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Clinical Supply Articles & Analysis: Older
31 news found
The production is performed at the hospital utilizing the Orgenesis Mobile Processing Units and Lab (OMPUL) to supply clinical grade batches. Glioblastoma Multiforme (GBM) is a highly aggressive cancer with an estimated five-year survival rate of 5%. ...
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 expanded its ...
Our LGR5 CAR-T cell has continued to deliver impressive results in pre-clinical testing. We submitted our pre-IND application in March this year and we are on track to file an IND application with the FDA in the second half of 2022. ...
The goal was to ascertain whether professional immunisers and healthcare workers found the clinical HD-MAP applicator usable and acceptable for vaccine delivery. Findings of the study were published in the Journal of Human Vaccines and Immunotherapeutics on 31 January 2022 in a paper titled, Usability, acceptability, and feasibility of a High-Density Microarray Patch (HD-MAP) ...
“Our new facility is designed for rapid development, scale-up and production for clinical supply, but our experienced teams provide quality oversight and regulatory guidance necessary to ensure success. ...
The increase was due to the expansion of the R&D workforce, and an increase in clinical studies, lab supplies, and contractor expenses. Net income was $84.4 million, or $0.19 per share, in the fourth quarter of 2021, compared to a net loss of $101.6 million, or ($0.41) per share, in the fourth quarter of 2020. ...
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 ...
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 or metastatic ...
For tivozanib, these milestones include initiation and continued enrollment of the Phase 3 TiNivo-2 clinical trial in advanced refractory RCC, and the presentation of data for the first-line cohort of the Phase 1b/2 DEDUCTIVE clinical trial in unresectable locally advanced or metastatic hepatocellular carcinoma (HCC) at American Society of ...
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. ...
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. ...
Through its acquisition of Henogen, Novasep's viral vector business, the company added more than 75,000 square feet of clinical and commercial manufacturing capacity with two locations in Seneffe and Gosselies, Belgium. As part of its strategic collaboration with the University of California, San Francisco (UCSF), Thermo Fisher has begun construction on a state-of-the-art cell ...
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. ...
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 reduces research study timelines. ...