Category: Cell and Gene Therapy

May 22, 2023

Dystrophic epidermolysis bullosa is one of four main types of the disorder. Depending on the inheritance pattern, the condition can be severe and disabling, causing blisters anywhere on the skin from minor trauma and friction. The form Vyjuvek is cleared […]

May 17, 2023

Two and a half years ago, Nicole Paulk’s coworkers told her to start a company. The gene therapy researcher and then University of California, San Francisco assistant professor had just showed them data from mice studies testing a new kind […]

May 16, 2023

The Canadian Advanced Therapies Training Institute (CATTI) Inc. launched its first in-person training site at the University of Guelph through a partnership with OmniaBio Inc., CCRM and the university. The training program, to begin in summer 2023, will cater to […]

May 16, 2023

Diseases of the eye have been a popular target for gene therapy development, due in part to the potential for efficient delivery via injection as well as the lower risk of dangerous immune responses. Luxturna, the first gene therapy for […]

May 15, 2023

Life Biosciences, a biotechnology company, and Forge Biologics, a genetic medicines manufacturing organization, announced on May 8, 2023 that they are in a manufacturing partnership to help advance Life Bio’s partial epigenetic reprogramming platform to further address aging-related diseases, according […]

May 12, 2023

A group of Food and Drug Administration advisers narrowly supported approving what could be the first gene therapy for Duchenne muscular dystrophy in a meeting Friday, clearing the way for the agency to make a closely watched decision later this […]

May 11, 2023

Cellular Origins, a TTP Company focused on enabling scalable, cost-effective, and efficient manufacture of cell and gene therapies (CGTs), entered into a collaborative partnership with ScaleReady, a joint venture between Bio-Techne, Fresenius Kabi and Wilson Wolf that brings together process […]

May 10, 2023

Food and Drug Administration scientists evaluating what could be the first gene therapy for Duchenne muscular dystrophy appear skeptical of the treatment’s benefit, adding to questions about its approval prospects days before a crucial regulatory meeting. On Friday, the FDA […]

May 8, 2023

OBiO Technology Corp., a provider of gene and cell therapy-focused biotechnology, entered into a strategic commercial manufacturing collaboration with Chinagene, a developer of clinical genetic diagnosis, and gene therapy drugs. Under the agreement, OBiO will provide contract development and manufacturing […]

May 5, 2023

While radiopharmaceuticals can be difficult to manufacture, they are an attractive way to more selectively direct radiation to tumor cells while sparing healthy tissue. Prostate cancer in particular has been a target of choice for radiopharmaceutical developers looking to add […]

May 3, 2023

Forge Biologics, a manufacturer of genetic medicines, will collaborate with Labcorp, a global life sciences company, on gene therapy development and manufacturing. Under the alliance, gene therapy clients will have access to manufacturing capabilities, drug development services, and coordinated scientific […]

May 3, 2023

Since the first FDA approval in 2017, chimeric antigen receptor T-cell (CAR-T) therapy has garnered excitement as a potentially curative option for hard-to-treat blood cancers (1). In this therapy, T cells are genetically engineered to recognize specific tumor-surface antigens. When […]

May 2, 2023

Once a latecomer to cell therapy research, J&J has established itself as a major player in recent years. A 2017 licensing deal with Chinese drug developer Legend Biotech yielded Carvykti, which has since become one of only two cell therapies […]

April 26, 2023

The U.S. Food and Drug Administration on Tuesday approved a new drug for people who have a rare, inherited type of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease. The medication, toferson (Qalsody), targets a mutation in the […]

April 26, 2023

The application, which includes a request for priority review, is specifically for lovotibeglogene autotemcel (lovo-cel) to treat SCD patients aged 12 years and older who have a history of painful complications associated with the disease. Affecting approximately 100,000 people in […]

April 24, 2023

The U.S. Food and Drug Administration approved Omisirge (omidubicel-onlv), a substantially modified allogeneic cord blood-based cell therapy, to cut the risk of infection in patients with blood cancer following a myeloablative treatment, such as radiation or chemotherapy. Omisirge is administered […]

April 21, 2023

GenSight is facing another setback and a dwindling cash pile at an unfortunate time. A market downturn has made it difficult for drug developers to raise money by selling shares. For GenSight to continue its clinical work, it will likely […]

April 19, 2023

Omisirge is specifically indicated for individuals aged 12 years and older who are planned for umbilical cord blood transplantation following a myeloablative conditioning regimen, such as radiation or chemotherapy. Stem cell transplantation is a common treatment for blood cancers, which […]

April 19, 2023

The cancer cell therapy Carvykti dramatically outperformed standard drugs in a late-stage clinical trial testing its use in earlier treatment of the blood cancer multiple myeloma, according to data from a study abstract that was briefly posted online Tuesday. The […]

April 17, 2023

Today, the U.S. Food and Drug Administration approved Omisirge (omidubicel-onlv), a substantially modified allogeneic (donor) cord blood-based cell therapy to quicken the recovery of neutrophils (a subset of white blood cells) in the body and reduce the risk of infection. […]