Top

Tag: clinical trials


Cell and Gene Therapy, Industry, News

Catalent Appoints Open Innovation, Biologics, Cell and Gene Therapy VP

November 19, 2020

Via: Contract Pharma

Catalent has appointed Behzad Mahdavi, Ph.D., MBA, as Vice President of Open Innovation, Biologics, Cell and Gene Therapy. In this new role, Dr. Mahdavi will join a team of experts in Catalent’s Science and Technology Group that works with customers […]


Industry, News, Vaccines

Immune-Boosting Components Double the Effectiveness of Melanoma Vaccine Candidate in Phase II Trial

November 18, 2020

Via: Genetic Engineering and Biotechnology News

A vaccine created to prevent the recurrence of the deadly skin cancer melanoma is about twice as effective when patients also receive two components that boost the number and effectiveness of immune system dendritic cells (DCs), according to the results […]


Clinical Trials, Research and Development

New Technique Developed to Study Cell Types in Parkinson’s Disease

November 17, 2020

Via: Genetic Engineering and Biotechnology News

Parkinson’s disease (PD) is a progressive disorder that affects nerve cells in the brain responsible for body movement. When dopamine-producing neurons die, symptoms such as tremor, slowness, stiffness, and balance problems occur. Researchers at Carnegie Mellon University (CMU) have developed […]


Cell and Gene Therapy, Industry

Does Talaris’ Investigational Cell Therapy Have Potential to Be a ‘Pipeline in a Product’?

November 10, 2020

Via: BioSpace

Talaris Chief Executive Officer Scott Requadt sees FCR001, the company’s investigational cell therapy, as a potential pipeline in a product (an experimental treatment that could have multiple uses across a number of indications). In fact, it was that versatility of […]


Industry, Vaccines

BIO Chairman: FDA Vaccine Reviews Too Complex and Costly for States to Replicate

November 10, 2020

Via: BioSpace

Several states have pledged to review COVID-19 vaccines themselves, after U.S. Food and Drug Administration (FDA) Emergency Use Authorizations EUA), to ensure safety and efficacy. A robust review, however, is unlikely. In reality, if state reviews go forward, they most […]


Industry, Vaccines

Coronavirus vaccine frontrunner Pfizer delivers key trial data – here’s where the other vaccines stand

November 9, 2020

Via: CNBC

Numerous pharmaceutical companies are racing to complete clinical trials and become the first to successfully get U.S. approval for a vaccine to fight the coronavirus, which has infected more than 50.5 million people worldwide in 11 months. A safe and […]


FDA, Regulations

FDA Places New CMC Demands on bluebird’s Sickle Cell Treatment

November 5, 2020

Via: BioSpace

Shares of bluebird bio fell more than 17% in premarket trading after the company announced late Wednesday that its sickle cell disease gene therapy treatment will not be submitted to the U.S. Food and Drug Administration (FDA) for two more […]


Cell and Gene Therapy, Industry

Scientists use gene therapy to regenerate damaged optic nerve fibers

November 5, 2020

Via: Medical News

Scientists have used gene therapy to regenerate damaged nerve fibers in the eye, in a discovery that could aid the development of new treatments for glaucoma, one of the leading causes of blindness worldwide. Axons – nerve fibers – in […]


News

Samsung Biologics Establishes Partnership with China Biotech GeneQuantum Healthcare to Collaborate on ADC Development

November 2, 2020

Via: BioSpace

Samsung Biologics (207940.KS) has entered into a strategic partnership with GeneQuantum Healthcare, a China biotech company, to jointly develop an antibody drug conjugate (ADC) for the treatment of non-small-cell lung carcinoma (NSCLC), triple-negative breast cancer (TNBC), and other solid tumors. […]


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

Scientists Map Sensitivity of Thousands of Genes to Chemical Exposure

November 2, 2020

Via: Genetic Engineering and Biotechnology News

Scientists at the University of Massachusetts, Amherst, have used what they claim is an unprecedented objective approach to identify which genes and molecular pathways— including mechanisms involving aging, lipid metabolism, and autoimmune disease—are most sensitive to chemical exposure. Headed by […]


Manufacturing, Research and Development

AB2 Bio and WuXi Biologics Collaborate on Orphan Drug Manufacture

October 30, 2020

Via: Genetic Engineering and Biotechnology News

AB2 Bio, a Swiss clinical-stage biotech company developing therapies for the treatment of severe systemic autoinflammatory diseases, and WuXi Biologics agreed to collaborate to set up and accelerate commercial-scale manufacturing of Tadekinig alfa, AB2 Bio’s recombinant IL-18 binding protein. AB2 […]


Cell and Gene Therapy, Industry

Catalent to Acquire Bone Therapeutics’ Cell Therapy Mfg. Facility

October 29, 2020

Via: Contract Pharma

Catalent has signed an agreement with Bone Therapeutics to acquire its cell therapy manufacturing subsidiary, Skeletal Cell Therapy Support SA (SCTS), including all of its assets located in Gosselies, Belgium. Catalent will purchase the shares of SCTS, currently held by […]