Flu vaccine rates in kids dropped slightly during last year’s influenza season, according to a study from the Penn State College of Medicine, and it may be partly due to a recommendation from the Centers for Disease Control and Prevention against the nasal spray vaccine, FluMist. When the nasal spray vaccine was first approved in […]
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Drug printing tech could enable pharmacies to make custom medications
Researchers at the University of Michigan have devised a way to print precise, pure doses of drugs onto a dissolvable strip, microneedle patch or dosing device, according to a study published in Nature Communications. The technology could one day allow pharmacies and hospitals to print custom-dosed medications for patients and boost drug development among researchers, the […]
FDA expands protocol for investigational ReCell burn injury device
Avita Medical (ASX:AVH) said today that the FDA approved a supplement to the company’s investigational device exemption for its ReCell autologous cell harvesting device. The approved treatment protocol for burn injuries has been simplified, according to the company, and the number of approved investigational sites has grown from eight to 15. Up until now, treatment using […]
Eli Lilly’s Humalog Junior KwikPen diabetes drug-device combo launches in U.S.
Eli Lilly‘s (NYSE:LLY) Humalog Junior KwikPen insulin lispro injection is available in the U.S. by prescription for people with diabetes, the company said today. The drug-device combination product is designed as a pre-filled, disposable half-unit insulin pen. The Humalog Junior KwikPen won FDA approval in June this year and earlier last month, a European Medicines […]
First patient treated with CSA Medical’s AV spray catheter
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%, […]
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 […]