Tag: cell therapy

Cell and Gene Therapy, FDA, Industry, Regulations

How to gear up for more stringent gene and cell therapy regulations

April 1, 2021

Via: EPM Magazine

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 […]

Clinical Trials, FDA, Regulations, Research and Development

FDA green light for BMS, bluebird bio’s CAR-T therapy Abecma in multiple myeloma

March 30, 2021

Via: Pharma Times

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 […]

Cell and Gene Therapy, Industry

How Cancer Immunotherapy Gets a STING

March 29, 2021

Via: Genetic Engineering and Biotechnology News

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, […]

Cell and Gene Therapy, Industry

Drugmakers flock to Vineti’s fix for a cell, gene therapy problem

March 24, 2021

Via: Biopharma Dive

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 […]

Cell and Gene Therapy, Clinical Trials, Industry, Research and Development

Novel cancer-fighting gene therapy enters phase I clinical trial

March 18, 2021

Via: Medical News

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 […]

Cell and Gene Therapy, Industry

Sio Gene Therapies Provides Update on Cash Position and Major Upcoming GM1 Gangliosidosis Program Milestones

March 15, 2021

Via: BioSpace

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, […]

Cell and Gene Therapy, Industry

HepaTx, Namocell, and Takara Bio USA complete second phase of collaboration on single cell analysis for cell therapy to treat late-stage liver diseases

March 12, 2021

Via: BioSpace

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 […]

FDA, Regulations

Alkermes Announces FDA Orphan Drug Designation for Nemvaleukin Alfa for Treatment of Mucosal Melanoma

March 11, 2021

Via: BioSpace

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 […]

FDA, Regulations

FDA Grants Fast Track Designation to Spectrum Pharmaceuticals’ Poziotinib

March 11, 2021

Via: BioSpace

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) […]

Cell and Gene Therapy, FDA, Industry, Regulations

U.S. FDA Approves Yescarta for Relapsed or Refractory Follicular Lymphoma After Two or More Lines of Systemic Therapy

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 […]

FDA, Regulations

U.S. FDA Expands Approval of Pfizer’s LORBRENA as First-Line Treatment for ALK-Positive Metastatic Lung Cancer

March 4, 2021

Via: BioSpace

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 […]

Cell and Gene Therapy, FDA, Industry, Regulations

Immunocore gets FDA breakthrough nod for eye melanoma drug ahead of planned Q3 filing

February 19, 2021

Via: FierceBiotech

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 […]