Tag: cell 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 […]

Biotech, Industry

Genetic Engineering Across the Tree of Life

September 21, 2020

Via: Genetic Engineering and Biotechnology News

Industrial bioengineering is now using genetically modified microbes to produce a wide array of products at industrial scale, including everything from biofuels to nutraceuticals such as resveratrol. But despite the diversity of output, the primary organisms producing them are modified […]

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, 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

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 […]

Industry, Pharma

Phio Pharmaceuticals Reports Second Quarter 2020 Financial Results and Provides Business Update

August 12, 2020

Via: BioSpace

Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (INTASYL™) therapeutic platform, today reported its financial results for the quarter ended June 30, 2020 and provided a business […]

Cell and Gene Therapy, Industry

Standardizing Cell and Gene Therapy Remains Bioindustry Goal

August 3, 2020

Via: Genetic Engineering and Biotechnology News

For companies working on cell and gene therapies, preparing the reagents required for product development and scale-up can take lots of time and money. Stephen Gunstream, CEO, and his team at Teknova hope to change that. “We provide customers with […]

Industry, Vaccines

Research Roundup: Can Flu and Pneumonia Vaccines Prevent Alzheimer’s and More

July 31, 2020

Via: BioSpace

Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones. Flu and Pneumonia Vaccines Decrease Risk of Developing Alzheimer’s Two separate studies were presented at the Alzheimer’s Association International Conference (AAIC) 2020: […]

FDA, Regulations

U.S. FDA Approves Kite’s Tecartus™, the First and Only CAR T Treatment for Relapsed or Refractory Mantle Cell Lymphoma

July 24, 2020

Via: BioSpace

Kite, a Gilead Company (Nasdaq: GILD), today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Tecartus™ (brexucabtagene autoleucel, formerly KTE-X19), the first and only approved chimeric antigen receptor (CAR) T cell therapy for the […]