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 […]
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 […]
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 […]
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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