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9/20/2019

Tandem Diabetes Care reported that a 45% relative risk reduction in hypoglycemia was observed in over 8,000 users of its t:slim X2 insulin pump. There was also a 71% relative risk reduction in hypoglycemic events.

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Tandem Diabetes Care
9/20/2019

Biedermann Motech has unveiled its Moss VRS pedicle screw technology, which allows surgeons to lock and unlock the polyaxial angle of the pedicle screw at any angle or time during correction and reconstruction procedures.

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Becker's Spine Review
9/20/2019

The FDA has cleared OrthoSpin's external robotic fixation system that makes automatic preprogrammed adjustments for patients undergoing orthopedic treatment.

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Becker's Spine Review
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FDA
9/20/2019

Viseon's Voyant System for integrating minimally invasive surgical access technology with real-time imaging has received FDA clearance. The device is excepted to see a full launch in the second half of next year.

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Becker's Spine Review
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FDA
9/19/2019

Novartis AG unit Sandoz said it will stop distributing generic versions of heartburn drug Zantac following the discovery of contaminants. The move comes after an investigation in the US and EU into the presence of N-nitrosodimethylamine and a Health Canada request for drugmakers to halt distribution for the time being.

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Reuters
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Novartis, heartburn, Health Canada
9/19/2019

House Speaker Nancy Pelosi, D-Calif., today is expected to unveil a proposal to address prescription drug prices, and she is reportedly planning to move quickly on efforts to pass it. The bill is not expected to differ significantly from a draft framework leaked last week, and it could include provisions that would allow the US government to negotiate drug prices and link the costs of some US drugs to what's charged in other countries, sources say.

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Nancy Pelosi
9/19/2019

It's OK to take the first step in discussing issues related to your career with your superior, particularly if you want more challenging assignments and feedback, writes personal branding coach William Arruda. He also advises how to prepare a mentorship request and a case for a flexible schedule.

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Forbes
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William Arruda
9/19/2019

Roche's Gazyva, or obinutuzumab, approved as a treatment for
lymphoma, was granted breakthrough therapy designation for a new indication, lupus nephritis. Data supporting the status granted by the FDA was based on results from a midstage trial that showed use of Gazyva in combination with existing standard of care was superior to placebo in terms of complete renal response at 12 months.

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PMLive (UK)
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FDA, Gazyva, Roche, nephritis, lupus
9/19/2019

Novartis announced it will seek approval for a fourth indication for its drug Cosentyx, or secukinumab, to treat axial spondyloarthritis. The company will use data from its late-stage PREVENT trial, which met the study's primary endpoint by achieving Assessment in SpondyloArthritis International Society 40% response in patients with non-radiographic axial spondyloarthritis, to support the FDA submission, and has also filed a marketing application with the European Medicines Agency for the approval of Cosentyx for nr-axSpA.

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PMLive (UK)
9/19/2019

The FDA approved an expanded indication for Janssen's oral androgen receptor inhibitor Erleada, or apalutamide, with the addition of coverage for men with metastatic castration-sensitive prostate cancer.

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FDA, Janssen, Erleada