Tandem Diabetes Care (NSDQ:TNDM) said today that it plans to use its remote software update tool to address an anomaly found in an ongoing pivotal trial of its Control-IQ technology. The anomaly, according to Tandem, relates to how the company’s t:slim X2 insulin pump with Control-IQ technology handles continuous glucose monitoring data under undisclosed conditions. The […]
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FDA approves J&J’s nasal spray for treatment-resistant depression
The FDA has approved Johnson & Johnson‘s (NYSE:JNJ) esketamine nasal spray for people living with treatment-resistant depression. The company’s product, Spravato, is an intranasal formulation of ketamine – a horse tranquilizer that is also known as Special K. The drug won support for approval from an FDA advisory committee earlier this year. Spravato is the […]
Valeritas posts mixed Q4 results
Valeritas (NSDQ:VLRX) posted its fourth-quarter and full-year financial results today, missing earnings estimates but topping revenue expectations on Wall Street. The Bridgewater, N.J.-based company posted a net loss of -$11.9 million on sales of $6.89 million for the three months ended Dec. 31, for sales growth of 19% compared with the same period last year. Earnings […]
Pacira to acquire Myoscience in $220m deal
Pacira Pharmaceuticals (NSDQ:PCRX) said today that it has signed a deal to acquire Myoscience and its pain relief device for up to $220 million. Myoscience’s iovera system is designed to safely freeze nerves while protecting surrounding tissue. As part of the deal that is slated to close by early April, Pacira plans to incorporate the iovera […]
Nemera’s multidose eye dropper Novelia approved for Santen’s Cosopt in 29 European countries
(Press Release) – Santen announced that the preservative-free formulation Cosopt iMulti will launch in 29 European countries in the coming months. Nemera is pleased to announce that its multidose eye dropper Novelia has been approved for the preservative-free formulation Cosopt iMulti (20mg/ml dorzolamide + 5mg/ml timolol eye drops, solution). The granting of licenses by the […]
Senseonics inks CGM data deal with Glooko
Senseonics (NYSE:SENS) said today that data from its Eversense continuous glucose monitoring system can be integrated into Glooko‘s diabetes data management tech. Thanks to the new partnership, Eversense users will be able to view historical glucose trends in Glooko’s mobile and web apps as well as real-time data from the Eversense mobile app, according to Senseonics. […]
Teva launches generic for Pfizer’s Flector pain patch
Teva (NYSE:TEVA) said last week that it launched a generic version of Pfizer‘s (NYSE:PFE) Flector diclofenac epolamine patch. Using a nonsteroidal anti-inflammatory drug, the topical patch is designed to treat acute pain due to minor strains, sprains and contusions. Pfizer’s Flector patch garnered annual sales of $123 million in the U.S. as of Dec. 2018, according […]
Medtronic updates on corrected safety analysis for paclitaxel-coated balloon
Medtronic (NYSE:MDT) said last week that a revised safety analysis of its In.Pact drug-coated balloon has been accepted by the Journal of the American College of Cardiology. Last month, the medtech titan reported that a programming error inadvertently caused mortality data to be omitted from a statistical analysis involving the company’s paclitaxel-coated balloon. The announcement came […]
Rani debuts human trial data for robotic pill tech
Rani Therapeutics this week touted the results of a first-in-human feasibility trial for its swallowable robotic pill, the RaniPill. Rani has developed a capsule that delivers an intestinal injection of medicine without exposing the drugs to digestive enzymes. The RaniPill device travels through the stomach and eventually reaches the intestine, where it injects the drug […]
Novocure shares dip on Q4, 2018 earnings miss
Shares in Novocure (NSDQ:NVCR) fell slightly today after the medical device maker missed expectations on Wall Street with its fourth quarter and full year 2018 earnings release. The St. Helier, Jersey-based company posted losses of $15.6 million, or 17¢ per share, on sales of $69.7 million for the three months ended December 31, seeing losses grow […]