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11/22/2017

Postdoctoral research fellow Christine Lattin studies non-native house sparrows' stress response not only to learn how to help animals as well as people survive extreme stress, but also to develop noninvasive research methods. Lattin has been targeted recently by animal rights activists and has become more vocal about her research in the hope of better educating the public about the benefits of animal research.

11/21/2017

Medtronic is touting its new CPT codes for the VenaSeal varicose vein closure device -- codes that company officials think bring the device closer to positive coverage from public and private insurers in the US. The CMS announced the new codes on Nov. 1 as part of final rules for the 2018 Medicare Physician Fee Schedule (CMS-1676-F) and Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems (CMS-1678-FC), according to Medtronic officials. The VenaSeal system uses a proprietary adhesive to close superficial veins in lower extremities in people suffering from symptomatic venous reflux, or varicose veins. The procedure, however, remains under a self-pay model since its FDA clearance and US launch in 2015. Read the story.

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Medtronic
11/21/2017

Concentrations of five microRNAs in saliva yielded 85% accuracy in identifying youths whose concussion symptoms persisted one month after injury, compared with about 65% accuracy using the Standardized Concussion Assessment Tool 3, researchers reported in the journal JAMA Pediatrics. The findings were based on data involving 52 children with concussions ages 7 to 21.

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CNN, National Public Radio
11/21/2017

Intra-Cellular Therapies' schizophrenia drug candidate lumateperone was granted fast-track designation by the FDA.

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FDA, Intra-Cellular Therapies
11/21/2017

The FDA gave orphan drug status to Revance Therapeutics' daxibotulinumtoxina injection, or RT002, which is being developed as a treatment for patients with cervical dystonia.

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Reuters
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Revance Therapeutics, FDA
11/21/2017

Late-stage studies of the Parkinson's disease candidate tozadenant were suspended by Acorda Therapeutics and development of the drug was halted after the deaths of five patients who developed agranulocytosis-associated sepsis during the trials. The company, which will immediately stop the dosing of the remaining patients enrolled in its studies, said the decision came after it received new information from the trials "related to previously disclosed agranulocytosis and associated serious adverse events."

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Parkinson, Acorda Therapeutics
11/21/2017

Tasigna, or nilotinib, a drug developed by Novartis as a treatment for pediatric patients diagnosed with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase, gained approval from the European Commission and is indicated for use in the frontline setting or for those who experienced resistance or were intolerant to other treatment regimens.

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OncLive
11/21/2017

The Nov. 15 recall of Casa Sanchez Foods' Real Guacamole has expanded to include Spicy Guacamole because of possible Listeria monocytogenes contamination. The expansion includes five lots with the UPC 0 78732 00431 3, 11 lots with the UPC 0 78732 00426 9 and 21 lots with the UPC code 0 78732 00412 2, which were shipped to California, Hawaii and Nevada.

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Casa Sanchez Foods, Listeria
11/21/2017

Medtronic obtained approval from the FDA for its Azure XT MRI and Azure S MRI pacemakers, which are designed for bradycardia treatment, and announced the US launch of the devices. The pacemakers, which feature the company's Reactive ATP pacing algorithm and BlueSync secure wireless remote monitoring capability to prevent against device hacking, come in single- and dual-chamber models and have 27% greater longevity than their predecessor.

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Medtronic, FDA
11/21/2017

The first human trial of the FDA-approved DiLumen Endolumenal Interventional Platform, a single-use sleeve intended for stabilizing colonoscopes, was completed by Lumendi, showing the device was safe to use during routine colonoscopy without any serious adverse events. The observational registry study met its primary safety endpoint, which was the absence of significant mucosal injuries, and its primary study endpoint, which was the ability of scope navigation with the device to the cecum.