RDD Pharma's RDD-0315, being developed to treat fecal incontinence in spinal cord injury patients, has been granted fast-track designation by the FDA.
Members of India's health care industry say a unified regulatory body for medical devices and pharmaceuticals would remove the complexities hampering the sector's progress. Industry representatives say the government's current system makes getting approvals time-consuming, while its pricing control on equipment is discouraging innovation.
Medtronic says results of a safety analysis of its In.Pact Admiral paclitaxel-coated balloon will not be changed by a programming error that caused an unspecified number of deaths to be omitted from the data. The studies are being revised, but the company says this data will not affect the long-term safety rates of the device, and the revised data show no statistically significant difference in patient deaths between the product and plain balloon angioplasty at five years in patients with peripheral artery disease.
The European Medicines Agency has suspended fenspiride medicines in Europe because of the potential to increase QT intervals, which can lead to ventricular arrhythmia. The drug is intended to relieve cough caused by lung diseases.
Duke University investigators seeking to develop a possible cure for Duchenne muscular dystrophy, in collaboration with Sarepta Therapeutics, announced promising data from a trial using CRISPR-Cas9 technology to treat DMD in mouse models, which indicated that a single treatment was able to correct the disease for over a year. Findings were reported in the journal Nature Medicine.
Researchers reported in the journal Nature Biotechnology that they used CRISPR gene editing to switch off two genes and overexpress the CD47 gene to develop pluripotent stem cells that did not trigger an immune response after transplantation in tests involving animals. "This is the first time anyone has engineered cells that can be universally transplanted and can survive in immunocompetent recipients without eliciting an immune response," said lead author Tobias Deuse of the University of California at San Francisco.
A late-stage trial evaluating Merck's Keytruda, or pembrolizumab, in combination with Pfizer's Inlyta, or axitinib, showed superiority to Pfizer's Sutent, or sunitinib, as a first-line treatment in patients with renal cell carcinoma. The combination achieved an overall response rate of 59.3% versus 35.7% for Sutent.
AKL Research & Development's early-stage osteoarthritis drug, APPA, has been awarded about $877,000 from Innovate UK.
Professor Appolinaire Djikeng in Edinburgh, Scotland, is developing biotech cows, chickens and pigs with traits that are beneficial to subsistence farmers, including disease resistance, heat resistance and increased production. Having grown up on a smallholder farm, Djikeng speaks from personal experience when he says, "If the animals die or are not producing to their potential, it means no income for the smallholder's family and the risk of falling into absolute poverty."
Eni and RenOils agreed to collaborate to promote reusing of vegetable oils for biofuel production.
- Page 1