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6/18/2018

House lawmakers passed 38 bills aimed at combating the opioid-abuse epidemic last week, including measures that would give the National Institutes of Health more authority to study nonaddictive painkillers and prevent opioid smuggling through international mail. The House expects to pass this week at least another 19 opioid measures and a legislative vehicle that would wrap in all of the opioid bills passed by the chamber, with the goal of sending the bills to the Senate this summer.

6/18/2018

Bluebird bio reported at the European Hematology Association meeting last week that changes to its gene therapy candidate LentiGlobin boosted the experimental therapy's efficacy based on results from its early-stage study. The trial consists of four patients with sickle cell disease, who are now producing a median of 39% of healthy hemoglobin in their blood after receiving the treatment.

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Xconomy
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Bluebird Bio
6/18/2018

Regenxbio's RGX-111, being developed as a treatment for patients with mucopolysaccharidosis type 1, received fast-track status from the FDA.

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eMPR
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mucopolysaccharidosis, FDA, Regenxbio
6/18/2018

Teva Pharmaceutical Industries will halt a late-stage study evaluating the safety and efficacy of TEV-48125, or fremanezumab, in patients with chronic cluster headaches. The company said the trial is unlikely to meet the primary endpoint of reducing the number of headaches.

6/18/2018

Kyowa Hakko Kirin's Crysvita, or burosumab, was turned down by the National Institute for Health and Care Excellence for funding by the National Health Service as a therapy for young patients with X-linked hypophosphatemia. The institute ruled that the drug's benefit did not meet cost-effectiveness standards.

6/18/2018

Bristol-Myers Squibb's Opdivo, or nivolumab, was approved by China's State Drug Administration for use as a treatment for adult patients with locally advanced or metastatic non-small cell lung cancer after platinum-based chemotherapy who have no EGFR or ALK mutations.

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BioCentury
6/18/2018

Del Monte Food recalled some of its vegetable trays after they were linked to a cyclospora illness outbreak that sickened 78 people. Affected in the recall were Del Monte trays that contain cauliflower, broccoli, carrots and dill dip that were sold in Iowa, Minnesota and Wisconsin, as well as similar small vegetable trays distributed in Illinois and Indiana.

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WGN-TV (Chicago)
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Del Monte, Del Monte
6/18/2018

The FDA has granted Medtronic approval for the 200- and 250-millimeter lengths of its In.Pact Admiral drug-coated balloon for long superficial artery lesion treatment in patients with peripheral artery disease. The approval was backed by a global study of the device, which demonstrated an 89.1% patency rate at one year and a 7.1% clinically driven target revascularization rate among patients with lesions more than 180 mm long.

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Medtronic
6/18/2018

European regulators have given Q3 Medical Devices' AMG International CE mark approval for its Archimedes biodegradable biliary and pancreatic stent, which is indicated to be used in obstructed biliary or pancreatic ducts. The device is intended to completely degrade by means of hydrolysis in 12, 20 or 77 days, depending on its composition.

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MassDevice (Boston)
6/18/2018

Acceleron Pharma's luspatercept demonstrated treatment benefit in two midstage trials evaluating the drug in patients with beta thalassemia, according to a presentation at the meeting of the European Hematology Association.
The data showed 41% of transfusion-dependent patients experienced at least a 33% reduction in red blood cell transfusion burden, while 53% of the non-transfusion-dependent group achieved at least a 1 g/dL increase in hemoglobin from baseline.

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Seeking Alpha