SAN CARLOS, Calif., Aug. 22, 2018 — In a Viewpoint paper published online today in Circulation Research, the Phase III CardiAMP Heart Failure Trial (CardiAMP-HF Trial) studying the investigational CardiAMP stem cell therapy from BioCardia®, Inc. (OTC: BCDA) was highlighted as an example of personalized medicine, with promising results from the first 10 patients in the roll-in cohort reported. The company believes this to be the first outcomes data published from any pivotal trial of a stem cell therapy for heart failure. The paper is authored by Peter Johnston, M.D., Eric Duckers, M.D., Ph.D., Amish Raval, M.D., Thomas Cook, Ph.D. and Carl Pepine, M.D. [Read more…]
California Cryobank And CBR Combine To Create A Leading Life Sciences Platform
LOS ANGELES, Aug. 6, 2018 — California Cryobank, the world’s leading donor sperm and donor egg bank, announced today that it has been acquired by GI Partners, a private equity investment firm, from leading healthcare investors Longitude Capital and NovaQuest Capital.
In a separate transaction, GI Partners has also completed its acquisition of Cord Blood Registry (CBR), the world’s largest stem cell collection and storage company, from AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG). [Read more…]
Former Stem Cell Patient Announces Foundation’s New Initiative to Guide Stem-Cell Companies, Clinics into FDA “RMAT” Process
Doug Oliver advised Congress on 21st Century Cures Act, leads foundation’s growing network of experts to help clinics pursue FDA approval
“I love what you’re doing and remember those early fateful days where I got you together with Senator Alexander … You reached out to me early on, and with that we’re helping hundreds of thousands, and eventually millions of people through your hard work.”
– Former U.S. Senate Majority Leader Bill Frist, M.D. [Read more…]
Steminent Announces Japan partner ReproCELL has PMDA Approval of CTN for Phase II Trial of Stemchymal® SCA in the Treatment of Spinocerebellar Ataxia in Japan
San Diego, CA, USA, August 1st, 2018 – Steminent Biotherapeutics Inc. (“Steminent” or “Company”) a private, clinical-stage cell-therapy company with offices in Taiwan, San Diego and Shanghai, is pleased to announce that the Clinical Trial Notification (“CTN”), submitted by their Japan partner; ReproCELL, to the Japan Pharmaceuticals and Medical Device Agency (“PMDA”) for a Stemchymal® SCA Phase II clinical trial for Polyglutamine Spinocerebellar Ataxia (“PolyQ SCA”) has been approved. This is another key milestone for Steminent’s international Stemchymal® SCA Phase II clinical development program with trials now moving ahead in Taiwan, US, and Japan. [Read more…]
Nohla Therapeutics Receives FDA Fast Track Designation for Dilanubicel for Allogeneic Cord Blood Transplant Patients
SEATTLE, Aug. 06, 2018 — Nohla Therapeutics, a leading developer of universal, off-the-shelf cell therapies for patients with hematologic malignancies and other critical diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to dilanubicel (NLA101) for patients with high-risk hematologic malignancies receiving an allogeneic cord blood transplant. Dilanubicel has already received PRIME designation from the European Medicines Agency, and Orphan Drug Designation from the FDA and European Commission. [Read more…]
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