December 17, 2020, PITTSBURGH — Cook MyoSite, a biotechnology firm based in Pittsburgh, Pennsylvania, today announced that the U.S. Food and Drug Administration (FDA) has granted the Regenerative Medicine Advanced Therapy (RMAT) designation to Cook MyoSite’s investigational product, Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR), for treatment of women with persistent or recurrent stress urinary incontinence (SUI) following surgical treatment. [Read more…]
Stem Cell News
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I Peace’s GMP-grade iPSCs are key to manufacture Avery Therapeutics’ MyCardia™, a proprietary tissue-engineered heart graft developed to treat heart failure
TUCSON, Ariz. and PALO ALTO, Calif., Dec. 16, 2020 — Avery Therapeutics, a Tucson-based company dedicated to advancing tissue-engineered therapeutics to treat diseases and injuries to human muscle, and I Peace, Inc., a Palo Alto-based biotech startup developing, mass-manufacturing, and commercializing Nobel Prize-wining technology of induced pluripotent stem cells (iPSCs), announced a service agreement to advance cell therapy for heart failure. Under the agreement, I Peace will generate and supply GMP-grade induced pluripotent stem cells (iPSCs) and related services to Avery Therapeutics. Avery Therapeutics will use the iPSCs to derive cells used in the manufacturing of MyCardia™. [Read more…]
CILOA creates its new GMP-compliant production unit
The French biotech company Ciloa creates its new GMP-compliant production unit as part of the development of a new generation of exosome-based vaccines and therapeutic vectors.
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This first production unit is designed to meet GMP (Good Manufacturing Practices) standards, thereby ensuring the autonomy of Ciloa in the development of its biomanufacturing infrastructure and in the progress towards its future clinical studies.
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The technology developed by Ciloa uses exosomes, small nanovesicles capable of transporting therapeutic proteins, for the development of a new generation of treatments and vaccines, notably in Covid-19 disease.
Performance Cell Manufacturing, CDMO Division of VetStem Biopharma
San Diego based Performance Cell Manufacturing is the newly formed CDMO division of VetStem Biopharma
Poway, California, December 8, 2020. – Performance Cell Manufacturing (PCM), is the newly formed contract development and manufacturing organization (CDMO) division of VetStem Biopharma.
PCM was born from VetStem’s 15 years of experience with cGMP compliant cell therapy product development and manufacturing. PCM provides cell therapy development and cGMP contract manufacturing for companies for FDA phase 1 and phase 2 clinical trials. [Read more…]
Sentien Biotechnologies Does First Subject with Ex Vivo MSC Therapy Against COVID-19
Sentien Biotechnologies Does First Subject in a Phase 1/2 Trial of its Ex Vivo MSC Therapy Against Severe COVID-19 at the University of New Mexico Hospital.
LEXINGTON, MA, NOVEMBER 23, 2020 — Sentien Biotechnologies, Inc., a clinical-stage biotechnology company developing novel approaches to cell therapy, announced that the first subject has been enrolled in its Phase 1/2 study of SBI-101 for the treatment of severe COVID-19 at the University of New Mexico (UNM) Hospital. SBI-101, Sentien’s innovative cell-based therapy, is being evaluated in COVID-19 patients suffering from both acute respiratory distress syndrome (ARDS) and acute kidney injury (AKI) requiring renal replacement therapy (RRT). [Read more…]
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