Top

Category: Industry


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 […]


Industry, Vaccines

Moderna says it will begin developing a vaccine for seasonal flu

September 17, 2020

Via: CNBC

Biotech firm Moderna said Thursday it will begin developing a vaccine for the influenza season. “We are announcing that we are increasing our investment in vaccines and we will develop a seasonal flu vaccine given the unmet need for highly […]


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 […]


Industry, Vaccines

Automation a Key Focus for Moderna’s COVID-19 Vaccine Contractor

September 15, 2020

Via: Genetic Engineering and Biotechnology News

Moderna hired Lonza to make its COVID-19 vaccine in May. Initially, the CDMO will manufacture the vaccine active ingredient—an mRNA molecule in lipid nanoparticles—at plants in the United States and Switzerland. However, the firms plan to establish additional production suites […]


Industry, News, Pharma

Timber Pharmaceuticals Receives Notice of Allowance from U.S. Patent and Trademark Office for BPX-01 and BPX-04

September 15, 2020

Via: BioSpace

Timber Pharmaceuticals, Inc. (“Timber” or the “Company”) (NYSE American: TMBR), a biopharmaceutical company focused on the development and commercialization of treatments for orphan dermatologic diseases, today announced that it has received a formal notice of allowance from the U.S. Patent […]


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 […]


FDA, Industry, Regulations, Vaccines

FDA Action Alert: Possible COVID-19 Action and Mallinckrodt’s Terlipressin

September 8, 2020

Via: BioSpace

It’s entirely possible that what we will be seeing most from the U.S. Food and Drug Administration (FDA) for the month of September is related to treatments and vaccines for COVID-19. In general, the vaccines probably will not have actionable […]


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 […]


Industry, Pharma

Drug Targets Identified More Discerningly

September 1, 2020

Via: Genetic Engineering and Biotechnology News

Experimental drugs face steep odds. According to the Pharmaceutical Research and Manufacturers of America (PhRMA), out of every 5,000 to 10,000 compounds that enter the discovery and development pipeline, just 5 enter clinical trials, and only 1 receives approval. Other […]