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Top regulatory issues to watch in 2017
Rachel Beavins Tracy, IQMS 2017 proves to have some big changes in store for life sciences companies. The new Trump administration brings changes in key areas such as the Affordable Care Act and...
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NuVasive launches Reline Trauma posterior fixation portfolio
NuVasive Inc. (NSDQ:NUVA) said yesterday it launched its Reline Trauma spinal posterior fixation portfolio designed to aid in the preservation and restoration of patient alignment. The San Diego,...
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Targeted drug delivery system releases chemo drug for 40 days
Researchers at Case Western Reserve University have developed a targeted drug delivery system that is triggered by the acidic environment around a tumor. The system delivers chemotherapy to the tumor...
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Report: GOP nearing completion on new Healthcare bill, but finds support split
Republican lawmakers are closing in on a reworked healthcare bill that looks to begin dismantling and replacing Obamacare, according to a report from The Hill. Freedom Caucus chair Rep. Mark Meadows...
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FDA clears Halyard’s Coolief RF device for treating OA pain
Halyard Health (NYSE:HYH) said today it won FDA clearance for its Coolief cooled radiofrequency thermal system designed for treating moderate to severe chronic osteoarthritis knee pain The Alpharetta,...
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Teva launches AirDuo RespiClick, generic inhaled asthma therapies
Teva Pharmaceutical (NYSE:TEVA) said today that it launched the AirDuo RespiClick inhalation therapy and its authorized generic in the U.S. for asthma patients who are uncontrolled on an inhaled...
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Clearside closes patient enrollment in trial for diabetic macular edema therapy
Clearside Biomedical (NSDQ:CLSD) said today that it finished enrollment for the Phase 1/2 study of CLS-TA in patients with diabetic macular edema. The Hulk trial is designed to evaluate the safety and...
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Medicaid expansion tied to increase in prescriptions for diabetes drugs,...
The number of prescriptions filled by adults using Medicaid rose 19% in states that expanded Medicaid compared to states that did not under the Affordable Care Act, according to a new study from the...
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Sandhill Scientific, Medovations merge to form Diversatek Healthcare
Gastroentological device developers Sandhill Scientific and Medovations announced today they will merge and take on their holding company’s name, operating as Diversatek Healthcare. The merger will...
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UniQure pulls first gene therapy from market in Europe
The Western world’s 1st gene therapy will not return to the European market after its 5-year conditional approval expires on Oct. 25 this year, according to UniQure (NSDQ:QURE). The company’s Glybera...
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J&J’s DePuy picks up bioresorbable 3D printing tech from Tissue Regeneration...
Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Synthes said today it acquired 3D printing technology assets from Tissue Regeneration Systems for an undisclosed amount. DePuy said it will use the...
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Cardiac Insight wins FDA nod for Cardea Solo wearable ECG sensor
Cardiac Insight said today it won FDA 510(k) clearance for its Cardea Solo wearable electrocardiogram sensor. The Cardea Solo device is designed to provide both physicians and patients with cardiac...
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Insightec touts 1st patient treated in Exablate Neuro FDA feasibility trial
Insightec today announced that the 1st patient has been treated in a feasibility trial exploring the use of its Exablate Neuro system for treating benign centrally-located intracranial tumors in...
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Eyevensys wins approval to start clinical development of EyeCET platform
Private biotech Eyevensys said today that it won approval from the UK Medicines and Healthcare Products Regulatory Agency to advance its EyeCET platform into clinical development. The company’s EyeCET...
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Malaysian combination product regulatory policy deadlines set
By Stewart Eisenhart, Emergo Group Malaysian medical device and drug market regulators have established a July 2018 implementation and enforcement deadline for combination product registrations...
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Stable blood sugar linked to heart stent outcomes
Patients with type 2 diabetes and a coronary stent are at lower risk for heart attack and stroke if they maintain good blood sugar control, according to a recent study. “Although intensive glucose...
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PMD’s at-home spirometry could improve medication adherence in cystic...
PMD Healthcare touted data today from a pediatric cystic fibrosis study which the company said demonstrates the feasibility of at-home spirometry using its Spiro PD device. Cystic fibrosis patients...
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Abbott issues select recall for NC coronary dilation & balloon caths
Abbott (NYSE:ABT) has issued an urgent field safety notice looking to recall select coronary dilation and balloon catheters over issues with inflating and deflating the balloons. The company said it is...
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SteadyMed raises $30m for Trevyent commercial launch
Shares in SteadyMed (NSDQ:STDY) rose 6% today after the company said it inked a $30 million private placement with Adage Capital Management, OrbiMed, Deerfield Management and Kingon Capital Management....
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23andMe is back: FDA allows marketing of genetic health risk tests
[Image courtesy of 23andMe]FDA this month allowed genetic testing company 23andMe to market genetic health risk tests for 10 diseases and conditions including Parkinson’s disease and late-onset...
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