma, a ajouté « C’est un honneur pour nous de collaborer avec Fortrea pour faire progresser les études critiques en phase précoce. La force de notre équipe réside dans sa capacité à résoudre des défis analytiques complexes et à garantir que les études respectent les normes réglementaires et scientifiques les plus strictes. Nous sommes enthousiastes à l’idée de contribuer au développement de médicaments plus sûrs, plus rapides et plus efficaces ».

Les études d’IM constituent la pierre angulaire dans le développement de nouveaux traitements. La rifampicine, un antibiotique largement utilisé et traditionnellement inclus comme un outil clé dans les études d’IM, a fait l’objet d’une attention particulière en raison de la découverte de la MNP, une impureté de nitrosamine. En 2021, la FDA a constaté que tous les lots de rifampicine présentaient des niveaux de MNP qui dépassaient les limites précédemment acceptées, ce qui a incité les chercheurs à explorer des médicaments alternatifs. Toutefois, ces substituts posent des problèmes de sécurité et présentent des temps d’activation plus lents. En 2023, la FDA a mis à jour ses directives, augmentant la limite acceptable de MNP pour la rifampicine.

Cette approche innovante de tests des niveaux d’impureté de la rifampicine est désormais disponible pour les clients de Fortrea qui mènent des essais de pharmacologie clinique, avec des protocoles d’études flexibles répondant aux exigences de la FDA.

À propos de Fortrea

Fortrea (Nasdaq : FTRE) est un fournisseur mondial de premier plan de solutions de développement clinique pour le secteur des sciences de la vie. Fortrea s’associe à des sociétés établies et émergentes du domaine biopharmaceutique, de la biotechnologie, des dispositifs médicaux et des diagnostics pour stimuler l’innovation en matière de santé, et accélérer la mise au point de traitements révolutionnaires pour les patients. Fortrea propose des services de gestion d’essais cliniques de phase I à IV, de pharmacologie clinique et de consulting. 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, qui travaille dans près de 100 pays, est dimensionnée pour fournir des solutions ciblées et flexibles à nos clients, partout dans le monde. Pour en savoir plus sur la manière dont Fortrea est un moteur d’influence du pipeline au patient, rendez–vous sur Fortrea.com et suivez–nous sur LinkedIn et X (anciennement Twitter).

À propos d’Emery Pharma

Emery Pharma est une société de recherche contractuelle de premier plan spécialisée en analyses analytiques et bioanalytiques basée à Alameda en Californie, reconnue pour son expertise scientifique en matière d’analyse des impuretés et de conformité réglementaire. Spécialisée dans les tests analytiques conformes aux normes BPL et BPF, l’entreprise propose une gamme complète de services qui soutiennent chaque étape du développement des médicaments, de la découverte initiale aux essais cliniques, jusqu’à la commercialisation.

Société pionnière dans le développement et la validation de tests sensibles et spécifiques pour la détection des nitrosamines, Emery Pharma a joué un rôle clé en aidant les promoteurs et les fabricants de produits pharmaceutiques à s’adapter à l’évolution des directives de la FDA et de l’ICH. Les capacités de pointe de l’entreprise en matière de chromatographie liquide couplée à la spectrométrie de masse (LC–MS/MS) et de spectrométrie de masse à haute résolution (HRMS) permettent la quantification précises des impuretés nitrosamines à l’état de traces, y compris les NDSRI, NDMA et MNP, dans des matrices complexes.

Emery Pharma propose également un criblage des antibiotiques, des programmes robustes de tests de stabilité pour les produits en phase de recherche et les produits commercialisés, ainsi que des plateformes analytiques avancées telles que la résonance magnétique nucléaire (RMN) et la chromatographie gazeuse couplée à la spectrométrie de masse (GC–MS). Son équipe de scientifiques interdisciplinaires fournit des services de résolution de problèmes, de développement de méthodes et d’investigation, avec un fort accent porté sur la conformité réglementaire et l’intégrité des données.

Animée par un engagement en faveur de l’excellence scientifique et de la santé publique, Emery Pharma continue de faire progresser le domaine du profilage des impuretés, garantissant des médicaments plus sûrs et contribuant aux efforts déployés à l’échelle du secteur pour réduire les risques liés aux nitrosamines et autres contaminants génotoxiques.

Pour en savoir plus, consultez le site www.emerypharma.com et suivez–nous sur LinkedIn.

Contacts Fortrea :

Galen Wilson (Médias) – 703–298–0802, [email protected]
Kate Dillon (Médias) – 646–818–9115, [email protected]
Hima Inguva (Investisseurs) – 877–495–0816, [email protected]

Contacts pour Emery Pharma :

Chris Purcell (Développement commercial) – 510–929–9262, [email protected]


GLOBENEWSWIRE (Distribution ID 9483635)

Fortrea und Emery Pharma kündigen strategische Zusammenarbeit zur Durchführung FDA-konformer Arzneimittelwechselwirkungsstudien mit Rifampin an

Durham, North Carolina, June 24, 2025 (GLOBE NEWSWIRE) — Fortrea (Nasdaq: FTRE) (das „Unternehmen“), ein führendes globales Auftragsforschungsinstitut (Contract Research Organization CRO), hat heute eine strategische Zusammenarbeit mit Emery Pharma bekanntgegeben. Emery Pharma ist ein führendes analytisches und bioanalytisches CRO, das Prüfdienstleistungen unter der aktuellen Guten Herstellungspraxis (cGMP) und der Guten Laborpraxis (GLP) anbietet. Ziel ist es, eine schnelle Los–für–Los–Prüfung von 1–Methyl–4–Nitrosopiperazin (MNP) von Rifampin, dem bevorzugten Medikament für Arzneimittelwechselwirkungsstudien (Drug–Drug Interaction, DDI), bereitzustellen. Damit soll bescheinigt werden, dass die Verunreinigungen unter dem von der U.S. Food and Drug Administration (FDA) festgelegten Acceptable Intake (AI)–Limit liegen.

Fortrea hat sich für Emery Pharma entschieden, da das Unternehmen über starke Kompetenzen im Bereich analytischer und bioanalytischer Tests zur Unterstützung der globalen klinischen Programme von Fortrea verfügt. Das Fachwissen von Emery Pharma in diesem Bereich erweitert die Möglichkeiten von Fortrea, Rifampin als Mittel zur Induktion des CYP3A4–Isoenzyms in DDI–Studien einzusetzen. Die heute bekanntgegebene Zusammenarbeit ermöglicht es Sponsoren, DDI–Bewertungen mit Rifampin durchzuführen. Aufgrund seines Sicherheits– und Verträglichkeitsprofils wird Rifampin in diesen Studien häufig als bevorzugter Wirkstoff genannt.

„Diese Zusammenarbeit spiegelt unser gemeinsames Engagement für ein intelligenteres Studiendesign und mehr Sicherheit für die Teilnehmer wider“, so Dr. Oren Cohen, Chief Medical Officer und President of Clinical Pharmacology Services bei Fortrea. „Durch die Kooperation mit Emery Pharma ermöglichen wir die Verwendung von Rifampin. Damit unterstützen wir Sponsoren dabei, das Risiko von Studien in der frühen Phase zu minimieren, die Durchführung zu beschleunigen und die Datenqualität zu optimieren. Die fundierten Fachkenntnisse von Emery Pharma in den bioanalytischen Wissenschaften, gepaart mit Guter Laborpraxis (GLP) und Guter Herstellungspraxis (GMP), in Verbindung mit den branchenführenden Fähigkeiten von Fortrea im Bereich der klinischen Durchführung, machen diese Zusammenarbeit zur idealen Lösung für die Prüfung von Rifampin in unseren DDI–Studien. Durch die Zusammenarbeit sind wir in der Lage, qualitativ hochwertige Daten zu generieren, von denen Patienten weltweit profitieren werden.“

Dr. Ron Najafi, CEO von Emery Pharma, fügte hinzu: „Wir freuen uns darauf, mit Fortrea zusammenzuarbeiten, um wichtige Frühphasenstudien voranzutreiben. Die Stärke unseres Teams liegt in der Lösung komplexer analytischer Herausforderungen sowie in der Gewährleistung, dass die Studien den höchsten gesetzlichen und wissenschaftlichen Standards entsprechen. Wir freuen uns darauf, einen Beitrag zu einer sichereren, schnelleren und wirksameren Entwicklung von Arzneimitteln zu leisten.“

DDI–Studien sind ein wichtiger Eckpfeiler bei der Entwicklung neuer Therapeutika. Rifampin ist ein weit verbreitetes Antibiotikum und war traditionell ein Schlüsselinstrument in DDI–Studien. Aufgrund der Entdeckung von MNP (eine Nitrosamin–Verunreinigung) wurde es jedoch kritisch beäugt. Im Jahr 2021 stellte die FDA fest, dass alle getesteten Rifampin–Chargen MNP–Gehalte aufwiesen, die über den bisher akzeptierten Grenzwerten lagen. Dies veranlasste die Forscher, nach alternativen Medikamenten zu suchen. Mit diesen Ersatzstoffen sind jedoch Sicherheitsbedenken und langsamere Aktivierungszeiten verbunden. Im Jahr 2023 hat die FDA ihre Leitlinien aktualisiert und den zulässigen MNP–Grenzwert für Rifampin erhöht.

Kunden von Fortrea, die klinische Pharmakologiestudien mit flexiblen Studiendesigns durchführen, die den Anforderungen der FDA entsprechen, können nun diesen innovativen Ansatz zur Prüfung des Rifampin–Verunreinigungsgrads nutzen.

Über Fortrea

Fortrea (Nasdaq: FTRE) ist ein weltweit führender Anbieter von Lösungen für die klinische Entwicklung in der Life–Sciences–Branche. Um Innovationen im Gesundheitswesen voranzutreiben und das Angebot lebensverändernder Therapien für Patienten zu beschleunigen, arbeiten wir mit aufstrebenden und großen biopharmazeutischen, biotechnologischen, medizintechnischen und diagnostischen Unternehmen zusammen. Fortrea bietet das Management von klinischen Studien der Phasen I–IV, klinische Pharmakologie sowie Beratungsdienste an. Die Lösungen von Fortrea basieren auf drei Jahrzehnten Erfahrung in mehr als 20 Therapiegebieten, einer Leidenschaft für wissenschaftliche Strenge, außergewöhnlichen Erkenntnissen und einem starken Netzwerk von Prüfzentren. Unser talentiertes und vielfältiges Team, das in etwa 100 Ländern tätig ist, ist darauf ausgelegt, Kunden weltweit fokussierte und flexible Lösungen zu bieten. Erfahren Sie mehr darüber, wie Fortrea zu einer transformativen Kraft von der Pipeline bis zum Patienten wird. Besuchen Sie dazu unsere Website unter Fortrea.com und folgen Sie uns auf LinkedIn und X (ehemals Twitter).

Über Emery Pharma

Emery Pharma ist ein führendes Auftragsforschungsunternehmen für analytische und bioanalytische Dienstleistungen mit Sitz in Alameda, Kalifornien. Das Unternehmen ist bekannt für seine wissenschaftliche Führungsrolle bei der Analyse von Verunreinigungen und der Einhaltung von Vorschriften. Das Unternehmen ist auf analytische Tests spezialisiert, die den Richtlinien der Guten Laborpraxis (GLP) und der aktuellen Guten Herstellungspraxis (cGMP) entsprechen, und bietet eine umfassende Palette von Dienstleistungen an, die jede Phase der Arzneimittelentwicklung unterstützen – von der frühen Entdeckung bis hin zu klinischen Studien und der Vermarktung.

Als Pionier in der Entwicklung und Validierung empfindlicher und spezifischer Tests zum Nachweis von Nitrosaminen spielte Emery Pharma eine Schlüsselrolle bei der Unterstützung von Pharmaunternehmen im Umgang mit den sich entwickelnden FDA– und ICH–Richtlinien. Dank der hochmodernen Fähigkeiten des Unternehmens in den Bereichen Flüssigchromatographie–Massenspektrometrie (LC–MS/MS) und hochauflösende Massenspektrometrie (HRMS) ist eine präzise Quantifizierung von Nitrosamin–Verunreinigungen im Spurenbereich möglich. Dazu zählen NDSRIs, NDMA und MNP in komplexen Matrizen.

Emery Pharma bietet außerdem ein Antibiotika–Screening, robuste Stabilitätsprüfungsprogramme für Produkte in der Forschungsphase und für kommerzielle Produkte sowie fortschrittliche Analyseplattformen wie Kernspinresonanz (NMR) und Gaschromatographie–Massenspektrometrie (GC–MS). Das Team aus interdisziplinären Wissenschaftlern bietet Problemlösungen, Methodenentwicklung und Prüfdienstleistungen, wobei der Fokus stark auf regulatorischer Bereitschaft und Datenintegrität liegt.

Angespornt durch sein Engagement für wissenschaftliche Spitzenleistungen und die öffentliche Gesundheit treibt Emery Pharma die Erstellung von Verunreinigungsprofilen weiter voran. Dadurch werden Arzneimittel sicherer und die Branche kann die mit Nitrosaminen und anderen genotoxischen Verunreinigungen verbundenen Risiken besser mindern.

Für weitere Informationen besuchen Sie uns aufemerypharma.comund folgen Sie uns auf LinkedIn.

Kontakt zu Fortrea:

Galen Wilson (Medien) – 703–298–0802, [email protected]
Kate Dillon (Medien) – 646–818–9115, [email protected]
Hima Inguva (Anleger) – 877–495–0816, [email protected]

Kontakt zu Emery Pharma

Chris Purcell (Business Development) – 510–929–9262, [email protected]


GLOBENEWSWIRE (Distribution ID 9483635)

Fortrea & Emery Pharma Announce Strategic Collaboration to Deliver FDA Compliant Drug-Drug-Interaction Studies Using Rifampin

DURHAM, N.C., June 24, 2025 (GLOBE NEWSWIRE) — Fortrea (Nasdaq: FTRE) (the “Company”), a leading global contract research organization (CRO), today announced a strategic collaboration with Emery Pharma, a leading analytical and bioanalytical CRO providing testing services under current Good Manufacturing Practice (cGMP) and Good Laboratory Practice (GLP), to provide rapid lot–by–lot, 1–methyl–4–nitrosopiperazine (MNP) testing of rifampin, the preferred drug for drug–drug interaction (DDI) studies, to certify impurities are below the Acceptable Intake (AI) Limit set by U.S. Food and Drug Administration (FDA) guidelines.

Fortrea has selected Emery Pharma due to its strong capabilities in analytical and bioanalytical testing in support of Fortrea’s global clinical programs. Emery Pharma’s expertise in this area supports Fortrea’s ability to offer rifampin as an agent for inducing the CYP3A4 isoenzyme in DDI studies. The collaboration announced today allows sponsors to conduct DDI assessments using rifampin, which is frequently named as the preferred agent in these studies, due to its safety and tolerability profile.

“This collaboration reflects our shared commitment to smarter study design and greater participant safety,” said Oren Cohen, M.D., chief medical officer and president of Clinical Pharmacology Services at Fortrea. “By enabling use of rifampin through our collaboration with Emery Pharma, we’re helping sponsors de–risk early–phase trials, accelerate timelines and enhance data quality. Emery Pharma’s deep expertise in bioanalytical sciences, coupled with their GLP and GMP capabilities, combined with Fortrea’s industry–leading clinical conduct capabilities makes this an ideal collaboration for the testing of rifampin for use in our DDI studies. The collaboration strengthens our ability to generate high–quality data that will benefit patients worldwide.”

Ron Najafi, Ph.D., chief executive officer of Emery Pharma, added, “We’re honored to partner with Fortrea in advancing critical early–phase studies. Our team’s strength lies in solving complex analytical challenges and ensuring studies meet the highest regulatory and scientific standards. We’re excited to contribute to safer, faster and more effective drug development.”

DDI studies are a cornerstone in the development of new therapeutics. Rifampin, a widely used antibiotic and traditionally a key tool in DDI studies, has faced scrutiny due to the discovery of MNP, a nitrosamine impurity. In 2021, the FDA found that all tested rifampin batches contained MNP levels exceeding previously accepted limits, prompting researchers to explore alternative drugs. However, these substitutes come with safety concerns and slower activation times. In 2023, the FDA updated its guidance, raising the acceptable MNP limit for rifampin.

This innovative approach of testing rifampin impurity levels is now available to Fortrea customers conducting clinical pharmacology trials, with flexible study designs that meet FDA requirements.

About Fortrea

Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, biotechnology, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients. Fortrea provides phase I–IV clinical trial management, clinical pharmacology and consulting services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team working in about 100 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com and follow us on LinkedIn and X (formerly Twitter).

About Emery Pharma

Emery Pharma is a leading analytical and bioanalytical contract research organization based in Alameda, California, recognized for its scientific leadership in impurity analysis and regulatory compliance. Specializing in GLP– and cGMP–compliant analytical testing, the company provides a comprehensive suite of services that support every stage of drug development—from early discovery through clinical trials and commercialization.

A pioneer in the development and validation of sensitive and specific assays for nitrosamine detection, Emery Pharma has played a key role in helping pharmaceutical sponsors and manufacturers navigate evolving FDA and ICH guidelines. The company’s cutting–edge capabilities in liquid chromatography–mass spectrometry (LC–MS/MS) and high–resolution mass spectrometry (HRMS) enable the precise quantification of trace–level nitrosamine impurities, including NDSRIs, NDMA and MNP, in complex matrices.

Emery Pharma also offers antibiotic screening, robust stability testing programs for both research–stage and commercial products, along with advanced analytical platforms such as nuclear magnetic resonance (NMR) and gas chromatography–mass spectrometry (GC–MS). Its team of interdisciplinary scientists delivers problem–solving, method development and investigational services with a strong focus on regulatory readiness and data integrity.

Driven by a commitment to scientific excellence and public health, Emery Pharma continues to advance the field of impurity profiling—ensuring safer medicines and contributing to industry–wide efforts to mitigate the risks associated with nitrosamines and other genotoxic contaminants.

For more information, visit us at emerypharma.com and follow us on LinkedIn.

Fortrea Contacts:

Galen Wilson (Media) – 703–298–0802, [email protected]
Kate Dillon (Media) – 646–818–9115, [email protected]
Hima Inguva (Investors) – 877–495–0816, [email protected]

Emery Pharma Contacts:

Chris Purcell (Business Development) – 510–929–9262, [email protected]


GLOBENEWSWIRE (Distribution ID 9482882)