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11/14/2018

A major FDA initiative to fight smoking and vaping among underage youths will be launched this week and include action against flavored products, said FDA Commissioner Scott Gottlieb. Meanwhile, Juul Labs said it will pull e-cigarette products with cucumber, mango and other popular flavors from retail stores until age-verification technology can be installed, and the company said it would also take action to stop promotion of its products on Facebook and Instagram to curb teen e-cigarette use.

11/14/2018

Scientists used stem cells to make a lifelike human atrium model that beats, expresses genes and responds to drugs, and it could be used for testing experimental treatments for atrial fibrillation. The scientists started developing the model over two decades ago using embryonic chicken heart cells and applied the technique to rat and mouse cells before using human cells, and they have tested patches for damaged hearts in rats and guinea pigs. The patches are now being tested in pigs, with human testing on the horizon.

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Digital Trends
11/14/2018

The CMS sent a letter to state Medicaid directors Tuesday urging states to apply for new waivers enabling expanded coverage of inpatient care at institutions of mental disease. The waiver will apply to all Medicaid beneficiaries, not just those in managed care, and will allow for 30 days of care for severe mental illness.

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CMS, Medicaid
11/14/2018

The FDA has granted Becton Dickinson clearance to market its BD Phoenix CPO detect test, which is intended to detect antimicrobial-resistant infections and other infections caused by carbapenemase-producing organisms.
The phenotypic test, which takes less than 36 hours to provide results, will be offered as part of the company's Phoenix gram-negative panels and will be released in January.

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BioWorld MedTech
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Becton Dickinson, FDA, Phoenix
11/14/2018

The FDA has given bioMerieux affiliate BioFire Diagnostics 510(k) clearance for its polymerase chain reaction-based panel assay, the BioFire FilmArray Pneumonia Panel, which detects 33 common lower respiratory tract infection-causing pathogens in bronchoalveolar lavage and sputum samples. The Plus version of the panel, which can also detect the MERS-CoV virus, received CE mark approval from European regulators.

11/14/2018

European regulators have granted Medtronic CE mark approval for its Valiant Navion thoracic stent graft system for the minimally invasive repair of all lesions of the descending thoracic aorta, such as blunt traumatic aortic injuries, intramural hematomas, penetrating atherosclerotic ulcers, thoracic aortic aneurysms and type B aortic dissections.

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Seeking Alpha
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EU
11/14/2018

A new dosing option for Amgen's Kyprolis, or carfilzomib, has been approved by the FDA as a treatment for relapsed or refractory multiple myeloma. The new dosing option, Kd70, is combined with dexamethasone and can be taken once weekly.

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Drug Store News
11/14/2018

The FDA accepted for review Ardelyx's marketing application for tenapanor, which is being developed for patients with irritable bowel syndrome with constipation.

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Seeking Alpha
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FDA, Ardelyx, tenapanor
11/14/2018

The FDA has signed off on Sutro Biopharma's investigational new drug application for STRO-002, being developed as a treatment for patients with ovarian and endometrial cancers. The company intends to launch an early-stage study of the candidate next quarter.

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Seeking Alpha
11/14/2018

Treatment of patients with relapsed/refractory acute myeloid leukemia with the combination of Opdivo, or nivolumab, and Vidaza, or azacitidine, induced improved outcomes and longer survival compared with historical benchmarks, with 33% of 70 participants exhibiting objective responses to the regimen and 22% attaining complete responses. Details of the research were reported in Cancer Discovery.

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Vidaza