Cell Therapy Archives | Page 21 of 62

RoslinCT and Ayrmid Pharma Enter Into a Strategic Partnership to Manufacture FDA Approved Cell Therapy Omisirge® (omidubicel-onlv)

March 20, 2025 By Cade Hildreth, Founder & President Leave a Comment

Intent that RoslinCT is to perform technology transfer and commercial manufacture of Omisirge® at RoslinCT’s cell therapy manufacturing facility in Hopkinton, MA.

Omisirge® is a commercialized mismatched unrelated cell therapy derived from the youngest donor source and banked for ease of infusion for patients with hematological malignancies.

Garuda Therapeutics Closes $50 Million Series A-1 Financing to Advance Off-the-Shelf Blood Stem Cell Therapies

March 13, 2025 By BioInformant Team Leave a Comment

New funding will accelerate Garuda’s rapid growth and fund development of off-the-shelf hematopoietic stem cell (HSC) therapies for a multitude of severe and life-threatening diseases

CAMBRIDGE, Mass., March 04, 2025 — Garuda Therapeutics (Garuda), a biotechnology company creating off-the-shelf, HSC therapies for a multitude of blood disorders, today announced the successful completion of an approximately $50 million Series A-1 funding round. Investors included OrbiMed, Northpond Ventures and Cormorant Asset Management, with new strategic investment from Kyowa Kirin Co., Ltd., a Japan-based Global Specialty Pharmaceutical Company. [Read more…]

FDA Grants RMAT for ImmunityBio’s ANKTIVA® and CAR-NK in Reversal of Lymphopenia and Pancreatic Cancer Treatment

February 28, 2025 By Cade Hildreth, Founder & President Leave a Comment

ImmunityBio, a prominent biotechnology company, has made significant strides in cancer and immune-related therapies with its groundbreaking development of ANKTIVA® and CAR-NK (PD-L1 t-haNK). On February 27, 2025, the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation for these two promising treatments. This designation is pivotal for ImmunityBio, as it accelerates the development and approval process for ANKTIVA and CAR-NK in addressing lymphopenia caused by standard-of-care chemotherapy and radiotherapy, as well as in the treatment of multiply relapsed locally advanced or metastatic pancreatic cancer. [Read more…]

Cook MyoSite Announces Completion of Enrollment for the CELLEBRATE Study

February 12, 2025 By Cade Hildreth, Founder & President Leave a Comment

Pittsburgh, Pa., February 12, 2025 — Cook MyoSite today announced the completion of enrollment of the CELLEBRATE Study, a Phase III clinical trial evaluating the efficacy and safety of iltamiocel compared to a placebo in the reduction of stress incontinence episode frequency in adult female participants with persistent or recurrent stress urinary incontinence (SUI) despite previous surgical treatment. This milestone builds upon the significance of iltamiocel receiving the Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. Food and Drug Administration (FDA) which recognized the seriousness of this unmet need. [Read more…]

NecstGen Partners with Galapagos to Advance Decentralised CAR-T Cell Manufacturing in Europe

February 10, 2025 By Cade Hildreth, Founder & President Leave a Comment

Leiden, Netherlands, 10th February 2025 – NecstGen, a leading Contract Development and Manufacturing Organization (CDMO) dedicated to Cell and Gene Therapies, is proud to announce a strategic collaboration with Galapagos NV (Euronext & NASDAQ: GLPG), a biotechnology company with operations in Europe and the U.S. to support decentralized manufacturing of Galapagos’ candidate cell therapy products. The partnership underscores both NecstGen’s and Galapagos’ commitment to advancing innovative therapies and bridging the gap between the translation of research, to large clinical trials, and bring products to patients. [Read more…]