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Category: Cell and Gene Therapy


Cell and Gene Therapy, FDA, Industry, Regulations

FDA decision on Bristol Myers cell therapy could come down to the wire

September 22, 2020

Via: Biopharma Dive

Celgene gained rights to ide-cel through a 2018 deal with Bluebird bio, the experimental therapy’s original developer. When Bristol-Myers made its bid to buy Celgene, the two sides couldn’t agree to the long-term value of ide-cel, the now-approved multiple sclerosis […]


Cell and Gene Therapy, FDA, Industry, Regulations

Emmecell exits stealth mode as FDA greenlights clinical trials of cornea cell therapy

September 22, 2020

Via: FierceBiotech

Corneal transplantation can help people who are losing their sight thanks to degenerating corneas, but it’s “probably the most aggressive surgery” that already highly trained corneal specialists do, said Roger Goldberg, M.D., a retinal surgeon. “It’s not a decision they […]


Cell and Gene Therapy, Industry, News

Culprit Behind Immunotherapy Resistance in Some Lymphomas Revealed

September 17, 2020

Via: Genetic Engineering and Biotechnology News

Cancer treatments can be unsuccessful due to malignant cells surviving radiation, chemotherapy, or by evading apoptosis. Now researchers from the University of Tsukuba in Japan, demonstrate how the protein Livin—an apoptosis inhibitor—allows some lymphomas to resist therapy, and how targeting […]


Cell and Gene Therapy, Industry

Improving Cell Therapy’s Supply Chain

September 8, 2020

Via: Genetic Engineering and Biotechnology News

Several elements of making cell therapies create significant obstacles in getting these treatments to more patients. “A main challenge for cell therapies—autologous or allogeneic—is cryopreservation in the supply chain,” says Simona Guidi, business development director at Rigenerand. “Products have a […]


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

City of Hope Scientists Use Two Powerful Immunotherapies to Eradicate Solid Tumors

September 2, 2020

Via: BioSpace

City of Hope scientists have combined two potent immunotherapies — an oncolytic virus and chimeric antigen receptor (CAR) T cell therapy — to target and eradicate solid tumors that are otherwise difficult to treat with CAR T therapy alone, according […]


Cell and Gene Therapy, Industry

Gene therapy: Novel targets for congenital blindness

September 2, 2020

Via: ScienceDaily

As many as 40,000 people in Germany suffer from retinitis pigmentosa. This hereditary disorder is characterized by loss of photoreceptors in the retina, and can be caused by mutations in many different genes. Depending on the nature of the underlying […]


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

Anticancer Immunotherapy Response Predicted Using New Imaging Tool

August 28, 2020

Via: Genetic Engineering and Biotechnology News

Scientists at the University of Bath have developed a diagnostic tool that can predict whether a cancer patient is likely to respond to immune checkpoint inhibitor therapy. The method uses an imaging technique, iFRET, to directly assess interaction between programmed […]


Cell and Gene Therapy, Industry

Collaboration aims to reduce time and cost of cell and gene therapy development

August 20, 2020

Via: EPM Magazine

The technology, which is being developed by MicrofluidX, could help manufacturers overcome major bottlenecks in the development of cell and gene therapies, as well as reduce the time and costs associated with bringing such treatments to market. Whilst cell and […]


Cell and Gene Therapy, Industry

Mesoblast scores FDA committee’s backing for cell therapy despite some early worries

August 14, 2020

Via: FiercePharma

Cell and gene therapy makers have to contend with a laundry list of concerns on the road to approval, including a complicated manufacturing process and often, some regulatory pushback. Facing what was expected to be an FDA firing line over […]


Cell and Gene Therapy, Industry

How a biotech CEO figured out Covid-19 surveillance testing for 50 companies with 12-hour turnaround times

August 14, 2020

Via: CNBC

When the Covid-19 pandemic struck the U.S., young biotech company Verve Therapeutics was just months away from a pivotal development: studies in animals of its gene-editing approach to lowering cholesterol that would lead it to be heralded as a potential […]


Cell and Gene Therapy, Industry

Passage Bio slapped with gene therapy clinical hold

August 13, 2020

Via: FierceBiotech

The FDA has placed a phase 1/2 trial of Passage Bio’s GM1 gangliosidosis gene therapy PBGM01 on clinical hold pending further assessment of the risks associated with its delivery device, delaying the start of the study until around the end […]


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

Immunotherapy Boosted to Eliminate Cancers in Mouse Model

August 12, 2020

Via: Genetic Engineering and Biotechnology News

Studies in mice by researchers at Washington University School of Medicine in St. Louis have shown how the effects of a standard immunotherapy drug can be enhanced by blocking a protein called TREM2, resulting in the complete elimination of tumors. […]