Minneapolis-based Urotronic said this week that the FDA approved an investigational device exemption trial for its Optilume drug-coated balloon catheter, which is designed to treat urethral strictures in men. The 200-patient pivotal trial is slated to start enrolling participants immediately. “Physicians are looking for a technology that is minimally invasive and also curative,” principal investigator […]
Curetis launches diagnostic cartridge for urinary tract infection
Curetis said today that it won CE-IVD marking for its Unyvero cartridge designed to diagnose severe urinary tract infections. The cartridge covers 103 diagnostic targets and can detect 88 pathogens, according to Curetis, including a multi-drug-resistant pathogenic fungus that is of particular concern to hospitalized patients with compromised immune systems. Unyvero UTI can also detect […]
Valeritas taps Glooko’s data management platform for next-gen insulin delivery device
According to a newly-inked deal between the two companies, Glooko plans to provide its diabetes data management platform to Valeritas (NSDQ:VLRX) for use with the medtech company’s next-gen V-Go insulin delivery device. Valeritas’ V-GO SIM device is an investigational accessory that the company said will snap onto its existing insulin delivery devices. The product is designed […]
Senators urge HHS to seek lower price for naloxone
U.S. Sens. Debbie Stabenow (D-MI) and Gary Peters (D-MI) penned a letter to the Dept. of Health and Human Services, urging the agency to demand that manufacturers lower the price of the opioid overdose reversal drug, naloxone. The lawmakers wrote that the price of naloxone has climbed dramatically since it was first approved by the […]
Report: Amazon abandons drug distribution and supply plans
Amazon‘s (NSDQ:AMZN) Business division has dropped plans to sell and distribute pharmaceutical products to hospitals, according to a new report from CNBC. The shift comes due to the online mega-retailer being unable to convince large hospital groups to change their purchasing process and break existing deals and relationships with distributors, according to the report. The […]
Glooko names digital health veteran as CEO | Personnel Moves – April 17, 2018
Glooko named health tech veteran Russ Johannesson as its new chief executive this month, adding that the diabetes data management company’s former CEO, Rick Altinger, is slated to become EVP of corporate development. Johannesson previously served as the chief operating officer of Sharecare, a digital health and wellness platform. Before that he led sales, marketing […]
AstraZeneca inks outcomes-based contract with Highmark for COPD, asthma drug
Health insurer Highmark inked an outcomes-based contract with AstraZeneca (NYSE:AZN) for Symbicort, the pharmaceutical company’s drug designed to treat asthma and chronic obstructive pulmonary disease. Highmark said its contract with AstraZeneca is one of the first outcomes-based deals involving a respiratory drug and will apply to commercial members of its national and core markets in Pennsylvania, […]
Novocure touts top-line data from Ph2 mesothelioma trial
Novocure (NSDQ:NVCR) today touted positive top-line data from its Phase II pilot mesothelioma trial and revealed that it plans to submit a humanitarian device exemption application to the FDA for approval. The St. Helier, N.J.-based company reported that patients who received treatment with its “Tumor Treating Fields” system plus chemotherapy experienced clinically meaningful improvements in overall […]
Johnson & Johnson’s global pharma sales up 19% in Q1
Johnson & Johnson (NYSE:JNJ) today reported first-quarter sales and earnings results, topping analysts’ expectations on Wall Street. The company’s pharmaceutical business delivered “robust growth,” chairman & CEO Alex Gorsky said in a statement; worldwide global sales grew 19.4% to $9.8 billion for the first quarter compared to same period in 2017. Domestic sales were up […]
In reversal, FDA accepts Alkermes’ depression drug for review
In an about-face, the FDA reportedly agreed to review a new drug application for Alkermes‘ (NSDQ:ALKS) depression drug just weeks after the agency said it would only do so if the company conducted additional trials. Alkermes’ once-daily oral medication is a fixed dose combination of buprenorphine and samidorphan, designed for patients with major depressive disorder […]
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