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2/21/2018

Findings from a study reported in the Journal of Hepatology found that the drug Vesatolimod, or GS-9620, was well tolerated and safe to use in virally suppressed patients with chronic hepatitis B. The midstage study involved 162 patients from 23 international centers who received varying doses of Vesatolimod or placebo for 12 weeks.

2/21/2018

The European Medicines Agency said doctors should stop prescribing Allergan's Esmya, or ulipristal acetate, for uterine fibroids pending a safety review of the drug. The investigation of the drug was initiated after reports of four cases of serious liver injury after Esmya use, including liver failure leading to transplants in three of the cases.

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PharmaTimes (U.K.)
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European Medicines Agency, Esmya
2/21/2018

Three individuals who became ill from a salmonella outbreak linked to Fareway's chicken salad have filed civil suits in the US District Court for the Southern District of Iowa, seeking reimbursement for medical expenses and other costs from Fareway grocery stores. The outbreak numbers have already reached 115 cases of salmonella infection, in which 37 are confirmed with laboratory tests and 78 are probable cases.

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Food Safety News
2/21/2018

A rule requiring medical device clinical trials conducted in foreign countries to flexibly comply with Good Clinical Practice standards has been finalized by the FDA. An accompanying guidance on ensuring compliance of US and non-US studies with the final rule and modified regulations was also released by the agency.

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Regulatory Focus
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FDA
2/21/2018

Corindus Vascular Robotics' CorPath GRX system was granted 510(k) clearance by the FDA for use in peripheral vascular intervention procedures. The system, which was previously cleared for use in percutaneous coronary interventions, can now be used for treating both coronary artery disease and peripheral artery disease.

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MassDevice (Boston)
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Corindus Vascular Robotics, FDA
2/21/2018

Takeda Pharmaceutical will develop and commercialize with Wave Life Sciences nucleic acid treatments indicated for central nervous system diseases. Under the terms of the deal, Wave receives an upfront payment of $170 million, and Takeda gets an option to co-develop and co-commercialize Wave's WVE-120101, WVE-120102 and WVE-3972-01, as well as for a preclinical program targeting ataxin 3 for the treatment of spinocerebellar ataxia type 3.

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BioCentury
2/21/2018

Orthotaxy, a French company that develops software-enabled surgery technologies, was acquired by Johnson & Johnson through its French affiliate Apsis for undisclosed terms. J&J is aiming to expand the application of Orthotaxy's early-stage robotic-assisted surgery technology for total and partial knee replacement to include other orthopedic surgeries and hopes to develop a solution that is cost-effective, easy to use and saves time in various care settings.

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Johnson & Johnson, Orthotaxy
2/21/2018

About 89% of scientists from the American Association for the Advancement of Science say crops improved by modern biotechnology are safe for human consumption. Recent research showed that no differences have been found that implicate a higher risk to human health and safety from biotech foods versus their nonbiotech counterparts.

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ZME Science
2/21/2018

An addition of $1.5 billion to an existing share repurchasing plan of Baxter was approved by the company's board of directors, bringing the repurchase authority to $2.3 billion. Share repurchasing will be done through private transactions at amounts and times established by the company or in the open market.

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MassDevice (Boston)
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Baxter
2/21/2018

Medtronic's diabetes division saw a 17% increase in sales during the fiscal third quarter ending Jan. 26 and accounted for about 8% of the company's revenue after the MiniMed 670G system's completion of a priority access program. The company, which saw a shortfall in the supply of sensors for its diabetes devices, eyes market expansion with more products built on the same sensing technology and believes it can now meet future demand.

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Medtronic