Boston Scientific over the summer unveiled a new value-add for its implantable cardio devices: an online Trugevity calculator that lets physicians predict battery life. The idea is to help health providers quickly grasp the benefits of Boston Sci's longer-lasting EnduraLife battery technology, which the company touts has nine clinical studies and eight years of real-world data to back up its abilities. "We used to do those [battery life] calculations in-house … for physicians who are interested. … We decided, 'Why not let the truth be free?'" said Ken Stein, SVP and CMO for rhythm management and global health policy at Boston Sci. Read the story.
The FDA approved GlaxoSmithKline and Innoviva's triple drug inhaler Trelegy Ellipta, a combination of fluticasone furoate, umeclidinium and vilanterol, as a treatment for patients with chronic obstructive pulmonary disease. The companies said the drug was not indicated for treatment of asthma or acute bronchospasm.
Perrigo's generic version of Valeant Pharmaceuticals' Acanya, or clindamycin phosphate and benzoyl peroxide gel, for the treatment of acne was granted tentative approval by the FDA.
The FDA allowed DelMar Pharmaceuticals to add an investigational new drug application for its VAL-083 for a study of the drug as a treatment for patients with recurrent platinum-resistant ovarian cancer. The clinical trial will be a multicenter Phase I/II study that will investigate the drug's ability to overcome chemo resistance and will evaluate progression-free survival, response duration and certain biomarker levels in the blood.
A recall was issued by German Sausage Haus for 1,252 pounds of meat products, covering 12 varieties of meats with 15 different packing codes, because of possible contamination with staphylococcal enterotoxin. The Food Safety and Inspection Service discovered a food processing deviation, which spurred the recall, while reviewing the records of the company.
Smiths Medical said it has not received reports of hacking involving its Medfusion 4000 drug infusion pumps that, according to a Department of Homeland Security advisory, contain cybervulnerabilities, but the company has already recommended immediate actions for the secure use of the devices. The company is looking to release new software for versions 1.1, 1.5 and 1.6 of the pumps in January and is resolving the issue in collaboration with the DHS and the Industrial Control Systems Cyber Emergency Response Team.
The Intellis system, a next-generation spinal cord stimulator developed by Medtronic for chronic intractable pain management, was launched in the US after receiving approval from the FDA. The system, controlled using a Samsung Galaxy Tab S2 tablet interface, comes with an implantable pulse generator for delivering mild current to the epidural space in the spine and a feature for balancing low- and high-dose settings and standardizing recommended medical guidance.
Three-year follow-up cohort data from an open-label study in the European Respiratory Journal showed positive results for the use of Boston Scientific's Alair system in bronchial thermoplasty to treat patients with severe persistent asthma. Use of the system demonstrated a 34% reduction in severe asthma-related exacerbations, a 16% decrease in emergency department visits, an 8% drop in hospitalizations and a 9% reduction in the use of daily maintenance oral corticosteroids.
The NIH awarded a $4 million grant to Pain Therapeutics to support the company's development of an Alzheimer's disease blood test based on Pain's PTI-125 for Alzheimer's disease and the Fenrock fentanyl transdermal patch for the treatment of severe pain.
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