CSA Medical said today that the first patient was treated using the company’s new rapid AV spray catheter for the management of persistent symptomatic esophageal cancer and associated dysplastic Barrett’s disease. The device uses a stainless steel catheter wall to cut the time needed to deliver liquid nitrogen spray to the treatment site by 50%, […]
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Report: Mylan to pony up $20m to Massachusetts in EpiPen settlement
Mylan (NSDQ:MYL) is slated to pay $20.3 million to the Massachusetts Medicaid program to resolve claims that it underpaid the program by misclassifying its EpiPen device, according to attorney general Maura Healey. “Mylan knowingly misrepresented this drug to MassHealth in order to underpay on rebates and make a profit at the expense of our state,” Healey […]
GE Healthcare, Blue Earth Diagnostics ink UK manufacturing deal
Blue Earth Diagnostics and GE Healthcare (NYSE:GE) said today that the group has inked a deal to establish the manufacturing of Blue Earth Diagnostic’s positron emission tomography imaging product, Axumin, in the U.K. The agreement with GE Healthcare is part of Blue Earth Diagnostics’ move towards commercializing Axumin since it won marketing authorization from the European […]
FDA commish: Rising drug prices are a public health concern
The FDA plans to tackle rising drug prices, according to the regulatory watchdog’s commissioner, Dr. Scott Gottlieb. Taking action to regulate the cost of prescription medicines would belargely unprecedented for the agency, which usually sticks to deciding whether a drug is safe and effective. But in a blog post this week, Gottlieb described high drug […]
PnuVax lands $29m grant for pneumonia vaccine
PnuVax said this week that it landed a $29.4 million grant from the Bill & Melinda Gates Foundation to develop and test its pneumococcal conjugate vaccine. The company is slated to receive milestone payments over the next three years as its vaccine moves through development and into proof-of-concept clinical trials. PnuVax’s product is designed to […]
Fifth patient treated in Flowonix, Cerebral Therapeutics epilepsy study
Flowonix Medical and Cerebral Therapeutics said today that the fifth patient was successfully treated in its Address trial, which features a micro-infusion device controlling drug delivery to a particular part of the brain in patients with medically refractory epilepsy. The study is the first of its kind, according to the companies. The Address trial is […]
DarioHealth launches smart diabetes tech in German market
DarioHealth (NSDQ:DRIO) said today that it launched its smart diabetes platform in Germany – the ninth country in which the Israel-based company’s technology is commercially available. DarioHealth’s platform includes a blood glucose monitoring system, which connects via a headphone jack to a mobile device. The system also includes a lancing device and test strips, together with […]
BioCorRx locks in Jan 2017 pre-IND FDA meeting for naltrexone implant
BioCorRx (OTC:BICX) said late last week it scheduled a pre-investigational new drug meeting with the FDA for its BICX102 naltrexone implant for next January as the company works on an IND application for the implant. The Anaheim, Calif.-based company said that its scheduled pre-IND meeting will not preclude it from submitting its IND application before that date. […]
Revive Therapeutics inks R&D deal with Sanyal for liver disease treatments
Revive Therapeutics (OTC:RVVTF) said today it inked a collaborative research deal with Sanyal Biotechnology looking to explore the use of cannabinoids as potential treatments for liver diseases. The collaborative deal will initially focus on the use of cannabidiol on a novel autoimmune hepatitis model, using the Diamond model which was designed and developed by Sanyal Biotechnologyspecifically […]
Seattle Genetics wins FDA Breakthrough Therapy Designation for Hodgkin lymphoma treatment
Seattle Genetics (NSDQ:SGEN) said today that the FDA granted Breakthrough Therapy Designation to its antibody-drug conjugate Adcetris in combination with chemotherapy for treating patients with advanced classical Hodgkin lymphoma. The approval was based on positive top line results from the company’s phase 3 Echelon-1 clinical trial, which were announced in June. The Bothell, Wash.-based company said […]