Miami, FL (May 27, 2020) – Organicell Regenerative Medicine, Inc. (OTCBB:BPSR), a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, announced today a health update for two critically ill COVID-19 patients who were treated at Landmark Hospital in Athens, GA with the Company’s Organicell Flow product. These patients were treated under the two recently approved Emergency Compassionate Use Investigational New Drug applications (eINDs) by the U.S. Food and Drug Administration (FDA). [Read more…]
Nucleus Biologics Unveils World’s First Online Portal for Instantaneous Custom cGMP Cell Culture Media Configuration
SAN DIEGO, May 27, 2020 — Nucleus Biologics, a leader in precision cell culture, today announced the availability of NB-Lux™, an online configuration and ordering platform for cell culture media. Designed for developers of cell therapies, NB-Lux™ speeds formulation development by providing real time pricing for cGMP grade media in lot sizes from two liters to 2000 liters. [Read more…]
I Peace, Inc. Introduces Clinical-Grade iPS Cell Custom Manufacturing Service
PALO ALTO, Calif., May 15, 2020 — I Peace, Inc. (CEO: Koji Tanabe), a Palo Alto-based biotech start-up focusing on Nobel Prize-wining technology “induced pluripotent stem cell (iPSC)” began manufacturing clinical-grade iPSCs. We are now officially taking orders for custom manufacturing of clinical-grade iPSCs from institutions around the world.
On March 11, 2020, the company received a license to manufacture clinical-grade cells from Japan’s Ministry of Health, Labour and Welfare for its cell manufacturing facility located in Kyoto, Japan. [Read more…]
FDA Approves Two Emergency INDs to Administer Organicell Flow for COVID-19
First Patients treated with Organicell Flow through “Emergency Single Patient Compassionate Use” designation
MIAMI, May 19, 2020 — Organicell Regenerative Medicine, Inc. (OTCBB:BPSR), a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, announced today that on May 11, 2020, the U.S. Food and Drug Administration (FDA) authorized two Emergency Compassionate Use Investigational New Drug applications (eINDs), each for a single patient severely ill from COVID-19. These critical patients have received immediate administration of Organicell Flow. [Read more…]
Mesoblast to Enroll 300 Patients in COVID-19 Trial of Stem Cell Therapy Remestemcel-L
Phase 2/3 Randomized Controlled Trial of Remestemcel-L in 300 Patients With COVID-19 Acute Respiratory Distress Syndrome Begins Enrollment
NEW YORK, April 30, 2020 — Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in cellular medicines for inflammatory diseases, today announced a Phase 2/3 randomized, placebo-controlled trial to rigorously confirm whether its allogeneic mesenchymal stem cell therapy remestemcel-L provides a survival benefit in moderate/severe acute respiratory distress syndrome (ARDS) due to COVID-19 has commenced enrollment. [Read more…]
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