隶属于 else kröner-fresenius-stiftung
相关临床试验
52
2 进行中
药物批准
19
批准总数
监管机构
1
监管机构数
成立时间
1999
进行中（未招募）
1
1.9%
已完成
36
69.2%
尚未招募
1
1.9%
招募中
2
3.9%
终止
9
17.3%
Unknown
1
1.9%
撤回
2
3.9%
- Fresenius Kabi and AABB announced the 21st annual Blood Collectors Week, taking place September 6–12, 2026, to recognize blood collection professionals nationwide. - The initiative honors phlebotomists, apheresis operators, donor recruiters, technicians, drivers, and medical directors who maintain a safe, high-quality blood supply. - Nearly 200 blood collection facilities across the United States are expected to participate through recognition events, social media engagement, and employee appreciation activities. - The co-created and sponsored program highlights the technical skill and compassion required to link donors with patients in hospitals and communities.
- The FDA issued a warning letter to Fresenius Medical Care North America's Ogden, Utah facility on August 25, 2026, citing significant cGMP violations under 21 CFR Parts 210 and 211. - The most serious finding involved leaking Delflex Peritoneal Dialysis Solution bags, with 35 complaints covering about 156 bags from multiple batches attributed to holes caused by printing. - Fresenius assigned the lowest severity level to the leaks despite its own risk matrix identifying peritonitis as a potential harm, exposing patients to non-sterile products and potentially life-threatening complications. - The FDA has demanded an independent root-cause assessment and warned that inadequate correction could lead to seizure, injunction, or further regulatory action.
- Fresenius establishes Fresenius Ventures, a corporate venture capital unit with over €200 million in intended investment volume over the next five years. - The fund targets growth fields adjacent to Fresenius' biopharma, medtech, and care provision platforms, including new modalities, microbiome research, and digital care. - Thomas Michael Thestrup, formerly of Angelini Ventures, has been appointed to lead the new unit, bringing experience from Lundbeck, UCB, and Sunstone Capital. - The launch comes as Fresenius' biopharma division grew 43% in 2025 to €871 million, driven by biosimilar sales, while the broader generics sector faces tariff uncertainty.
- Dr Reddy's Laboratories received US FDA approval for its rituximab biosimilar, a monoclonal antibody targeting CD20 on B lymphocytes. - Fresenius Kabi holds exclusive US commercialization rights under an agreement with Dr Reddy's. - The biosimilar is indicated for B-cell malignancies including non-Hodgkin lymphoma and chronic lymphocytic leukemia, plus certain autoimmune conditions. - The product is already commercialized in India, the EU, the UK, and over 25 emerging markets, with additional approvals in Switzerland and Canada.
- ASCO and the Association for Clinical Oncology issued a critical drug supply warning after members reported severe disruptions to ifosfamide (Ifex) supply, with some practices holding less than a few weeks of inventory. - The shortage stems from a Baxter-contracted manufacturer in Germany halting production due to inspection-related issues, while alternate manufacturers Fresenius Kabi and Hikma have placed products on allocation. - No direct substitute exists for ifosfamide, which is used most often in pediatric sarcoma, testicular cancer, and lymphoma, and the shortage may persist until at least October 2026. - The FDA plans to temporarily allow importation of ifosfamide from overseas manufacturers, while guidance outlines supply, substitution, and conservation strategies organized into a three-tier, risk-based system.
- Glenmark Pharmaceuticals will launch its Potassium Phosphates Injection USP in the US market in March 2026, targeting the treatment and prevention of hypophosphatemia in adults and pediatric patients. - The injectable product will be available in three formulations including single-dose vials and pharmacy bulk packages, with the company claiming bioequivalence to the reference drug from Fresenius Kabi. - The launch represents Glenmark's strategic expansion into the US institutional injectable market, which generated approximately $50.7 million in sales for potassium phosphates injections in the past year. - The company emphasizes its commitment to providing quality and affordable alternatives to patients in need through this addition to their North American product portfolio.
- Fresenius Kabi and Phlow Corp. announced a groundbreaking collaboration to establish the first fully domestic end-to-end manufacturing of epinephrine injection, addressing chronic shortages of this critical emergency medicine. - The partnership combines Phlow's API production capabilities in Virginia with Fresenius Kabi's finished dose manufacturing, creating the first U.S.-based source for epinephrine active pharmaceutical ingredients. - Pending FDA approval, the domestically manufactured epinephrine injection could be available to U.S. hospitals by 2027, potentially serving as a scalable model for other essential medicines. - This initiative represents a strategic response to supply chain vulnerabilities and supports national health security by reducing dependence on foreign pharmaceutical manufacturing.
- Fresenius Kabi has entered into an exclusive licensing agreement with TQ Therapeutics to integrate proprietary cell selection technology into its Cue® Cell Processing System for automated T cell isolation. - The collaboration aims to create a point-of-care system that can isolate high-purity T cells from whole blood in under two hours, potentially enabling CAR-T therapy delivery closer to patients. - TQ Therapeutics' platform integrates blood collection, cell enrichment, genetic modification and reinfusion in a closed system designed to deliver personalized immunotherapy in under five hours. - The partnership builds on previous collaboration under the EU-funded EASYGEN project and represents a strategic effort to democratize cell therapy access by reducing manufacturing complexity and costs.
- Cambridge-based Cellular Origins closed an oversubscribed $40 million Series A funding round led by Johnson & Johnson Innovation to advance its Constellation robotic automation platform for cell and gene therapy manufacturing. - The company's technology addresses a critical bottleneck in the CGT sector, where current production systems serve fewer than 7% of eligible patients worldwide due to manufacturing limitations. - The funding will support commercial team expansion, platform development, and infrastructure scaling to enable production of hundreds of thousands of therapy doses while maintaining biological performance. - Strategic partnerships with industry leaders including Cytiva, Fresenius Kabi, Thermo Fisher Scientific, and Wilson Wolf validate the platform's commercial potential in addressing manufacturing challenges.
- Glenmark Pharmaceuticals' US subsidiary will launch generic Ropivacaine Hydrochloride injection in November 2025, offering a bioequivalent alternative to Fresenius Kabi's Naropin. - The long-acting anesthetic drug is indicated for producing local or regional anesthesia in surgical procedures for adults, with the reference product generating $20.9 million in sales over the past twelve months. - The generic version will be available in three single-dose vial strengths (40 mg/20 ml, 150 mg/30 ml, and 200 mg/20 ml), expanding Glenmark's injectable portfolio. - This launch reinforces Glenmark's commitment to providing quality and affordable medical alternatives to patients in need across the US market.
