Under the agency’s new commissioner, Dr. Scott Gottlieb, the FDA has reportedly extended the time for comments in its review of off-label communication rules. In the past, Gottlieb has advocated for off-label uses of medical products, arguing that doctors are adequately trained to make decisions in the best interest of their patients. The FDA maintains […]
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Sirtex SIR-Spheres fail to improve survival in colorectal trial
Sirtex Medical (ASX:SRX) saw shares tumble more than 25% today after a trial of its radioactive microspheres reported no effect in improving survival in patients with colorectal cancer. Results from the Foxfire analysis study indicated that the use of SIR-Spheres Y-90 microspheres in combination with chemotherapy did not improve overall survival in patients with unresectable […]
Nemaura touts data for Memspatch insulin micro-needle device
Nemaura Pharma‘s Memspatch insulin micro-needle device compared well against a pen injector in an 18-patient clinical trials, according to the company. The group of Type I diabetic patients were given insulin using either the Memspatch device or a traditional pen injector. Researchers evaluated the patient’s pain levels using a number pain rating score from 0 […]
Navigating the regulatory and development pathways for drug-device products
David Lee began his path to CEO of Lumicell in 1999, when his wife was diagnosed with cancer. She passed away in 2003, while Lee was working in the semiconductor industry. He decided it was time for a career change. More than a decade later, Lee holds the corner office at a company that is […]
Dr. Reddy’s liposomal doxorubicin wins FDA nod
Dr. Reddy’s Laboratories (NYSE:RDY) said today that the FDA approved its doxorubicin hydrochloride liposome injection for intravenous administration. The liposomal formulation is a therapeutic-equivalent generic version of the chemotherapeutic, Doxil. “This approval represents the 1st of its kind for Dr. Reddy’s in the complex depot injectables arena,” Alok Sonig, executive VP and head of the U.S. […]
Alucent wins FDA nod for trial of novel drug-device PVD treatment
Alucent Medical said today that it won FDA approval to begin Phase I clinical studies of its Natural Vascular Scaffolding, a novel combination drug-device therapy for the treatment of peripheral vascular disease. Percutaneous balloon angioplasty, a process that involves drug-coated balloons and metal stents, is the traditional standard of care for peripheral vascular disease. These […]
Powering the next generation of ingestible drug delivery devices
Traditional implants in the gastrointestinal tract are meant to pass through a patient’s system, delivering a drug in short bursts or recording the health of a patient’s colon. But in recent years, scientists have sought after ultra-long lasting ingestible devices that can deliver drugs for several weeks in a patient’s GI tract. Lyndra, Inc., a start-up […]
Novelion CEO leaves Nordisk board due to potential conflict of interest | Personnel Moves – May 16, 2017
Novo Nordisk (NYSE:NVO) said this week that the CEO of Canadian biotech Novelion Therapeutics, Mary Szela, left Nordisk’s board effective immediately due to a “potential conflict of interest”. Szela’s departure follows Novelion’s decision to expand into non-alcoholic steatohepatitis, also known as fatty liver, according to a Nordisk spokeswoman. As the Danish drugmaker faces increasing pricing pressure […]
Study: Rivanna’s anesthesia placement device boosts accuracy, efficacy
Rivanna Medical touted data from 3 trials today showing that its Accuro automatic spinal navigation system boosts the accuracy of epidural and spinal anesthesia placement compared to traditional techniques, even for residents-in-training. Accuro is a pocket-sized ultrasound system that automatically detects spinal midline, epidural depth and trajectory. One trial at the University of Virginia Medical […]
Infertility: There could be a 3D printing solution
New Northwestern University research offers a potential 3D printing solution for women’s infertility – providing hope for cancer survivors who want to start families. The Northwestern researchers successfully 3D printed a bioprosthetic mouse ovary that ovulated when implanted inside a live mouse. Mice with the bioprosthetic ovaries were able to give birth to live pups, […]