Press Releases Archives | Page 71 of 116

Direct Biologics Receives FDA Approval to Proceed with Second ExoFlo IND for Post-Acute COVID-19 Syndrome and Chronic Post-COVID-19 Syndrome

June 9, 2021 By Cade Hildreth, Founder & President Leave a Comment

Extracellular Vesicle Isolate Product ExoFlo Shows Strong Potential to Treat COVID-19, Post-Acute COVID-19 Syndrome, and Chronic Post-COVID-19 Syndrome
60-patient trial to be conducted nationally at ambulatory infusion sites

AUSTIN, Texas, June 9, 2021 – Direct Biologics, a market-leading innovator and cGMP manufacturer of regenerative biologic products, announced today that it has received FDA approval to initiate a Phase I/II trial under an Investigational New Drug (IND) protocol for the use of ExoFlo™ in the treatment of Post-Acute COVID-19 Syndrome. This trial is Direct Biologics’ second approved IND, and it represents the first IND ever approved by FDA for the use of extracellular vesicles (EVs) to treat Post-Acute COVID-19 syndrome, Chronic Post-COVID-19 syndrome, or any post-viral syndrome. [Read more…]

The Generate Life Sciences Family of Companies Grows With the Addition of the Cell Care Group of Cord Blood Banks

June 7, 2021 By Cade Hildreth, Founder & President Leave a Comment

The acquisition provides the companies with shared scientific knowledge and resources, leading to a stronger foundation for advancing newborn stem cell research.

LOS ANGELES, June 2, 2021 — Generate Life Sciences (Generate) today announced that it has acquired the Cell Care international cord blood banking group (Cell Care), which comprises Cell Care in Australia, along with Insception Lifebank and Cells for Life in Canada.* [Read more…]

I Peace’s cell manufacturing facility “Peace Engine Kyoto” receives third-party certification as US cGMP compliant: the facility now meets the standard for both the US and Japanese markets

May 25, 2021 By Cade Hildreth, Founder & President Leave a Comment

Palo Alto, California, May 25, 2021 – I Peace, Inc. (CEO: Koji Tanabe), a Palo Alto-based biotech start-up focusing on Nobel Prize-winning technology “induced pluripotent stem cells (iPSCs)” received a third-party certification as US FDA cGMP compliant for its manufacturing facility “Peace Engine Kyoto,” in Kyoto Japan. Peace Engine Kyoto is owned and managed by its sole subsidiary I Peace, Co. Ltd. The facility was awarded a permit in 2020 by Japan’s Ministry of Health, Labour, and Welfare to manufacture specific cell-based products. [Read more…]

Organicell To Present Results Of Zofin™ Clinical Studies At The International Society Of Cell And Gene Therapy Annual Meeting

May 25, 2021 By Cade Hildreth, Founder & President Leave a Comment

Miami, FL (May 25th, 2021) – Organicell Regenerative Medicine, Inc. (OTCMKTS: BPSR), a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, today announced that the Company will be presenting at the annual meeting of the International Society of Cell and Gene Therapy (ISCT) taking place on May 26-28, 2021. [Read more…]

RoosterBio Releases RoosterGEM™, Cell and Gene Therapy’s First Complete Transduction Medium

May 21, 2021 By Cade Hildreth, Founder & President Leave a Comment

RoosterGEM™, a complete genetic engineering medium, empowers product developers to realize up to four-fold increased transduction efficiency in primary cells, and achieve a greater than 50% reduction in overall gene transfer cost.

Frederick, MD, May 20, 2021 – RoosterBio Inc., a leading supplier of human mesenchymal stem/stromal cell (hMSC) working cell banks and hMSC bioprocess systems for cell and gene therapy product developers, today announced the launch of its product RoosterGEM™, a stand-alone, complete gene transfer medium that is optimized to remove key challenges in primary cell genetic modification. [Read more…]

Extracellular Vesicle Isolate Product ExoFlo Shows Strong Potential to Treat COVID-19, Post-Acute COVID-19 Syndrome, and Chronic Post-COVID-19 Syndrome

60-patient trial to be conducted nationally at ambulatory infusion sites

The acquisition provides the companies with shared scientific knowledge and resources, leading to a stronger foundation for advancing newborn stem cell research.

RoosterGEM™, a complete genetic engineering medium, empowers product developers to realize up to four-fold increased transduction efficiency in primary cells, and achieve a greater than 50% reduction in overall gene transfer cost.