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 […]
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. Get the full story at […]
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. Get […]
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. Get the full story at our sister site, Drug Delivery Business News.
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. Get the full story at our […]
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. Get the full story at our sister site, Drug Delivery Business News.
Oyster Point Pharma said yesterday that it raised $93 million in a Series B round to support the clinical development of its intranasal dry eye disease therapies. The Princeton, N.J.-based company’s lead product candidates for dry eye disease are designed to stimulate the trigeminal parasympathetic pathway to trigger natural tear film production. The drugs, OC-01 and OC-02, […]
Shares in Mylan (NSDQ:MYL) fell yesterday after the company missed earnings expectations but beat sales estimates on Wall Street with its fourth-quarter financial results. The Pittsburgh, PA-based company posted profits of $51.2 million, or 10¢ per share, on sales of $3.04 billion for the three months ended Dec. 31, for bottom-line loss of -79% on sales loss […]
Tandem Diabetes Care (NSDQ:TNDM) beat estimates on Wall Street today with its fourth-quarter and full-year financial results. The company also announced today that its CEO, Kim Blickenstaff, plans to assume the role of executive chairman and that COO John Sheridan will become president and CEO on March 1. Get the full story at our sister site, Drug Delivery […]
Insulet (NSDQ:PODD) posted its fourth-quarter and full-year financial results yesterday after the markets closed, beating estimates on Wall Street. The Acton, Mass.-based company posted profits of $9.9 million, or 17¢ per share, on sales of $164.9 million for the three months ended Dec. 31. It was the first time in the company’s history that it recorded […]
Glooko announced this month that it’s teaming up to connect Novo Nordisk‘s (NYSE:NVO) insulin pens with the company’s diasend diabetes management solution. Novo Nordisk plans to launch its connected insulin pens, the NovoPen 6 and NovoPen Echo Plus, in early 2019. Any provider using diasend and any person using the diasend mobile app will be able to sync […]