Tag: cell therapy

April 1, 2021

In January 2020, the US Food and Drug Administration (FDA) published a series of seven guidances regarding cell and gene therapy. These have not come too soon, given some much-publicised regulatory rejections. For example, the FDA turning down the Biologics […]

March 30, 2021

Abecma (idecabtagene vicleucel; ide-cel) has been cleared for use in adult patients with relapsed or refractory multiple myeloma, after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody. In the […]

March 29, 2021

The innate immune system scans for signs—such as misplaced genetic material—that a pathogen or dangerous mutation could cause disease. When DNA is found in areas of the cell other than the nucleus, which can occur due to viruses or cancer, […]

March 24, 2021

The cell and gene therapy field hit major milestones over the last few years. In the summer of 2017, the Food and Drug Administration approved a first-of-its-kind cellular medicine from Novartis for a hard-to-treat form of leukemia. Less than two […]

March 18, 2021

Researchers from the MDC and Charité have developed a new gene therapy based around a special T-cell receptor that helps the immune system effectively recognize and fight cancer cells. The safety of the novel therapy is now being tested on […]

March 15, 2021

Sio Gene Therapies Inc. (NASDAQ: SIOX), a clinical-stage company focused on developing gene therapies to radically transform the lives of patients with neurodegenerative diseases, today announced that it had $120.9 million in cash and cash equivalents as of March 12, […]

March 12, 2021

HepaTx Corporation, Namocell Inc., and Takara Bio USA, Inc. (TBUSA) announced successful completion of the second phase of their collaboration on single cell analysis of hepatocyte-like cells (iHeps) differentiated from adipose tissue-derived stromal cells (ASCs) using Namocell’s Single Cell Dispensers […]

March 11, 2021

Alkermes plc (Nasdaq: ALKS) today announced that nemvaleukin alfa (“nemvaleukin”, formerly referred to as ALKS 4230), the company’s investigational engineered interleukin-2 (IL-2) variant immunotherapy, has been granted orphan drug designation for the treatment of mucosal melanoma by the U.S. Food […]

March 11, 2021

Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for poziotinib for the treatment of non-small cell lung cancer (NSCLC) […]

March 8, 2021

Kite, a Gilead Company (Nasdaq: GILD), today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Yescarta (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or […]

March 4, 2021

The U.S. Food and Drug Administration (FDA) approved Pfizer Inc.’s (NYSE: PFE) supplemental New Drug Application (sNDA) for LORBRENA (lorlatinib), expanding the indication to include first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). LORBRENA […]

February 19, 2021

Immunocore has received FDA breakthrough-therapy designation for tebentafusp in unresectable or metastatic uveal melanoma. The British biotech snagged the status ahead of a planned filing for FDA approval in the third quarter. Tebentafusp is a bispecific TCR molecule designed to […]