Boehringer Ingelheim on Tuesday touted results from the Phase III CanoTinA asthma trial, which showed that adding tiotropium Respimat to maintenance asthma therapy in kids ages 6-11 significantly improves lung function compared to placebo. The results were presented Tuesday at the European Respiratory Society International Congress 2016 in London. This comes 1 day after results from another clinical trial […]
Clinical Trials
JDRF backs Sernova’s implant for T1D
Canadian-based drug device maker Sernova Inc. is working with the Juvenile Diabetes Research Foundation on a clinical trial of Sernova’s cell pouch system to treat hypoglycemia unawareness patients with severe type 1 diabetes. The JDRF will give $2.45 million to support a clinical trial at a transplantation center in the U.S., according to the agreement. Hypoglycemia […]
GlaxoSmithKline’s triple combo with Innoviva tops Symbicort Turbohaler in COPD
GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) yesterday touted results from a Phase III study investigating the triple-combination therapy fluticasone furoate/umeclidnium/vilanterol for patients with chronic obstructive pulmonary disease. The 1,810-patient Fulfil study is a randomized, double-blinded trial comparing once-daily FF/UMEC/VI against AstraZeneca‘s (NYSE:AZN) Symbicort Turbohaler dry powder inhaler, a twice-daily combination of budesonide and formoterol. Patients in the FF/UMEC/VI […]
Boehringer Ingelheim touts Stiolto Respimat data
Boehringer Ingelheim yesterday touted results from a Phase III trial showing that its Stiolto Respimat, a drug-device combination helps people with chronic obstructive pulmonary disease walk for longer periods of time while relieving some shortness of breath. When participants with moderate to severe COPD took Stiolto Respimat, a combination of tiotropium bromide and olodaterol, along […]
Novocure touts data from Optune-paclitaxel combination study
By Sarah Faulkner NovoCure (NSDQ:NVCR) announced yesterday that its ‘tumor treating fields, combined with the drug paclitaxel, are effective against ovarian cancer, the 5th most-common cause of cancer death in women in the US. The St. Helier, N.J.-based company won FDA approval in July for the Optune device to treat a type of brain cancer called glioblastoma. TTFields […]
Taris launches another Phase I trial for bladder cancer drug-device combo
Taris Biomedical said today it is launching a new phase I trial of its TAR-200 gemcitabine releasing intravesical system designed to deliver drugs directly to the bladder for patients with non-muscle-invasive bladder cancer. The phase 1b open-label study is slated to enroll 30 patients to explore whether continuous, local exposure to gemcitabine using TAR-200 is […]
Struggling GlaxoSmithKline bets big on neural implants to fuel turnaround
GlaxoSmithKline‘s (NYSE:GSK) interest in tiny neural implants is stronger than ever, even amid declining earnings and flopped drug candidates that have turned CEO Andrew Witty into a lame duck who will step aside in 2017. Despite the turmoil, the British pharma giant is investing $50 million in so-called bioelectronics via Action Potential Ventures, aiming to fund companies […]
Ocular Therapeutix shares plummet as 2nd Phase III misses primary endpoint
Ocular Therapeutix (NSDQ:OCUL) today saw shares dive over 40% after reporting the 2nd phase 3 clinical trial of its Dextenza drug-device combination failed to meet its primary endpoint. Bedford, Mass.-based Ocular Therapeutix’s Dextenza, formerly known as OTX-DP, is designed to deliver sustained dosage of dexamethasone over 4 weeks using a hydrogel plug inserted into a tear […]
Otsuka gets in on ReCor Medical's Paradise renal denervation device
ReCor Medical said it landed a strategic investment from Japanese conglomerate Otsuka Pharmaceutical (TYO:4578) that will bring to Asia its Paradise renal denervation device for treating hypertension. Neither side is disclosing financial terms, but the deal calls for Otsuka to receive exclusive rights to pursue clinical trials, regulatory approval and commercialization of ReCor’s Paradise device in Japan, China, Korea […]
SurModics launches 1st-in-human trial for SurVeil drug-coated balloon
SurModics (NSDQ:SRDX) said it enrolled the 1st patient in an early feasibility trial of its SurVeil drug-coated balloon for treating peripheral artery disease, as it looks to metamorphose from device coating provider to medical device maker. The FDA granted investigational device exemption for the trial late last year, the Eden Prairie, Minn.-based company said. The […]
