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5/20/2019

A Government Accountability Office report found the CMS is not doing enough to ensure the public knows about major changes to Medicaid, particularly the implementation of work rules through Section 1115 waivers. To improve transparency and avoid inconsistencies, the report urges the CMS to create standard transparency rules for new waivers, extension requests and major changes under Section 1115.

5/20/2019

Patients with diabetes are being warned by the FDA against creating a do-it-yourself artificial pancreas system for blood glucose control after an individual experienced an accidental insulin overdose that required medical intervention. Use of such devices may "lead to injuries requiring medical intervention, such as severe low blood sugar, coma, diabetic ketoacidosis -- the buildup of acids in blood -- and death," the FDA said.

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FDA
5/20/2019

Medtronic has announced the launch of its Telescope Guide Extension Catheter for delivering coronary stents and balloons. The FDA-cleared and CE-marked catheter has a round pushwire that comes with a coil-reinforced hydrophilic-coated distal segment for accessing difficult lesions.

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Compelo
5/20/2019

MagStim secured 510(k) clearance from the FDA for its StimGuide transcranial magnetic stimulation navigation system, which is intended for facilitating coil positioning during major depressive disorder treatments.

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MassDevice (Boston)
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FDA
5/20/2019

European regulators have granted DiaSorin Molecular CE mark approval for its Simplexa HSV 1/2 and VZV Universal Direct MDx assay, a real-time PCR diagnostic designed for detecting and differentiating between herpes simplex viruses 1 and 2 and the varicella-zoster virus. The assay requires minimal hands-on interaction and takes about an hour to produce results without the need for upfront extraction.

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FDAnews
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VZV Universal Direct, EU
5/20/2019

The UK's National Institute for Health and Care Excellence could soon make Celgene's Revlimid, or lenalidomide, available as a first-line and second-line treatment to more multiple myeloma patients in England and Wales. NICE issued a final draft guidance recommending the therapy combined with dexamethasone for previously untreated adult multiple myeloma patients who can't take thalidomide and are ineligible for a stem cell transplant.

5/20/2019

Achillion Pharmaceuticals unveiled preliminary data from its midstage trial assessing the efficacy and safety of its factor D inhibitor candidate ACH-4471 as a treatment for paroxysmal nocturnal hemoglobinuria. The data were presented at The New Era of Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria meeting.

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Seeking Alpha
5/20/2019

A cell therapy, SIG-001, jointly developed by Sigilon Therapeutics and scientists from MIT, was able to correct bleeding and sustain factor VIII production for more than six months in a mouse model of hemophilia A. Data from the study were presented at the 2019 annual meeting of the American Society of Gene and Cell Therapy.

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Hemophilia News Today
5/20/2019

A round of Series B funding has pulled in $21.7 million for Actuate Therapeutics, which intends to use the proceeds to advance study of its GSK3B inhibitor into Europe, as well as its pediatric neuroblastoma program.

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BioCentury
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Actuate
5/20/2019

Consumers are misinformed by GMO-free labels, writes crop and cattle farmer Deb Gangwish, who adds that although biotech crops are proven safe, the presence of GMO-free product labeling, which appears even on foods like salt that have no genes to edit, tends to scare consumers rather than inform them.