FDA Approvals
Virtue Sirolimus-Eluting Balloon (SEB) for the treatment of coronary in-stent restenosis (ISR) secured breakthrough device designation from the FDA. Virtue SEB is a drug/device combination product delivering sustained-release bioabsorbable nanoparticle-encapsulated Sirolimus for preventing restenosis directly to the artery during balloon angioplasty, without the need for a coating.
Colon Cancer Screening without the Prep
Alex Ovadia, CEO of Check-Cap, talks about the company’s ingestible imaging capsule-based system for colorectal cancer screening.
Gene Editing Startups Fabricate Industrial-Grade CRISPR Tools
Porcine xenotransplantation research was halted in the 1990s because of the risk of transmitting porcine endogenous retrovirus (PERV) to patients during organ transplants. To help resurrect the field, genomic pioneer George Church, PhD, and researcher Luhan Yang, PhD, co-foundeed eGenesis, a company devoted to developing human-compatible organs, tissues, and cells. eGenesis is working to make porcine tissue PERV-free and as human-like as possible to enable life-saving medical interventions.
ABX464 as a Treatment for Ulcerative Colitis
An open-label study has found data that could support the use of ABX464 as a treatment for moderate to severe ulcerative colitis (UC). Investigators presented information from the ABX464-102 phase 2a study, which found that almost all patients demonstrated clinical response and nearly half were in clinical remission, at Digestive Disease Week 2019 in San Diego, CA
mRNA and Artificial Intelligence: An Interview with Anima Biotech’s Yochi Slonim
In the life sciences industry, there is a wide variety of directions that companies can go. Many high-profile biopharma companies have a focus on messenger RNA (mRNA), and some are broadening their horizons by taking an interest in artificial intelligence. One company, Anima Biotech, has a unique approach to both.
Reata’s drug, Bardoxolone, shows promising results for chronic kidney disease
Reata is in its ‘final pivotal study’ for its new drug, bardoxolone. In the trials, the drug has showed promising results to reverse kidney damage. Yahoo Finance sits down with the CEO of Reata, Warren Huff, who founded the company in 2002, to discuss the plans to launch the product in the near future.
Deep, transcranial magnetic stimulation for OCD
BrainsWay’s so-called depression helmet—which focuses powerful electromagnetic waves to stimulate and help rewire neurons firing deep within the brain—picked up its second clearance from the FDA last August, making it the first noninvasive device for obsessive-compulsive disorder.
Reata’s big test approaches
Reata Pharmaceuticals has shown that perseverance can pay off. Its lead project, bardoxolone, which is now focused on rare kidney diseases, is forecast to sell $1.3bn in 2024 after earlier flopping in a broader indication. The company should soon find out whether bardoxolone is approvable, with phase III data in the project’s first indication, Alport syndrome, due in the second half of the year. And Reata and analysts alike are confident after positive results from the phase II portion of the same study.
