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 […]
Teva to cut 500 jobs after closing Hungary facility
Teva Pharmaceutical (NYSE:TEVA) is reportedly closing its sterile injectables plant in Godollo, Hungray and 500 workers could lose their jobs. The generics-maker is slated to close or sell the facility by the end of 2018. The plant stopped production last year after the FDA found an array of sterility issues that the agency said put […]
The key components of a well-designed wearable: Sense, analyze, act
One of the earliest uses of a wearable technology was recorded during Emperor Nero’s rule over the Roman Empire from 54 to 68 AD. A brutal leader, the emperor enjoyed watching his gladiators fight in crowded stadiums. As Nero watched his fighters battle, he was confronted with a problem – the glaring sun made it difficult […]
New FDA commish extends time for comments on off-label communication rules
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 […]
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 […]