Clinigen's approval of PreemieFort® Enteral Solution in Japan marks a significant milestone in neonatal care. This first of its kind human milk-based product enhances nutrition for vulnerable infants.

LONDON--(Business Wire/Korea Newswire)--Clinigen, the global pharmaceutical services company dedicated to accelerating access to critical medicines worldwide, today announced the appointment of Greg Skalicky as Group Chief Executive Officer, effec...

Jerome Charton, chief executive of Clinigen, explains how to accelerate action for equitable access to essential medicines beyond international women’s day.

Clinigen obtained approval for Prolacta’s “PreemieFort® Enteral Solution”, a human milk-based fortifier, as an approved pharmaceutical product in Japan indicated for the “Nutritional management of neonates and infants presenting with weight gain failure such as very low birth weight (VLBW) infants.” The approval was supported by data from the pivotal Japan-based JASMINE Phase III clinical […]

MaaT Pharma Announces 2025 Annual Results and Provides Business Updates Potential Pivotal Year for MaaT013 (Xervyteg®): Marketing Authorization Application (MAA) in Europe for MaaT013 (Xervyteg®) submitted to the European Medicines Agency (EMA) in June 2025 EMA feedback expected mid-2026 per current EMA timelines Commercial readiness continues, with the Clinigen agreement in place and the Early Access Program (EAP) successfully transferred Active discussions ongoing with the Food and Drug Administration (FDA) to assess potential clinical activities with the European regulatory pathway advancing as the primary focus for now EAP Revenues in 2025 of €4.4 million in 2025, a 38% increase over 2024, and the highest revenues generated from the EAP to date Pipeline progress continues: MaaT033, currently in Phase 2b potentially pivotal trial (PHOEBUS), is ongoing and continued to demonstrate a favorable safety profile, with six DSMB reviews completed in 2025. Topline results for PHOEBUS study are now expected in Q4 2028 (instead of Q4 2027) MaaT034 promising preclinical data presented at major scientific conferences €37.5 million financing agreement signed with the European Investment Bank (EIB), structured in four tranches; Tranches A (€3.5 million) drawn in October 2025, and Tranche B (€6 million) in process As of December 31, 2025, cash and cash equivalents were €24.9 million Cash runway to August 2026, including the upcoming EIB Tranche B funding of €6.0 million   Lyon, France, March 31, 2026 – 7:30 a.m. CET – MaaT Pharma(EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation,today reports the 2025 full-year annual results and provides business updates. “2025 was a year of strong clinical momentum for MaaT Pharma, marked by major advances across our hemato‑oncology portfolio and progress in immuno‑oncology. In 2026, we are approaching a potentially transformative milestone with the EMA review of MaaT013 (Xervyteg®), while continuing to expand our oncology platform. We believe MaaT Pharma is well‑positioned as a leader in microbiome‑driven therapies and we remain focused on advancing our pipeline with the ambition to bring new therapeutic options to patients with high unmet needs, “ stated Hervé Affagard, CEO and co-founder of MaaT Pharma. Pipeline highlights In Hemato-Oncology 2025 was an important year for MaaT Pharma, marked by continued progress for MaaT013 (Xervyteg®) and steps that reinforced the Company’s position in microbiome‑based therapies in hemato‑oncology. Looking ahead, 2026 is expected to be a pivotal year, as MaaT013 (Xervyteg®) advances through the EMA review process toward a potential first‑in‑class approval in oncology. The MAA submitted to the EMA is supported by results from the open‑label, single‑arm pivotal ARES trial, together with a dataset generated through the EAP. As a “first-in-class” potentially setting the foundations for future standards, MaaT013 (Xervyteg®) is being developed in the field of rare diseases and currently represents the Company’s most advanced drug candidate. Its development takes place in an environment characterized by specific pharmaceutical, clinical and regulatory questions, notably related to the innovative nature of its therapeutic approach. MaaT013 (Xervyteg®) is the most advanced step toward validating the Company’s oncology platform, which holds scalability potential, notably with MaaT033, an oral form, as the next expansion driver. Acute Graft-versus-Host Disease (aGvHD) – MaaT013 (Xervyteg®) In January 2025, the Company announced positive topline results from the pivotal ARES Study evaluating MaaT013 (Xervyteg®) in aGvHD, meeting its primary endpoint with a significant gastrointestinal overall response rate at Day 28 of 62% and demonstrating the unprecedented efficacy of MaaT013 (Xervyteg®) as third-line treatment of aGvHD with gastrointestinal involvement (GI-aGvHD) consistent with communicated E

MaaT Pharma to Present Four Abstracts at the52nd European Bone Marrow Transplantation Annual Meeting and to Highlight Clinigen-Hosted Industry Symposium on acute GvHD Management Oral presentation during Presidential Plenary Session to feature the final results of the ARES pivotal Phase 3 trial evaluating MaaT013 in acute Graft‑versus‑Host Disease (aGvHD) with gastrointestinal involvement Poster presentations for: CHRONOS, a multicenter retrospective cohort study describing real-world outcomes in third-line acute gastrointestinal GvHD not treated with microbiotherapy PHOEBUS, a Phase 2b trial, potentially pivotal, evaluating MaaT033 seeking to improve survival after allogeneic hematopoietic transplantation (HCT), THRASSA, a multicenter, open‑label paediatric/adolescent study evaluating MaaT013 in patients with ruxolitinib‑refractory or ruxolitinib‑intolerant gastrointestinal aGvHD Clinigen, MaaT Pharma’s strategic commercial partner for MaaT013’s Early Access Program and commercialization in Europe pending European Medicines Agency (EMA) approval, will host an Industry Symposium on advancing care for steroid-refractory gastrointestinal aGvHD Lyon, France, March 9, 2026 – 6:00pm CET – MaaT Pharma (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, today announced that clinical data and updates from key programs within its hemato‑oncology pipeline will be presented at the 2026 EBMT Annual Meeting, taking place March 22–25, 2026 in Madrid, Spain. An oral presentation, scheduled during the Presidential Plenary Session, will detail the final results, including overall survival data, from the Company’s lead asset MaaT013, which is currently under review by the European Medicines Agency (EMA) following the submission of a Marketing Authorization Application in June 2025. In addition, MaaT Pharma will present three poster communications, featuring: Key results from CHRONOS, a multicenter retrospective cohort study describing real‑world outcomes in third‑line acute gastrointestinal GvHD, and The study designs of two clinical trials (PHOEBUS and THRASSA – pediatric study announced in March 2025) advancing the Company’s therapeutic pipeline. With this broad clinical data presentation at the 2026 EBMT Annual Meeting, MaaT Pharma reaffirms its position in hemato‑oncology across the full care continuum of HCT and its commitment to improving outcomes for patients undergoing allogeneic transplantation. During this year’s Congress, Clinigen, MaaT Pharma’s strategic commercial partner for MaaT013’s Early Access Program and commercialization in Europe pending EMA approval, will host a dedicated symposium on Advancing Management of Steroid Refractory aGvHD with GI Involvement: From Unmet Need to a Potential Third Line Option. MaaT013 is currently under regulatory review and not yet approved. The symposium will be chaired by Florent Malard, MD, PhD, hematology professor at Saint-Antoine Hospital and Sorbonne University and Fabio Ciceri, MD, PhD, Associate Professor of Hematology, University Vita-Salute San Raffaele. It will also feature renowned hematology experts such as Zinaida Peric, MD, hematologist University of Rijeka (Croatia); Chair, GvHD Subcommittee, Transplant Complications Working Party, EBMT, Ernst Holler, Professor at University Medical Center Regensburg (Germany) and Jaime Sanz, MD, hematologist and coordinator of the Bone Marrow Transplant Unit at the University Hospital La Fe in Valencia (Spain). The details of the Symposium are below: Title: Advancing Management of Steroid Refractory aGvHD with GI Involvement: From Unmet Need to a Potential Third Line Option Date: Sunday, March 22, 2026 Time: 12:30 – 14:00 CET Room: N101–102 Professor Malard will also speak at a workshop session dedicated to the Current state of microbiota transplantation in allogeneic HCT, independently from any activities related to the Company, on Monday, March 23, 2026, from 11:

Plus, news about BrainEver, Clinigen, MaaT Pharma, Dyadic and Nektar Therapeutics.

Clinigen has appointed Paul Carter as Non-Executive Chair of its Board

Clinigen has appointed Nihad Hasagic as SVP for CLS

Job title: Metrology Technician (Pharmaceutical) Company: Clinigen Job description: About Clinigen and the Role: Clinigen is a rapidly growing global specialty pharmaceutical and services company... buildings Experience in the pharmaceutical or Bio-Tech industries Knowledge of ventilation and cleanroom filtration standards... Expected salary: Location: Malvern, PA Job date: Fri, 27 Jun 2025 22:25:36 GMT Apply for the job now!

UK Drug Shortages List

Der Pharmadienstleister Clinigen baut nach dem Delisting sein Portfolio aus. Die Integration der SSI Strategy soll die Marktposition durch ganzheitliche Beratung stärken.

Pratteln, Switzerland, January 6, 2025 “ Santhera Pharmaceuticals (SIX: SANN) announces the signing of an exclusive agreement with Clinigen Group to manage the supply and distribution of AGAMREE ® (vamorolone) in countries where the product is not otherwise commercially available. Santhera Pharmaceuticals and Clinigen Group announce that they have signed a Supply and Distribution Agreement for AGAMREE in countries where the product can currently not be commercially obtained via Santhera or one of its current distribution partners.

Clinigen obtained approval for Prolacta's "PreemieFort® Enteral Solution", a human milk-based fortifier, as an approved pharmaceutical product in Japan indicated for the "Nutritional management of neonates and infants presenting with weight gain failure such as very low birth weight...

Clinigenがプロラクタ社の「プリミーフォート®経腸用液」を日本で承認。超低出生体重児の栄養管理に新たな道を開く。未承認の技術を活用した医療革新の話題を掘り下げます。