To operate within the exosome market, it is vital to assess novel opportunities for product development. The most developed market segment involves research products that utilize stem cell exosomes, with these tools being sold to researchers in laboratories worldwide. However, exosomes can also be commercialized as therapeutic agents, diagnostic tools, and cosmeceuticals. Additionally, manufacturing technologies are being developed to support exosome production. [Read more…]
CRISPR Therapeutics and Vertex Pharmaceuticals Win RMAT for CTX001™
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CRISPR Therapeutics and Vertex Pharmaceuticals Have Been Awarded an FDA RMAT Designation for CTX001™ in the Treatment of Severe Hemoglobinopathies
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CTX001 has received Orphan Drug Designation from the U.S. FDA for transfusion-dependent beta thalassemia and from the European Medicines Agency (EMA) for sickle cell disease and transfusion-dependent beta thalassemia
ZUG, Switzerland and Cambridge, MA, May 11, 2020 — CRISPR Therapeutics (Nasdaq: CRSP) and Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. FDA RMAT designation to CTX001, an investigational, autologous, gene-edited hematopoietic stem cell therapy, for the treatment of severe sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT). [Read more…]
Stem Cell Manufacturing, From Past to Present
Without a doubt, stem cell manufacturing plays a critical role within the rapidly expanding stem cell sector. Progressing a cell-based therapeutic from pre-clinical stage production through later clinical stages and into commercial production requires scale-up.
Historically, the production of adequate quantities of stem cell based therapeutics has been a major challenge and bottleneck for the industry.
Thankfully, a growing number of technologies are now being adopted to support the production of emerging cell therapies. [Read more…]
MDimune Collaborating with Paracelsus Medical University for EV Therapeutics
Seoul, Korea, Apr 30, 2020 — MDimune Inc., a cell-derived vesicle (CDVs)-based therapeutics company with BioDrone® platform technology, announced on April 30th, 2020, the signature of a research collaboration agreement with Paracelsus Medical University (PMU, Salzburg, Austria). PMU will bring their experience to further the company’s global development goals.
Those in attendance from PMU were Herbert Resch, Professor and Rector; Michael Nake, Chancellor; Eva Rohde, Professor, Vice Rector and Director of GMP laboratory; and Mario Gimona, Associate Professor and Head of Production GMP. Those in attendance from MDimune were Shin Gyu Bae, Chief Executive Officer; Seung Wook Oh, Chief Scientific Officer; Tae Kee Jeong, Chief Financial Officer; and Hui-Chong Lau, Manager of the CMC team.
The agreement states that PMU will develop a process for producing CDV therapeutics at GMP-compliant scale as well as supply them for the pre-clinical study and the initial phase of human clinical study. PMU has also agreed to establish GMP-grade mesenchymal stem cell banks derived from umbilical cords for MDimune, which will then be used to produce CDVs required for various preclinical and clinical development. [Read more…]
Immunicum Wins RMAT for Ilixadencel, Its Dendritic Cell Immunotherapy Against Kidney Cancer
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Immunicum AB has received an FDA RMAT for Ilixadencel, its allogeneic dendritic cell immunotherapy for the treatment of metastatic renal cell carcinoma (mRCC).
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Ilixadencel is the 43rd FDA RMAT to be announced.
Immunicum AB (publ; IMMU.ST) has received and FDA Regenerative Medicine Advanced Therapy (RMAT) designation for the Company’s lead product candidate, ilixadencel, a cell-based, off-the-shelf immune primer for the treatment of metastatic Renal Cell Carcinoma (mRCC). [Read more…]
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