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Clinical Trials Supply Articles & Analysis
31 news found
“Orgenesis, through its newly formed POCare services subsidiary, has commenced clinical grade production, in collaboration with Hospital Infantil Universitario Niño Jesús in Madrid for the supply of clinical-grade batches of the cell-based product intended for intravenous administration. ...
Carrick Therapeutics, an oncology-focused biopharmaceutical company discovering and developing highly differentiated therapies, and the Menarini Group ("Menarini"), a privately-held, leading international pharmaceutical company, today announced a clinical trial collaboration and supply agreement. This agreement covers the execution of a Phase 2 ...
IO-108 is being studied as a monotherapy and in combination with select anti-PD-1 antibodies in multiple expansion cohorts of solid tumors Clinical supply agreement with Regeneron accelerates Immune-Onc’s solid tumor clinical development program Immune-Onc Therapeutics, Inc. ...
Clinical site initiation visits to train clinicians, nurses, coordinators, and pharmacists are underway, after which sites will be activated and the Flamingo-01 Phase III clinical trial will commence. ...
Waisman Biomanufacturing has entered an agreement with BriaCell to manufacture clinical supplies for BriaCell’s anticipated clinical trial in advanced prostate cancer. ...
Utilizing its custom HQ plasmid offering which, being manufactured to the principles of GMP, serves as a phase-appropriate solution for early clinical trials, Ziphius Vaccines will benefit from accelerated timelines without compromising on quality. Charles River, with the acquisitions of Cognate BioServices, Cobra Biologics, and Vigene Biosciences in 2021, has ...
Highlights Melbourne-based contract development and manufacturing organisation Cell Therapies will manufacture Carina Biotech’s LGR5 CAR-T cells for a first-in-human clinical trial for patients with advanced colorectal (bowel) cancer. Carina’s CAR-T cells are targeted at LGR5, a cancer stem cell marker that is highly expressed on colorectal ...
Australian biotechnology company, Vaxxas Pty Ltd (Vaxxas), in collaboration with the University of Sydney Institute for Infectious Diseases, Faculty of Medicine and Health, has completed a study assessing the usability and acceptability of its novel High-Density Microarray Patch (HD-MAP) to administer vaccines. The HD-MAP is Vaxxas’ proprietary vaccine patch technology, representing a ...
Matica Biotechnology, Inc. (Matica Bio), a contract development and manufacturing organization (CDMO) specializing in the clinical and commercial production of cell and gene therapies, today announced the opening of its new 45,000-square-foot facility dedicated to the production of viral vectors and cell-based products used in cell and gene therapies, vaccines, oncolytic therapies and other ...
Senseonics Holdings, Inc. (NYSE American: SENS), a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, today reported financial results for the quarter and full year ended December 31, 2021. Recent Highlights & Accomplishments: Received approval from the Food and Drug ...
NiKang Therapeutics Inc. (“NiKang”), a clinical stage biotech company focused on developing innovative small molecule oncology medicines to help patients with unmet medical needs and AVEO Oncology (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company (“AVEO”) , today announced that they have entered into a clinical ...
These milestones position us well for a potential registrational trial that is expected to start in 2023. In addition, we completed the Phase 1 clinical trial in healthy volunteers for AV-380 and expect to present results in mid-year 2022 and plan to initiate the Phase 1b clinical trial for this program in cancer ...
AVEO Oncology (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company, today announced that it has entered into a clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany to evaluate ficlatuzumab in combination with ERBITUX® (cetuximab), an EGFR-targeted antibody, in patients with recurrent ...
GI Innovation, Inc., (CEO, Jun Ho Hong) announced that GI Innovation signed a clinical supply collaboration agreement with global biopharmaceutical company AstraZeneca for development of GI-101 and Imfinzi® combination therapy. Under this agreement, GI Innovation and AstraZeneca will conduct a clinical trial assessing ...
GI Innovation licensed out main pipeline, immuno-oncology GI-101 (Simcere China) and allergic disease treatment GI-301 (Yuhan Pharm.) in non-clinical stage value of 2.3 trillion won and currently each pipeline is progressing global clinical 1/2 phase and domestic clinical 1 phase. In particular, GI Innovation recently unveiled the progress of ...
We plan to initiate a Phase 2b clinical trial for EVX-01 in melanoma by the end of 2021 in collaboration with Merck and initiate a Phase 2b clinical trial of EVX-02, in conjunction with our third product candidate, EVX-03, in Q2 2022. ...
To accelerate preclinical development for biologic drug developers, Thermo Fisher recently introduced its enhanced Quick to Clinic solution, designed to help biopharma companies reach Phase I/First-In-Human trials and file for Investigational New Drug (IND) review in as little as 13 months from transfection. ...
Matica Biotechnology, Inc, (Matica Bio) a contract development and manufacturing organization (CDMO) specializing in the clinical and commercial production of cell and gene therapies, today announced a joint research agreement (JRA) with Sartorius, a leading international partner of the biopharmaceutical industry. Under this agreement, Matica Bio and Sartorius will work on a number of studies ...
Endpoint Clinical, the leader in global interactive response technology (IRT®) for clinical trials, and Berlinger & Co. ...
endpoint Clinical, the leader in global interactive response technology (IRT®) for clinical trials, and THREAD, a leading technology and service provider enabling decentralized clinical trials (DCT), have announced their partnership to offer sponsors and sites a solution that simplifies DCT operations and ...