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Spinogenix Secures DOD Grant To Study Lead Compound in hiPSCs from Patients with ALS

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Spinogenix Announces Grant by U.S. Department of Defense to Advance Novel Drug Candidate in Amyotrophic Lateral Sclerosis (ALS)

SAN DIEGO, Calif., Jan. 05, 2021 — Spinogenix, Inc. a preclinical-stage biopharmaceutical company developing novel small molecule drugs for neurological conditions, today announced that it will be collaborating with Dr. Rita Sattler at the Barrow Neurological Institute and Dr. Justin Ichida at the USC Keck School of Medicine on a grant awarded from the U.S. Department of Defense’s (“DOD”) Congressionally Directed Medical Research Programs (“CDMRP”) to evaluate its lead development candidate in ALS. [Read more…]

FDA Grants RMAT Designation for Cook MyoSite’s Investigational Autologous Muscle Derived Cells for Urinary Sphincter Repair

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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…]

I Peace’s GMP-grade iPSCs are key to manufacture Avery Therapeutics’ MyCardia™, a proprietary tissue-engineered heart graft developed to treat heart failure

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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

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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.

  • 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.
  • 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.

[Read more…]

Performance Cell Manufacturing, CDMO Division of VetStem Biopharma

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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…]

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