Inovio Pharmaceuticals (NSDQ:INO) touted today positive safety and immune response data from the first-in-man Phase I trial of its vaccine against the Zika virus. The trial showed that Inovio’s DNA-based vaccine triggered high levels of binding antibodies in all 40 participants. The team also reported observing a strong neutralizing antibody and T-cell immune response in vaccinated […]
Drug-Device Combinations
OptiNose sets terms for $100m IPO
OptiNose set terms for its IPO this week, according to a regulatory filing submitted to the SEC. The company plans to offer 6.3 million shares at $15 – $17 apiece and funds affiliated with Avista Capital Partners intend to buy $25 million worth of shares as part of the offering, according to OptiNose. The company is slated to […]
Pavmed to drop 510(k), pursue de novo pathway for PortIO infusion system
Pavmed Inc. (NSDQ:PAVM) plans to drop the 510(k) application for its PortIO intraosseous infusion system and instead pursue a de novo pathway for its device, according to a document the company filed with the SEC yesterday. The move is based on a recommendation from the FDA, the company said. Get the full story at our sister site, Drug […]
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. Get the full story at […]
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. Get the full story at our sister site, Drug Delivery Business News.
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%, the […]
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 said in […]
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 designed to evaluate […]
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. Get the full story at our sister site, Drug Delivery Business News.
Novo Nordisk wins FDA nod for fast-acting mealtime insulin
Novo Nordisk (NYSE:NVO) said today that the FDA approved its Fiasp insulin aspart injection. The fast-acting mealtime insulin is designed to improve glycemic control for adults with Type I and Type II diabetes. The injection can be taken at the start of a meal or within 20 minutes after starting a meal, Novo Nordisk reported. Get […]
Why Bigfoot Biomedical’s CEO thinks the diabetes industry has a data problem
Bigfoot Biomedical‘s chief executive is excited about Abbott‘s (NYSE:ABT) latest regulatory win – and it’s not just because the two companies have an established partnership. Yesterday, the FDA approved Abbott’s FreeStyle Libre Flash continuous glucose monitoring system. It’s the first device of its kind, allowing patients to track their blood glucose levels without the use of routine finger […]