Insightec said today it won FDA approval to launch a safety and feasibility trial of its Exablate Neuro, testing its ability to disrupt the blood brain barrier in patients with glioblastoma. The Exablate Neuro device, which won FDA approval last July for treating essential tremor, uses high-intensity, focused ultrasound to thermally ablate targeted tissue, guided by […]
Shares in Egalet Corp. (NSDQ:EGLT) soared this morning in pre-market activity after the company reported that its abuse-deterrent, extended-release oxycodone candidate met the primary endpoint of a Phase III pain relief trial. The Wayne, Penn.-based company compared the efficacy and safety of its product to a placebo in opioid-experienced and opioid-naïve patients with moderate-to-severe chronic low back […]
GlaxoSmithKline (NYSE:GSK) is slated to use Owlstone Medical‘s breath biopsy device in a phase II trial of its drug for chronic obstructive pulmonary disease, danirixin. The diagnostics company’s breathalyzer will be used to help GSK identify which patients will most benefit from the drug, as well as evaluate the effects of danirixin, according to the pharma company. Get […]
Bayer (ETR:BAYN) reported last week that its antibiotic drug-device combination product failed in a phase III trial. In the 725-patient Inhale trial, Bayer’s Amikacin Inhale did not out-perform a placebo as a treatment for Gram-negative pneumonia in patients on ventilators. Get the full story at our sister site, Drug Delivery Business News.
GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) have submitted data from the landmark Impact trial to the FDA in the hopes of landing an expanded label for the Trelegy Ellipta triple inhaler. The two companies are hoping that their therapy could be used to treat airflow obstruction and to reduce exacerbations in people with chronic obstructive pulmonary disease. Get the […]
The world’s largest diabetes drug-maker, Novo Nordisk (NYSE:NVO), is reportedly looking to boost its efforts to treat obesity as the company’s well-established diabetes drugs face competition. At Novo Nordisk’s capital markets day yesterday, CEO Lars Fruergaard Jorgensen told investors that the company wants to rival surgery with their drugs as a solution for obesity. The drug-maker’s first […]
Staar Surgical (NSDQ:STAA) this week reported results from the feasibility clinical study of its Evo+ Visian ICL with aspheric optics designed to reduce presbyopia, and that based on the results it plans to launch a pivotal clinical study of the device during the 1st quarter next year. The Monrovia, Calif.-based company’s EVO+ Visian ICL is designed […]
iVeena Delivery Systems said earlier this month that it finished a pilot trial for its IVMED-10 bioerodible implant designed to treat pain and inflammation after cataract surgery. Placed during cataract surgery, the sustained-release implant delivers dexamethasone for two weeks from the lens capsule. Get the full story at our sister site, Drug Delivery Business News.
Smith & Nephew (NYSE:SNN) today released results from a trial of its Allevyn Life multi-layer polyurethane dressing used in treating elderly patinets with hip fractures, touting reduced onset of pressure ulcers. Results from the trial were presented at the European Pressure Ulcer Advisory Panel annual meeting this year, the company said. Data in the trial came […]
EBR Systems said yesterday that it raised $50 million to back a clinical trial for the wireless cardiac pacemaker it’s developing after winning CE Mark approval for a second-generation wireless transmitter. EBR’s device, which it calls wireless stimulation endocardially or Wise, uses a subcutaneous generator to wirelessly deliver ultrasound energy to a “pellet” implanted in the […]
Update: Corrected from previously mislabeled ‘interarterial’ to ‘interatrial’ shunts Corvia Medical said today it launched the Reduce LAP-HF II clinical trial of its transcatheter Interatrial Shunt Device designed to treat heart failure as it seeks FDA approval of the device. The Tewksbury, Mass.-based company said the 1st patient in the trial was enrolled by Dr. Rami Kahwash […]