ORLANDO, Florida, March 31st, 2020 – Aspire Health Science, LLC (the “Company” or “Aspire”), an FDA registered manufacturing facility specialized in the development and manufacturing of cell-based therapies, is pleased to announce that it has filed its pre-IND (Investigational New Drug) meeting request with the U.S. FDA and Pre-CTA (Clinical Trial Application) with Health Canada. A complete briefing package accompanied the meeting requests. This initiates formal communications between Aspire and both the U.S. FDA and Health Canada regarding development of the Company’s cellular therapy, ACT-20 for the treatment of severe COVID-19 Pneumonia. [Read more…]

Coronavirus disease (COVID-19) is a global pandemic that is threatening the viability of healthcare systems worldwide. The virus responsible for the disease is also known as severe acute respiratory syndrome coronavirus 2 and abbreviated as SARS-CoV-2. The eruption started in China on December 29, 2019, and by March 2020, it had spread to at least 180 countries and territories worldwide. [Read more…]

Headquartered in Cleveland, Ohio, Athersys is a biotech company focused on the development of novel cell therapeutics. With acute respiratory distress syndrome (ARDS) identified as a leading cause of death in COVID-19 patients, Athersys is working fast to launch a pivotal trial of its MultiStem® cell therapy product for the treatment of this life-threatening condition. [Read more…]

• Pluristem Therapeutics expects to treat more patients in Israel in the near future

• It is in discussions with regulatory agencies in the U.S. and Europe to define its clinical strategy for COVID-19

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