Tuesday, December 4, 2018
Medtronic announces voluntary corrective action on ventilator series
Medtronic is notifying customers worldwide of a voluntary field corrective action for its Puritan Bennett 980 ventilator series. Medtronic initiated this field action on September 19, 2018. A Puritan Bennett 980 ventilator is a mechanical ventilator used to support a patient’s breathing. This prescription device is operated by trained healthcare professionals in an acute and or critical care clinical setting for neonatal, pediatric and adult patients. The voluntary field corrective action is a software update to address customer feedback. The software updates the external USB Drive performance and its impact on Graphical User Interface functionality and the labeling displayed on the GUI during ventilator use. The software update also provides additional product enhancements. Medtronic is currently updating all PB980 ventilators to this new software version at customer facilities.
https://thefly.com/landingPageNews.php?id=2832313
Insys Therapeutics presents results from long-term study of CBD oral solution
Pharmaceutical-grade cannabidiol oral solution made by INSYS Therapeutics was generally well-tolerated-even at high doses-as an investigational treatment for refractory pediatric epilepsy, according to new clinical data from a long-term safety study presented yesterday at the American Epilepsy Society 2018 annual meeting. “The results of this study support the promising safety profile of CBD oral solution from INSYS in the context of treating pediatric patients with intractable seizures due to epilepsy,” said James W. Wheless, M.D., professor and chief of pediatric neurology at the University of Tennessee Health Science Center in Memphis, where he directs the Neuroscience Institute & Le Bonheur Comprehensive Epilepsy at Le Bonheur Children’s Hospital and holds the Le Bonheur Chair in Pediatric Neurology. “In addition, these long-term safety data are consistent with those from other studies of CBD in refractory pediatric epilepsy.”
Veeva initiated at Leerink
Veeva initiated with an Outperform at Leerink. Leerink initiated Veeva with an Outperform and $120 price target.
Foamix remains ‘substantially undervalued,’ says H.C. Wainwright
H.C. Wainwright analyst Raghuram Selvaraju raised his price target for Foamix Pharmaceuticals to $12 from $11 citing the positive top-line results from two pivotal Phase 3 clinical trials of FMX103 for the treatment of moderate-to-severe papulopustular rosacea. The analyst believes the high level of statistical significance underscores the degree of efficacy observed. He reiterates a Buy rating on Foamix and says the stock remains “substantially undervalued.”
Cantor sees value in Vanda despite 26% rally, upgrades to Overweight
Cantor Fitzgerald analyst Charles Duncan upgraded Vanda Pharmaceuticals to Overweight from Neutral and raised his price target for the shares to $43 from $26. The analyst is “impressed” with the effect size magnitude for tradipitant in the Phase 2 study in patients with idiopathic and diabetic gastroparesis. This points to a clinically meaningful increase in nausea-free days, indicating a clear improvement in patient quality of life, Duncan tells investors in a research note. The analyst sees value in the shares despite yesterday’s 26% rally.
Anthem price target raised to $330 from $305 at Cantor Fitzgerald
Cantor Fitzgerald analyst Steven Halper raised his price target for Anthem to $330 after management said in investor meetings that it will use $3.2B from its pharmacy benefit manager savings beginning in 2020 and 2021 to drive membership growth in subsequent years. Accordingly, the analyst increased his top-line growth assumptions. He expects membership and revenue to grow faster without sacrificing margins and keeps an Overweight rating on Anthem.
TG Therapeutics presents data from ublituximab trial at ASH
TG Therapeutics announced updated clinical data from its Phase I/Ib trial of ublituximab, the company’s novel glycoengineered anti-CD20 monoclonal antibody in combination with umbralisib, the company’s oral, next generation PI3K delta inhibitor, and bendamustine, in patients with Diffuse Large B-cell Lymphoma, or DLBCL, and Follicular Lymphoma, or FL. Data from this trial was presented yesterday evening during a poster session at the American Society of Hematology, or ASH. This poster presentation includes data from patients with relapsed or refractory DLBCL or FL treated with the triple combination of umbralisib, ublituximab and bendamustine. Thirty-nine patients were evaluable for safety of which 38 were evaluable for efficacy. Twenty-two patients were refractory to prior treatment. Overall, the triple combination was well tolerated and highly active in patients with advanced indolent and aggressive NHL, including those not eligible for HD/SCT or CD19 CART therapy.
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