The FDA has proposed that the International Council on Harmonisation set global standards for generic drug developers, according to a report from FDA chief Dr. Scott Gottlieb. The U.S. regulatory agency argued that companies making generic drugs should be able to implement a single global drug development program and file for approval across multiple markets […]
Valeritas launches wearable insulin delivery device in Italy
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 […]
Novaliq touts topline data for dry eye disease drug
Novaliq today touted topline data from the first pivotal trial of its CyclASol 0.1% drug designed to treat dry eye disease. The company is hoping to position its 0.1% cyclosporine A product as advantageous compared to other ophthalmic treatments, noting that its EyeSol technology helps boost the drug’s efficacy and provide an earlier onset of […]
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 […]
Phillips-Medisize inks deal to develop connected health platform for drugs
Phillips-Medisize said this week that it teamed up with healthcare software tech company InterSystems to develop a data-sharing and analytics platform designed for connected drug-delivery devices and mobile medical apps. The third-generation of Phillips-Medisize’s connected health platform, combined with InterSystems’ HealthShare platform, will allow pharma companies to connect medication and diagnostic data across their drugs […]
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 […]
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