Globally, companies have deployed an impressive range of business models for exploiting iPSC technology platforms. To date, iPSCs have found applications within academic research, drug discovery, toxicology testing, cell therapy, personalized medicine, disease modelling, industrial-scale manufacturing, biobanking, clean-meat production, and beyond. [Read more…]
Direct Biologics Receives FDA Approval to Proceed with Second ExoFlo IND for Post-Acute COVID-19 Syndrome and Chronic Post-COVID-19 Syndrome
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Extracellular Vesicle Isolate Product ExoFlo Shows Strong Potential to Treat COVID-19, Post-Acute COVID-19 Syndrome, and Chronic Post-COVID-19 Syndrome
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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
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
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
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…]
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