Orchestra BioMed said today that it received breakthrough device designation from the FDA for its Virtue sirolimus-eluting balloon for the treatment of below-the-knee peripheral artery disease. The Virtue SEB is the first and only non-coated below-the-knee sirolimus-eluting angioplasty balloon system to receive a breakthrough nod, Orchestra BioMed said in a release. The New Hope, Pa.-based […]
Eitan Group inks Canadian distribution deal for Sapphire infusion pumps
Eitan Group today announced it signed a distribution agreement with Canadian Hospital Specialities to distribute its Sapphire infusion pumps in Canada. Through the agreement, Canadian Hospital Specialties will supply and support Israel-based Eitan Group’s Sapphire infusion pumps to hospitals and alternate site customers in Canada. “CHS works to introduce the most advanced medical technology to […]
Judge adds $10m in damages in Vectura-GSK patent spat
This article has been updated with a statement from Glaxo Smith Kline. A federal judge in Delaware has awarded British inhaler company Vectura an additional $10.5 million in compensatory damages from Glaxo Smith Kline (NYSE:GSK) in a patent dispute. In May, a jury awarded Vectura $89.7 million in damages for the period from August 2016 […]
How the Eitan Group aims to disrupt the infusion pump industry
Privately held Eitan Group wants to bring more infusion pumps into people’s homes. Can it compete against the established players? Officials at the Eitan Group want to disrupt the infusion pump market by selling devices that are more connected and software-based — able to be used not only in hospitals but in the home. Eitan is […]
Halozyme-Genentech breast cancer pivotal meets endpoint
Halozyme Therapeutics today announced positive endpoint results from its phase III intravenous chemotherapy trial. Genentech’s FeDeriCa study used Halozyme’s Enhanze drug-delivery technology for subcutaneous administration of a fixed-dose combination of pertuzumab (Perjeta) and trastuzumab (Herceptin), in combination with intravenous chemotherapy. The results showed non-inferior levels of Perjeta in the blood compared to standard IV infusion […]
FDA approves ready-to-use liquid glucagon from Xeris
Xeris Pharmaceuticals (NSDQ:XERS) said yesterday that the FDA has approved its Gvoke glucagon injection for the treatment of hypoglycemia. Gvoke is a ready-to-use, room-temperature, stable liquid glucagon designed to treat severe hypoglycemia in pediatric and adult patients with Type 1 diabetes aged two years old or above. Chicago-based Xeris’ Gvoke may be administered with a pre-filled […]
Cook Medical touts paclitaxel-coated stent PAD study results
Cook Medical today touted five-year data from a study into the use of its Zilver PTX paclitaxel-coated stent for peripheral arterial disease (PAD). The study concluded that there was no increase in long-term all-cause mortality due to paclitaxel after treatment using the Zilver PTX stent compared to traditional angioplasty or a bare-metal stent, according to a […]
Phillips Medisize buys mini-tablet dispenser from Global Pharmaceutical Company
Phillips-Medisize today said that it acquired exclusive ownership of patents supporting a mini-tablet dispenser from Global Pharmaceutical Company. The mini-tablet dispenser is mounted on top of a standard tablet bottle where a patient or caregiver can count and dispense mini-tablets in predetermined amounts from one to 20 tablets. It supports tablets sized 2×2 mm to […]
Satsuma Pharmaceuticals registers $75m IPO
Satsuma Pharmaceuticals has registered an initial public offering, seeking to raise $75 million, according to a regulatory filing. The South San Francisco-based company is working on STS101, a nasal powder version of dihydroergotamine for migraine. It intends to use the money to fund its Phase 3 safety and efficacy clinical trials for STS101, manufacturing costs, […]
Medtronic’s In.Pact AV DCB meets endpoints in trial
Medtronic (NYSE:MDT) said last week that its clinical study comparing the In.Pact AV drug-coated balloon to percutaneous transluminal angioplasty (PTA) met primary safety and effectiveness endpoints. The study pitted the In.Pact AV DCB against PTA in patients with de novo or non-stented restenotic arteriovenous fistulae lesions. Results were presented at the Cardiovascular and Interventional Radiology Society […]
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