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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 […]


FDA, News, Regulations

Trump health officials prepare to distribute coronavirus vaccine within 24 hours of OK from FDA

September 16, 2020

Via: CNBC

The U.S. government plans to transport a coronavirus vaccine to distribution sites across the U.S. within 24 hours after the Food and Drug Administration grants an emergency authorization or approval, senior administration officials said Wednesday. The government will use medical […]


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 […]


FDA, News, Pricing, Regulations

Democratic senators grill U.S. health officials on Trump interference in coronavirus vaccine process

September 9, 2020

Via: CNBC

Democratic senators on Wednesday grilled U.S. health officials about whether President Donald Trump is interfering in the development of potential coronavirus vaccines. National Institutes of Health Director Dr. Francis Collins and U.S. Surgeon General Dr. Jerome Adams testified before the […]


FDA, News, Regulations

FDA commish finding his feet, COVID-19, and chaotic communication hitting speedy approvals

August 26, 2020

Via: FierceBiotech

The FDA’s accelerated approvals program is on shaky ground after a series of surprise rejections, poor communication and COVID-19-focused staff. This is according to analysis by an anonymous FDA consultant out of regulatory firm Prevision Policy, speaking to analysts at […]


News

Parkinson’s Disease Treatment May Be Unlocked by Protein Structures

August 21, 2020

Via: Genetic Engineering and Biotechnology News

Scientists at the University of Bath have discovered a series of protein structures that are thought to be highly relevant to the onset of Parkinson’s disease (PD). Their findings, “A series of helical α-synuclein fibril polymorphs are populated in the […]


News

Prion Protein Antibodies Found to Be Naturally Occurring

August 18, 2020

Via: Genetic Engineering and Biotechnology News

Transmissible forms of neurodegenerative diseases that are always fatal sounds terrifying, and almost like science fiction. Unfortunately, prion disorders like Creutzfeldt-Jakob disease (CJD) are very real, but thankfully still extremely rare (only about 300 cases per year in the United […]


Clinical Trials, News, Research and Development

Cannabis Use during Pregnancy Linked to Increased Risk of Autism in Children

August 11, 2020

Via: Genetic Engineering and Biotechnology News

The results of what Ottawa researchers suggest is the largest study of its kind have found that children of mothers who reported using cannabis during pregnancy had a 50% increased risk of developing autism spectrum disorder (ASD), compared with children […]


News

AI Method Predicts Development of Drug-Resistant Phenotypes

August 5, 2020

Via: Genetic Engineering and Biotechnology News

All too often, artificial intelligence (AI) and machine learning get demonized in pop culture as being the harbinger of human armageddon. However, when we separate fact from science fiction, we find that AI is a powerful tool that can be […]


FDA, News, Regulations

FDA ad police’s warning letters have stalled during COVID-19, and that’s likely the new norm: expert

August 5, 2020

Via: FiercePharma

Enforcement letter output from the FDA’s advertising watchdog has slowed to zero during the COVID-19 pandemic. Only one letter from Office of Prescription Drug Promotion (OPDP) has been sent in 2020, and that was back in February, before the pandemic […]


News

As Clinical Trials Go Digital, Complexity Grows Along with the Risk to Data Integrity

August 4, 2020

Via: BioSpace

Data security risks are growing as more and more clinical trials embrace telemedicine and other digital technologies. The challenge is the complexity of securing a clinical trial ecosystem that may involve hundreds of data input points, trial sites, networks and […]


Cell and Gene Therapy, Industry, News

Immunotherapy Benefits Could Be Determined by ctDNA Test

August 4, 2020

Via: Genetic Engineering and Biotechnology News

The benefits of cancer immunotherapy are without question…for the subset of patients that it is applicable. While immunotherapy has been shown to shrink tumors and prolong survival for patients for whom other treatments have failed, only about 20–30% of patients […]