Senseonics (NYSE:SENS) said yesterday that its Eversense XL 180-day continuous glucose sensor was implanted into the first participant of a trial designed to support a pre-market application to the FDA. The company’s 180-patient Promise trial is slated to study the safety and efficacy of the Eversense device in people with diabetes over 180 days. Senseonics also […]
Wall Street Beat
Medtronic, IBM Watson debut hypoglycemia prediction feature for diabetes app
Medtronic (NYSE:MDT) and IBM Watson Health today launched a new feature for its Sugar.IQ personal diabetes assistant app that can predict the likelihood of a user experiencing a low glucose event within a four-hour window. The feature, called IQcast, uses AI tech from IBM and becomes more accurate as the low blood sugar event draws nearer, […]
Valeritas’ V-Go wins preferred status on Humana’s Medicare formularies
Valeritas (NSDQ:VLRX) said today that its V-Go insulin delivery device won preferred status on Humana’s Part D formularies. The Bridgewater, N.J.-based company’s device is designed for people with Type 2 diabetes. Worn like a patch, the V-Go product delivers a continuous preset basal rate of insulin over 24 hours and can also provide on-demand bolus dosing […]
DarioHealth inks U.S. distro deal for digital diabetes management program
DarioHealth (NSDQ:DRIO) said today that it inked a deal with healthcare products provider Better Living Now for the distribution of its blood glucose monitoring system and the DarioEngage digital health program. According to the terms of the deal, BLN plans to buy DarioHealth’s smart glucose meter and test strips to distribute to its customers. The agreement […]
Report: Pharma companies kick off new year with price hikes
Major pharmaceutical firms started the new year by hiking the prices of hundreds of drugs, according to a new study published by Rx Savings Solutions. First reported in The Wall Street Journal, the study found that the average price increase taken by more than three dozen companies was roughly 6.3%. Allergan (NYSE:AGN) topped the list, raising the […]
Heron Therapeutics wins priority review for postoperative pain drug
Shares in Heron Therapeutics (NSDQ:HRTX) rose today after the biotech reported that the FDA gave priority review status to its investigational postoperative pain drug. The company’s HTX-011 product is a long-acting formulation of bupivacaine in combination with the anti-inflammatory meloxicam. Heron touts the product as the first dual-action, fixed-combination drug designed to address postoperative pain […]
PolarityTE registers bone repair product with FDA
PolarityTE (NSDQ:PTE) said last week that it registered its bone repair product, OsteoTE, with the FDA. The Utah-based company’s technology is an autologous, homologous product designed to repair, reconstruct and replace bone using a patient’s own cells. In preclinical trials, OsteoTE regenerated bone with similar characteristics to natural bone, according to PolarityTE. The company also […]
Ocular Therapeutix lands $25m term loan
Ocular Therapeutix (NSDQ:OCUL) said today that it closed a refinancing of its existing debt by landing a $25 million term loan with MidCap Financial and Silicon Valley Bank. The 5-year term loan facility expanded the company’s prior $18 million credit facility to $25 million. The proceeds from the loan were used to repay the $12.3 million […]
FDA to review Kala’s dry eye disease drug
Kala Pharmaceuticals (NSDQ:KALA) said today that the FDA accepted the new drug application for Kala’s dry eye disease therapy, KPI-121 0.25%. The two-week treatment features Kala’s mucus-penetrating particle drug-delivery technology and is designed for the temporary relief of sings and symptoms of dry eye disease. The FDA is slated to make a decision about KPI-121 0.25% […]
Acorda wins FDA nod for inhaled Parkinson’s therapy
Acorda Therapeutics (NSDQ:ACOR) said this week that the FDA approved its Inbrija device for the intermittent treatment of “off” episodes in people with Parkinson’s disease. The self-administered, inhaled therapy is designed for people experiencing a re-emergence of Parkinson’s symptoms. These “off” episodes are caused by low levels of dopamine between doses of the standard oral Parkinson’s […]
