Valeritas (NSDQ:VLRX) said today that its wearable insulin delivery device has launched in Italy. The Bridgewater, N.J.-based company inked an exclusive distribution deal with Movi SpA to bring its V-Go device to the more than 2 million people in Italy with Type 2 diabetes. “We are happy to announce the V-Go Wearable Insulin Delivery device is […]
FDA deals warning letter to Ocular over eye sealant
Ocular Therapeutix (NSDQ:OCUL) said today that it received a warning letter from the FDA over its ReSure hydrogel ocular wound sealant. The warning letter, dated Oct. 17, relates to Ocular’s compliance with data collection and reporting obligations in a post-approval device exposure registry study, according to the company. The registry study was a condition for approval […]
Dexcom wins CMS nod for latest glucose monitor
Dexcom (NSDQ:DXCM) said today that its G6 continuous glucose monitoring system will be covered for Medicare beneficiaries. The company’s product won coverage as a therapeutic CGM system, making it available to beneficiaries who closely manage their insulin dosing. “The Dexcom G6 is a game-changer for people with diabetes, and we are thrilled to provide this innovative […]
Abbott CEO on Libre: ‘We’re just getting started’
Abbott (NYSE:ABT) posted its third quarter financial results yesterday, meeting its own forecast and the consensus set by analysts on Wall Street. The healthcare giant also narrowed its earnings outlook for the rest of the year. Abbott noted particularly high gains in revenue for its medical device division – sales were up 8.4% to $2.82 billion, in […]
Anthem, Novo Nordisk team up for real-world diabetes drug study
Anthem’s outcomes research unit, HealthCore, and Novo Nordisk (NYSE:NVO) have joined forces to study Novo Nordisk’s semaglutide GLP-1 receptor agonist in people with Type 2 diabetes. The real-world trial is designed to compare the long-term effectiveness of the drug, also known as Ozempic, against 40 other medications among 2,250 adults with Type 2 diabetes. “Because the Sepra […]
Nanobiotix reels in $18.5m tranche from European Investment Bank
Nanobiotix (PAR:NANO.PA) received €16 million ($18.5 million) in the first tranche of a previously-announced non-dilutive loan from the European Investment Bank. The five-year funding deal is designed to support the company’s development of nanoparticle-based cancer therapies. Nanobiotix is specifically charged with bringing its NBTXR3 product through a clinical development program in patients with head and neck […]
Valeritas aims for $50m in stock offering
Valeritas (NSDQ:VLRX) said this week that it plans to offer 37,593,984 shares of its common stock, hoping to raise $50 million in gross proceeds. The medical technology company also announced its preliminary financial results this week for the third quarter of 2018. The Bridgewater, N.J.-based company expects to post quarterly revenue of approximately $6.9 million, just […]
FDA approves five-year hormonal contraceptive
Allergan (NYSE:AGN) and the nonprofit women’s health pharma company Medicines360 said today that the FDA approved an application to extend the duration of use for Liletta for the prevention of pregnancy for up to five years. Medicines360 first won approval for the levonorgestrel-releasing intrauterine device in February of 2015. The system’s latest FDA approval is based on a […]
Medtronic launches workflow system to help wean patients off oral opioids
Medtronic (NYSE:MDT) said today that it launched its Control Workflow system in the U.S. for use with its SynchroMed II intrathecal drug-delivery system. The medtech titan is hoping that, combined with its pain pump, the workflow system can help physicians in weaning patients off oral opioids. In a retrospective claims analysis, Medtronic found that 51% of […]
Kala seeks FDA nod for dry eye disease drug
Kala Pharmaceuticals (NSDQ:KALA) said today that it submitted a new drug application to the FDA for its KPI-121 0.25% topical product designed for patients with dry eye disease. The Waltham, Mass.-based company noted that roughly 33 million people in the U.S. have dry eye disease and nearly 90% of those patients experience flares in symptoms. Kala […]
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