Pompano Beach, FL – August 11th, 2020 — BioStem Technologies, Inc. (OTC PINK: BSEM) a leading life sciences company specializing in the development and sale of perinatal tissue-based allografts for use in regenerative therapies, today announced that its subsidiary, Blue Tech Industries, Inc. (doing business as BioStem Life Sciences), has signed a Master Service Agreement with a new customer to manufacture the customer’s amniotic membrane platform for the next two years, in a deal estimated to be worth up to $2.4 million to BioStem. The agreement also allows the companies to initiate additional projects in the future. [Read more…]
Stem Cell News
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Stem Cell Treatment Now Available in the UK, as LifePlus Stem Cells Launches in London
July 21, 2020 — LifePlus Stem Cells is the first Stem Cell service in the UK to provide doctors and prescribers with quantifiable, quality assured autologous and allogeneic stem cells, with appropriate HTA and MHRA licenses.
Patients in the UK can now benefit from Stem Cell treatments prescribed as a medicine, which can be used for a wide range of conditions. [Read more…]
FDA Approves Two Emergency INDs for COVID-19 Outpatient Therapy
First Reported eIND Issued for Outpatient COVID-19 Therapy
Miami, FL (August 6, 2020) — Organicell Regenerative Medicine, Inc. (OTCBB: BPSR), a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, announced today that the U.S. Food and Drug Administration (FDA) approved two outpatient Emergency Investigational New Drug Applications (eINDs) for treating mild to moderate respiratory distress due to COVID-19. [Read more…]
Direct Biologics Receives FDA Approval to Initiate ‘EXIT COVID-19,’ a Phase II Investigational New Drug Trial with ExoFlo™
AUSTIN, Texas — Direct Biologics, LLC, is announcing that it has received approval from FDA that it may proceed with a Phase II trial under an Investigational New Drug (IND) application for the use of ExoFlo™, a bone marrow-derived extracellular vesicle and exosome product, in the treatment of COVID-19 associated Acute Respiratory Distress Syndrome (ARDS). The ExoFlo Infusion Treatment for COVID-19 (EXIT COVID-19) Associated ARDS trial will be a multi-center, double-blind, randomized, placebo-controlled clinical trial. [Read more…]
Vita Therapeutics Receives Orphan Drug Designation from FDA for Allogenic iPSC-based Therapy
BALTIMORE, July 23, 2020 — Vita Therapeutics, Inc. has received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for VTA-110, a novel regenerative therapy for the treatment of Duchenne’s Muscular Dystrophy (DMD).
VTA-110, is a potential first-in-class allogenic iPSC-based therapy that has shown the ability to repair and regenerate healthy muscle in preclinical studies and has the potential to benefit patients with DMD. [Read more…]
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