Tag: gene therapy

May 24, 2023

The Food and Drug Administration has delayed its review of a closely watched gene therapy for Duchenne muscular dystrophy by one month, taking more time to consider whether approval should be initially limited to children who are most likely to […]

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 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 8, 2023

Man’s aging best friend has a new treatment to dull osteoarthritis pain as the U.S. Food and Drug Administration (FDA) announced approval Friday of the first monoclonal antibody for dogs. Called Librela, the bedinvetmab shot controls pain from the most […]

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 1, 2023

Flatiron Health is collaborating with Sanofi to redesign the clinical trial experience for sponsors, sites, and patients in the therapeutic area of oncology. The multi-study collaboration will focus on improving clinical trial data acquisition, delivery, and quality through site-facing technology […]

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 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 11, 2023

A biotechnology company looking to alleviate a problem in cell and gene therapy production emerged from “stealth” mode on Tuesday, unveiling itself alongside $64 million in funding. Based in Philadelphia, VintaBio was founded by Junwei Sun and Shangzhen Zhou, two […]

April 10, 2023

Adoptive cell therapy (ACT) has become a promising immunotherapy tool to help treat advanced melanoma. The therapy, which harnesses immune cells collected from the patient’s own tumors, could provide a new treatment option to cancer patients, potentially bypassing radiation therapies […]

April 4, 2023

Freeline’s retrenchment adds to the growing list of reorganizations, job cuts and other strategic maneuvers young drugmakers have pursued amid a sharp downturn in the public markets. Already this year, at least 56 biotech companies have announced layoffs, according to […]

April 3, 2023

Cell and gene therapy clinical research is a field that holds promise for the treatment of many diseases. These therapies involve using living cells or genes to treat or prevent diseases and have the potential to revolutionize how we approach […]

March 29, 2023

Bluebird is now several months into launching two rare disease gene therapies for which it won FDA approval last fall. But its progress on that front was overshadowed Wednesday by news of the delay for the company’s sickle cell treatment, […]

March 20, 2023

Gene therapy is on the rise. As clinical success, innovation and investment in this area strengthens, Precedence Research predicts that the cell and gene therapy market will grow at a CAGR of 22 percent by 2030. Additionally, the FDA expects […]