Tag: gene therapy

Clinical Trials, Research and Development

Excision’s CRISPR gene editing therapy for HIV is heading into human testing after FDA clearance

September 17, 2021

Via: FierceBiotech

A CRISPR-Cas9 gene editing technology that has shown promise in clearing HIV from mice is headed into human testing. Excision BioTherapeutics will usher the CRISPR-based therapy EBT-101 into clinical trials after the FDA cleared an investigational new drug application, according […]

Cell and Gene Therapy, Industry

AbbVie bets big on a gene therapy for eye diseases

September 13, 2021

Via: Biopharma Dive

While estimates vary, AMD is thought to affect a large number of people. A study published in 2014, for instance, projected the patient population globally would hit 196 million in 2020 and grow to 288 million by 2040. Among those […]

Mergers and Acquisitions

Roche bets on T-cell therapies with Adaptimmune deal

September 8, 2021


The deal with see Adaptimmune receive $150m upfront, another $150m over the next five years and then milestone payments potentially exceeding $3bn in aggregate sales, as well as royalties. Unlike other leaders in next-generation cell therapies, the partners will use […]

Biotech, Cell and Gene Therapy, Industry

FDA halts tests of BioMarin drug amid heightened focus on gene therapy safety

September 7, 2021

Via: Biopharma Dive

The theoretical risk that gene therapy may cause cancer in humans has hung over the field for decades. Those worries resurfaced last year when a liver tumor was spotted in a patient who had received an experimental treatment for hemophilia […]

Cell and Gene Therapy, Industry

More trouble for Astellas as AT132 gene therapy trial is halted again

September 1, 2021

Via: Pharmaphorum

The ASPIRO trial of AT132 has been paused after abnormal liver function tests (LFTs) were seen in a patient receiving the gene therapy, and information on the adverse event has been shared with regulators, according to the drugmaker. ASPIRO was […]

Biotech, Industry

NSF Grant Awarded for Cellular Biomanufacturing Research

August 30, 2021

Via: Genetic Engineering and Biotechnology News

The National Science Foundation (NSF) awarded Rebekah Margaret Samsonraj, PhD, assistant professor in the department of biomedical engineering at the University of Arkansas, a $466,266 NSF grant for research on bioprocessing stem cell-derived therapeutics. The goal of the project is […]

Cell and Gene Therapy, Industry

Improving CAR-T cell therapy with more sensitive tumor identification

August 25, 2021

Via: FierceBiotech

CAR-T cell therapies, which involve engineering a patient’s own T cells to target and kill cancer cells bearing specific antigens, has shown strong results in blood disorders. But many patients still progress or relapse after initial remission, because tumor cells […]

Cell and Gene Therapy, Industry

Improving Stability for Gene Therapy Products

August 24, 2021

Via: Genetic Engineering and Biotechnology News

Recent interest in gene therapies and the genetic constructs on which they are based is causing a flurry of activity in facility construction and expansion. After they are manufactured doses must be stored, shipped, and stored again as they await […]

Cell and Gene Therapy, Industry

Cell, gene therapy company funding reaches new heights, despite setbacks

August 19, 2021

Via: Biopharma Dive

The amount of money flowing into cell and gene therapy development suggests investor confidence in the field’s future remains high, even as clinical, regulatory and commercial setbacks have hindered a number of companies, such as Bluebird bio, Biogen and Adverum […]

Cell and Gene Therapy, Industry

Innoforce Expands Cell and Gene Therapy Capabilities

August 17, 2021

Via: Contract Pharma

Innoforce Pharmaceuticals has opened a new advanced cell and gene therapy development facility in Hangzhou, China. Analytical development (AD) and process development (PD) represents a critical step towards providing services for potential clients in their cell and gene therapy product […]

Cell and Gene Therapy, Industry

Stem Cell Therapy Repairs Injured Tendons

August 17, 2021

Via: Genetic Engineering and Biotechnology News

Tendon injuries in sheep that were treated with stem cell grafts achieved, in just two months, a diameter and hardness similar to the original healthy tendon, according to the results of a study (“Adipose micro-grafts enhance tendinopathy healing in ovine […]

Cell and Gene Therapy, Industry

bluebird bio re-evaluates gene therapy strategy in ‘untenable’ European market

August 11, 2021

Via: Pharma Times

In a statement, the US biotech company’s president of severe genetic diseases Andrew Obenshain said bluebird will instead focus on the US market, highlighting the ‘challenges of achieving appropriate value recognition and market access for Zynteglo [betibeglogene autotemcel] in Europe’. […]