In an unexpected decision, the Food and Drug Administration rejected Sarepta Therapeutics’ experimental drug for Duchenne muscular dystrophy, issuing on Monday a Complete Response Letter to the rare disease biotech. According to Sarepta, the agency cited in its refusal infection risk tied to the drug’s delivery as well as preclinical signs of kidney toxicity. Called
It is evident that remote field systems have the potential to greatly advance in vitro tissue engineering. However, the convergence of magnetic, optical, and acoustic technologies with in vitro tissue engineering is a relatively new development and, as a result, many studies exist only in the academic sphere and are far from disrupting the clinical
The U.S. Food and Drug Administration (FDA) today granted accelerated approval to entrectinib, a treatment for adult and adolescent patients whose cancers have the specific genetic defect, NTRK (neurotrophic tyrosine receptor kinase) gene fusion and for whom there are no effective treatments. “We are in an exciting era of innovation in cancer treatment as we
When the mice brain cells glowed, the researchers knew they were onto something. The study, from a team at Emory University School of Medicine, Atlanta Veterans Affairs Medical Center and Tzu Chi University, announces a novel, non-invasive, regenerative method called optochemogenetics that could improve stroke recovery (J. Neuroscience10.1523/JNEUROSCI.2010-18.2019). The second leading cause of death worldwide, according to the World
Source https://www.liebertpub.com/doi/pdf/10.1089/ten.teb.2018.0325 To this day, tissue reconstruction and replacement to address extensive tissue defects due to trauma, tumor resection, genetic and/or chronic diseases, or excessive debridement present a major clinical challenge. Traditional reconstructive techniques most commonly utilize autologous tissue. Undoubtedly, autologous composite tissue transfers or ‘‘flaps,’’ skin grafts, as well as the harvesting of bone
Source Global Data Gene therapy involves the delivery of complex treatments to patients. In recent years, there have been several promising clinical trial results within this field targeting an array of inherited neurodegenerative disorders, genetic diseases, and various cancers. Approvals based on these clinical trials have consequently encouraged interest in gene therapy from both industry
Researchers at Stanford University in the US have developed new sensors that can be adhered to the skin for wireless health monitoring. The sensors are designed to identify the physiological signals that the skin emanates, such as pulse. These readings will be wirelessly transmitted to a receiver clipped onto clothing. The sensor and receiver system
Overall, the growth in Asia’s bioprocessing capacity, particularly in China, has been impressive, albeit from a low baseline. Capacity growth over the past five years has been over 20 percent annually.1 New facility construction and expansions reflect the demand for biologics for domestic consumption, while other facilities are beginning to develop manufacturing strategies for GMP production
Treatments for baseball pitcher Max Scherzer and other pros may mislead fans about costly, controversial, unapproved stem cell shots. Source KHN Baseball superstar Max Scherzer — whose back injury has prevented him from pitching for the Washington Nationals since he last played on July 25 — is the latest in a long list of professional athletes to embrace unproven stem cell
The agency said Friday that it had approved Celgene’s Inrebic (fedratinib), the first new drug approved for the disease – a type of rare blood cancer – since the approval of Incyte’s Jakafi. The Food and Drug Administration has approved the first new drug for a type of rare blood cancer in nearly a decade.
