When Steven Schmidt worked at Vertex Pharmaceuticals (NSDQ:VRTX), Eric Olson – the man who led the development of the 1st drug to treat the underlying causes of cystic fibrosis – asked Schmidt to look into ways that families could become more engaged with managing a patient’s condition. Olson pointed towards a publication that showed that […]
Drug-Device Combinations
BTG touts Ekos data from pulmonary embolism trial
BTG (LON:BTG) touted data today from the Optalyse PE trial showing that pulmonary embolism can be treated effectively with Ekos over a shorter period and with smaller doses of thrombolytic drugs compared to the current standard. The 101-patient trial randomized participants to receive therapeutic anticoagulation and Ekos acoustic pulse thrombolysis therapy at different doses for different lengths […]
BoneSupport launches trial of antibiotic-eluting bone graft
BoneSupport said today that the 1st patient has been enrolled in the pivotal investigational device exemption trial for its injectable antibiotic-eluting bone graft substitute. The company’s Fortify trial plans to evaluate Cerament G’s ability to improve the traditional management of patients with open factures of the tibial diaphysis. The trial is slated to enroll up […]
Sanofi’s insulin biosimilar wins EMA committee recommendation
Sanofi (NYSE:SNY) said today that the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended its insulin lispro biosimilar for approval. Insulin lispro Sanofi is a biosimilar of insulin lispro, a fast-acting insulin analog made using recombinant DNA technology. Sanofi’s biosimilar has the exact same amino acid sequence as its reference product. The positive opinion […]
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 […]
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 […]
