News

3 10, 2022

Join Avance Biosciences™ at the Cell & Gene Meeting on the Mesa Oct 11-13, 2022!

2022-10-18T15:38:20+00:00

Avance offers a broad range of assay development services, including assay design, assay validation, sample testing, and technology transfer under GLP compliance to support IND-enabling and clinical studies. With decades of experience helping gene and cell therapy companies, Avance Biosciences™ has the...

Join Avance Biosciences™ at the Cell & Gene Meeting on the Mesa Oct 11-13, 2022!2022-10-18T15:38:20+00:00
20 09, 2022

Join Avance Biosciences™ at Biotech Boston Sept 27-30, 2022!

2022-09-22T16:00:08+00:00

Ensure the Success of Your Biological Drug Development - Avance Provides Assays to Support your Biopharmaceutical Development & Manufacturing - Avance Biosciences™ is a world-leading CRO specializing in GLP & GMP compliant biological assay development, assay validation, and [...]

Join Avance Biosciences™ at Biotech Boston Sept 27-30, 2022!2022-09-22T16:00:08+00:00
13 09, 2022

Kyverna Therapeutics’ $85 million series B financing reflects significant investor confidence in the science behind cell therapies

2024-07-10T19:49:38+00:00

Kyverna Therapeutics, a cell therapy company engineering a new class of therapies for serious autoimmune diseases, today announced it has closed an oversubscribed $85 million Series B financing round led by Northpond Ventures. Additional investors included the company’s founding investors Westlake Village BioPartners (“Westlake”), Vida Ventures, and Gilead Sciences (“Gilead”), with new investors RTW [...]

Kyverna Therapeutics’ $85 million series B financing reflects significant investor confidence in the science behind cell therapies2024-07-10T19:49:38+00:00
30 08, 2022

First allogeneic cell therapy candidate engineered to target cd19 for b-cell malignancies receives IND clearance, will proceed to clinical trials

2024-07-10T19:49:27+00:00

Century Therapeutics, an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology, announced today that the company has been notified by the U.S. Food and Drug Administration (FDA) that the Company’s ELiPSE-1 clinical study may proceed to assess CNTY-101 in patients with relapsed or refractory CD19 positive B-cell malignancies. CNTY-101 is [...]

First allogeneic cell therapy candidate engineered to target cd19 for b-cell malignancies receives IND clearance, will proceed to clinical trials2024-07-10T19:49:27+00:00
23 08, 2022

FDA approves the first gene therapy for people with beta-thalassemia who require regular red blood cell transfusions

2024-07-10T19:27:05+00:00

bluebird bio has announced the the U.S. Food and Drug Administration (FDA) has approved ZYNTEGLO® (betibeglogene autotemcel), also known as beti-cel, a one-time gene therapy custom-designed to treat the underlying genetic cause of beta‑thalassemia in adult and pediatric patients who require regular red blood cell (RBC) transfusions. “The FDA approval of ZYNTEGLO offers people with [...]

FDA approves the first gene therapy for people with beta-thalassemia who require regular red blood cell transfusions2024-07-10T19:27:05+00:00
9 08, 2022

How gene therapy can cure or treat diseases

2024-07-10T19:31:26+00:00

The genes in your body’s cells play a key role in your health. Indeed, a defective gene or genes can make you sick. Recognizing this, scientists have worked for decades on ways to modify genes or replace faulty genes with healthy ones to treat, cure, or prevent a disease or medical condition. [...]

How gene therapy can cure or treat diseases2024-07-10T19:31:26+00:00
28 06, 2022

Sana Biotechnology to expand its manufacturing, advance cell-based therapies in neurological disorders

2024-07-10T19:30:27+00:00

The University of Rochester Medical Center (URMC) and Sana Biotechnology have entered into an agreement which will allow Sana to expand its manufacturing footprint and create new job opportunities in Rochester. Sana, a company focused on creating and delivering engineered cells as medicines, also operates in Seattle, Cambridge, and South San Francisco. The company has programs [...]

Sana Biotechnology to expand its manufacturing, advance cell-based therapies in neurological disorders2024-07-10T19:30:27+00:00
10 05, 2022

FDA issues new draft guidelines on genome editing and CAR-T therapy

2024-07-13T13:28:34+00:00

On March 15th, 2022 the FDA is announcing the availability of two draft guidance documents: “Human Gene Therapy Products Incorporating Human Genome Editing,” and “Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products.” The draft guidance, “Human Gene Therapy Products Incorporating Human Genome Editing,” is intended to provide recommendations to sponsors [...]

FDA issues new draft guidelines on genome editing and CAR-T therapy2024-07-13T13:28:34+00:00
4 05, 2022

FDA fast tracks unique next-generation gene-edited therapy for sickle cell disease patients

2024-07-10T19:30:59+00:00

Graphite Bio is a clinical-stage, next-generation gene editing company harnessing the power of high-efficiency precision gene repair to develop therapies with the potential to treat or cure serious diseases. The FDA has just granted Fast Track Designation to GPH101 for the treatment of sickle cell disease (SCD). GPH101 is an investigational next-generation gene-edited autologous [...]

FDA fast tracks unique next-generation gene-edited therapy for sickle cell disease patients2024-07-10T19:30:59+00:00
16 02, 2021

Avance Biosciences™ Expanding Houston Campus

2024-07-10T19:33:13+00:00

HOUSTON, Feb. 16, 2021 /PRNewswire/ -- Avance Biosciences™, a leading CRO providing GLP/GMP-compliant assay development, assay validation, and sample testing services supporting biological drug development and manufacturing, announced today that its Houston facility, which successfully passed an inspection by the U.S. Food and Drug Administration in Oct 2018, is undergoing major expansion to handle rapidly growing demand for their services. [...]

Avance Biosciences™ Expanding Houston Campus2024-07-10T19:33:13+00:00
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