Elixir Medical‘s novolimus-eluting stent, DeSyne, outperformed Medtronic‘s (NYSE:MDT) zotarolimus-eluting stent, Endeavor, according to long-term data from Elixir’s Excella II trial. The study enrolled 210 patients with 2 or more de novo lesions in 2 different epicardial vessels. Researchers randomly assigned patients in a 2:1 ratio to the novolimus-eluting stent or the zotarolimus-eluting stent. The device emits a low […]
Clinical Trials
OncoSec wins fast track designation for electroporation combo therapy
OncoSec Medical (NSDQ:ONCS) said today that it won Fast Track Designation from the FDA for its ImmunoPulse IL-12 electroporation gene therapy for the treatment of metastatic melanoma. The biotech company’s electroporation device is designed to locally deliver DNA-based interleukin-12 to stimulate the immune system and fight off cancer cells. The ImmunoPulse device delivers a sequence […]
Intersect ENT wins FDA nod for Propel Contour steroid-releasing implant
Intersect ENT (NSDQ:XENT) said today that it won FDA approval for its Propel Contour steroid-releasing implant for the treatment of chronic sinusitis in the frontal and maxillary sinsuses. The Menlo Park, Calif.-based company’s portfolio of steroid-releasing implants are used in patients undergoing ethmoid, frontal or maxillary surgeries to treat chronic sinusitis. “The approval of Propel […]
Children’s National Health System highlights novel approach for cell therapy
Children’s National Health System touted data today from a Phase I dose-ranging study evaluating a cell therapy approach in patients with blood and bone marrow cancers for whom stem cell transplantation hasn’t worked. Results from the Resolve trial showed that 78% of patients responded to multi-tumor-associated antigen specific lymphocytes (TAA-L) treatment and 44% of patients […]
GlaxoSmithKline, Innoviva tout data for Relvar Ellipta inhaled drug combo
GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) touted data today from a non-inferiority lung function study evaluating its inhaled, once-daily corticosteroid/long-acting beta2 agonist combination therapy in patients with asthma. The study showed that patients with well-controlled asthma could switch from the twice-daily Seretide Accuhaler to the companies’ once-daily Relvar Ellipta therapy without compromising lung function. Patients who switched to […]
Meril’s bioresorbable, drug-eluting vascular scaffold
Meril Life Sciences has developed a drug-eluting, bioresorbable vascular scaffold that the body can slowly degrade and wash away. The company’s MeRes100 is made of biodegradable polymers, PLLA and PDLLA. Sirolimus, a commonly-used immunosuppressant found in drug eluting stents, is embedded in the scaffold’s coating. The company designed the struts of the device to be just 100 μm […]
TiGenix, Takeda highlight data for cell therapy in patients with Chron’s disease
Takeda (TYO:4502) and TiGenix (EBR:TIG) today touted long-term data from its phase III Admire-CD trial evaluating its suspension of allogenic expanded adipose-derived stem cells, Cx601, in patients with Chron’s disease. The study showed that Cx601 maintained long-term remission of treatment refractory complex perianal fistulas over 52 weeks. The randomized, phase III trial compared Cx601 to […]
Insulet touts Omnipod Horizon hybrid closed-loop system in patients with T1D
Insulet (NSDQ:PODD) touted data today from the 1st feasibility study of its Omnipod Horizon hybrid closed-loop system in patients with Type 1 diabetes. Data from the study showed that the Omnipod automated glucose control algorithm performed well, with minimal hypoglycemia, and that it was safe. The Billerica, Mass.-based company enrolled 24 patients with Type 1 diabetes […]
Clearside enrolls first patient in phase III trial of Zuprata combination therapy
Clearside Biomedical (NSDQ:CLSD) said today that it enrolled the 1st patient in a phase III trial evaluating Zuprata, its suspension formulation of triamcinolone acetonide, in combination with Eylea, intravitreal aflibercept, for the treatment of macular edema associated with retinal vein occlusion. The trial is slated to enroll 460 patients with retinal vein occulsion to assess […]
Novocure enrolls 1st patient in TTFields, chemo treatment lung cancer phase III trial
Novocure (NSDQ:NVCR) said today it enrolled the 1st patient in the phase 3 pivotal Lunar trial of its Tumor Treating Field technology for treating patients with advanced non-small cell lung cancer who have failed platinum-based therapy. The prospective, randomized 512-patient trial from the St. Helier, N.J.-based company aims to test the safety and efficacy of its […]