Dyve Bioscience this week touted data from a human proof-of-concept pilot study of its transdermal sodium bicarbonate therapy for pain reduction in people with acute gout flare. The study enrolled 24 people with a history of gout. Those in the active treatment group were given lotion containing sodium bicarbonate and menthol, while those in the […]
Novartis launches COPD inhalers in China
Novartis (NYSE:NVS) has launched its Ultibro Breezhaler and Seebri Breezhaler in China for the treatment of chronic obstructive pulmonary disease. The Ultibro Breezhaler system is a once-daily fixed-dose combination of indacaterol and glycopyrronium bromide. Seebri Breezhaler is a fixed-dose formulation of glycopyrronium bromide. The inhaled therapies are approved in more than 90 countries, including the U.S. […]
Novocure launches pivotal ovarian cancer trial
Novocure (NSDQ:NVCR) said today that it kicked off a Phase 3 pivotal trial testing its Tumor Treating Fields therapy combined with paclitaxel in people with recurrent, platinum-resistant ovarian cancer. The 540-patient trial has a primary endpoint of overall survival, with secondary endpoints that include progression-free survival, objective response rate, severity and frequency of adverse events and […]
Novo Nordisk seeks FDA nod for oral diabetes pill
Novo Nordisk (NYSE:NVO) said this week that it submitted applications to the FDA for its oral formulation of semaglutide, a once-daily glucagon-like peptide-1 receptor agonist therapy. The company is hoping its pill will be approved as an adjunct to diet and exercise to improve blood sugar control in adults with Type 2 diabetes. Novo Nordisk also […]
OptiScan raises $20m for bedside glucose monitoring system
OptiScan Biomedical said today that it closed a $20 million Series E round to support the commercialization of its continuous monitoring system, the OptiScanner 5000, in the U.S. The company’s device is an automated bedside blood glucose monitor designed for use in the intensive care unit. The system can measure glucose values from a micro-sample […]
Sage wins historic FDA nod for postpartum depression therapy
Sage Therapeutics (NSDQ:SAGE) this week won FDA approval for the first medicine indicated to treat postpartum depression. The Cambridge, Mass.-based company’s injection therapy, Zulresso, is slated to be available in late June. Postpartum depression is the most common medical complication of childbirth, according to Sage, and affects roughly one in nine women who have given birth […]
Theranos whistleblower Tyler Shultz to participate in keynote interview at DeviceTalks Boston
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. DeviceTalks is excited to announce that Tyler Shultz will be the closing keynote speaker at DeviceTalks Boston. Shultz will take attendees behind the story that everyone […]
Surmodics shares down following FDA’s paclitaxel device update
Surmodics (NSDQ:SRDX) shares fell last week after the FDA wrote a letter to doctors detailing a trend of heightened mortality in people with peripheral artery disease who were treated with paclitaxel-coated devices. In an SEC filing, the company said that it’s working with the FDA to clarify how the company should proceed with an ongoing clinical […]
EOFlow wins breakthrough status for wearable closed-loop insulin delivery tech
Korean medtech company EOFlow said last week that it won breakthrough status from the FDA for its closed-loop automated insulin delivery system for people with Type 1 diabetes. The EOPancreas system features a wearable patch, continuous glucose monitoring systems and a closed-loop blood glucose control algorithm. “EOFlow was founded to democratize wearable drug delivery solutions […]
Aptar Pharma touts FDA approval of nasal spray device
Aptar Pharma said this week that its Bidose nasal spray device won FDA approval for use with a breakthrough depression therapy. The Crystal Lake, Ill.-based company’s Bidose tech enables two-shot nasal drug delivery. Aptar touted its manufacturing facility in Congers, NY, which supports the manufacture of nasal and injectable drug delivery systems. “We are pleased […]
