Flexion Therapeutics (NSDQ:FLXN) touted data today from a Phase II trial assessing the bilateral dosing of its extended-release triamcinolone acetonide injection in people with bilateral osteoarthritis. The study found that bilateral injections of Flexion’s Zilretta therapy resulted in lower plasma concentrations of triamcinolone acetonide compared to immediate-release triamcinolone acetonide in crystalline suspension (TAcs). The company also […]
Clinical Trials
Novocure touts Phase II pancreatic cancer pilot study
Novocure (NSDQ:NVCR) today touted the results of a Phase II pilot trial designed to test the feasibility, safety and efficacy of its Tumor Treating Fields therapy in patients with unresectable, advanced pancreatic cancer. The St. Helier, N.J.-based company’s Optune device uses electric fields, called Tumor Treating Fields, to disrupt cell division, inhibit tumor growth and trigger […]
NxStage touts home hemodialysis study data
NxStage Medical (NSDQ:NXTM) today released data from a study comparing home hemodialysis to traditional treatment in a skilled nursing facility, touting a lower risk of death and cardiovascular hospitalization for those treated more often with home hemodialysis. Full results from the trial are slated to be presented at the American Society of Nephrology Kidney Week 2018 […]
U Penn trial regrows dental pulp from baby tooth stem cells
Data from recent clinical trial out of the University of Pennsylvania suggest that the use of stem cells from a patient’s baby teeth could be used to help regrow dental pulp tissue. Results from the trial, which was conducted in China, were published in the journal Science Translational Medicine. In the trial, 40 children were […]
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. Get the full story […]
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 […]
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 […]
Zimmer Biomet launches clinical trial with Apple Watch
Zimmer Biomet (NYSE:ZBH) said today that it’s launching a clinical trial using the Apple Watch to help hip and knee replacement patients that could enroll as many as 10,000 patients. Using the orthopedic giant’s MyMobility app and the Apple Watch, the study aims to evaluate the app’s utility in improving outcomes and lowering costs, Warsaw, Ind.-based Zimmer […]
NeoTract says real-world prostate study beats clinical trial results
A study evaluating NeoTract’s UroLift treatment for men with enlarged prostate glands showed a 62% improvement in lower urinary tract symptoms, the company said today. The real-world study enrolled 100 men with benign prostatic hyperplasia (BPH) at a single center. Peak flow rate improved 140% and the post-void residual volume (PVR) decreased by 71 ml, with […]
FDA: TearLab’s Discovery MMP-9 test 510(k) fails to meet substantial equivalence
TearLab Corp. (OTC:TEAR) said this week that the FDA ruled that the company’s 510(k) submission for its TearLab Discovery MMP-9 test, designed to measure an inflammatory biomarker found in tears, did not meet criteria for substantial equivalence. The San Diego-based company’s TearLab Discovery lab-on-a-chip platform is intended to analyze multiple biomarkers in human tears with nanoliter […]
Boston Scientific touts 3-year Solyx stress urinary incontinence mesh trial data
Boston Scientific (NYSE:BSX) this week released three-year data from a study of its Solyx single incision sling system intended to treat stress urinary incontinence, touting that the trial met all primary and secondary endpoints. Boston Scientific said it presented the full results from the trial yesterday at the annual scientific symposium of the American Urogynecologic Society. The […]