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4/19/2019

HHS Secretary Alex Azar said a new study in Kentucky, Ohio, Massachusetts and New York communities seeks to identify the best ways to address the opioid crisis at the local level and to reduce opioid overdose deaths by 40% over three years in those communities. The study will be funded with $350 million in research grants.

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Alex Azar, HHS
4/19/2019

The Montana House voted to approve a bill that would extend the state's expanded Medicaid program for an additional six years. The legislation, which now heads to Gov. Steve Bullock, would impose work requirements on Medicaid beneficiaries and raise premiums for those who remain in the program for over two years.

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The Associated Press
4/19/2019

Genfit's elafibranor, which is being developed to treat adult patients with primary biliary cholangitis who respond inadequately to ursodeoxycholic acid, was given breakthrough therapy status by the FDA. In a midstage trial, treatment with elafibranor demonstrated positive effect in noncirrhotic patients with PBC and inadequate UDCA response.

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eMPR
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FDA, GENFIT, PBC
4/19/2019

Moleculin Biotech's Annamycin, which is being developed as a treatment for patients with relapsed or refractory acute myeloid leukemia and is in early-stage and midstage trials, has been granted fast-track designation by the FDA.

4/19/2019

Advanced Prenatal Therapeutics' Targeted Apheresis Column for Preeclampsia was given breakthrough therapy designation by the FDA.

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MedTech Dive
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FDA
4/19/2019

Beckman Coulter has received 510(k) clearance from the FDA for its Early Sepsis Indicator, which sends a positive result for a higher probability of sepsis and signals a negative result for lower sepsis probability.

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MD Magazine online
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Beckman Coulter, FDA
4/19/2019

The FDA has granted 510(k) clearance for Collagen Matrix's OssiMend, a spinal bone graft that can be molded into putty to permit bony ingrowth in irregular defect sites. The bone graft, which is composed of bioactive glass, highly purified collagen and anorganic bone mineral, is available in several sizes for complex surgeries.

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FDAnews
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Collagen Matrix, FDA
4/19/2019

Senate Majority Leader Mitch McConnell, R-Ky., said he plans to introduce a bill that would raise the minimum age from 18 to 21 for purchasing tobacco products. McConnell said the increasing rate of vaping among teenagers and young adults motivated the idea for the legislation, which is expected to be introduced in May.

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Reuters
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Mitch McConnell, Senate
4/19/2019

Viela Bio's inebilizumab, being developed as a monotherapy for neuromyelitis optica spectrum disorder, has been given breakthrough therapy status by the FDA. The decision was backed by preliminary data from an ongoing study, which demonstrated a 77% lower risk of developing an NMOSD attack during treatment with inebilizumab versus placebo use.

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eMPR
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Viela Bio, FDA
4/19/2019

A final guidance was published by the UK's National Institute for Health and Care Excellence endorsing UCB's Cimzia, or certolizumab pegol, as a treatment for patients with severe plaque psoriasis who do not respond to or cannot take other systemic therapies.