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  • AM‐Pharma B.V., a biopharmaceutical company focused on the development of recAP (recombinant human Alkaline Phosphatase) for inflammatory diseases, announces that it has received fast track designation from the U.S. Food and Drug Administration (FDA) for recAP to treat Acute Kidney Injury (AKI). Additionally, the Company reports that the interim analysis on the first stage of the adaptive Phase II trial in AKI has been successfully completed.

  • AstraZeneca announced that it has entered into a licensing agreement with Ironwood Pharmaceuticals for the exclusive US rights to Zurampic® (lesinurad). Zurampic was approved by the US Food and Drug Administration (FDA)in December 2015, in combination with a xanthine oxidase inhibitor (XOI), for the treatment of hyperuricemia associated with uncontrolled gout.

  • Astrazeneca announced that the US Food and Drug Administration has approved Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) inhalation aerosol indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

  • Rockwell Medical, Inc. (NASDAQ:RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, announced today that the U.S. Food & Drug Administration (FDA) has approved the New Drug Application for Triferic Powder Packet for commercial sale as an iron replacement product to maintain hemoglobin in adult patients with hemodialysis dependent chronic kidney disease. Triferic is the Company's innovative iron-replacement drug for the treatment of anemia in chronic kidney disease patients receiving hemodialysis.

  • Pfizer Inc. announced results published in The Lancet from the largest clinical trial of approved smoking cessation medicines, called EAGLES (Evaluating Adverse Events in a Global Smoking Cessation Study). This smoking cessation trial included 8,144 adult smokers and was designed to compare the neuropsychiatric safety of CHANTIX®/CHAMPIX® (varenicline) and bupropion with placebo and nicotine patch in adult smokers with and without a history of psychiatric disorders. The authors concluded that the trial did not show a significant increase in the incidence of the composite primary safety endpoint of serious neuropsychiatric adverse events with CHANTIX/CHAMPIX or bupropion compared to placebo and nicotine patch. Differences between incidence rates were considered significant if their associated 95% confidence intervals (CIs) were entirely above or below zero. Approximately half of the trial participants had a history of psychiatric disorders, either past and in remission or present and clinically stable. The psychiatric diagnoses included primarily depressive, bipolar, anxiety and psychotic disorders.

  • Swedish Orphan Biovitrum AB (publ) (Sobi), an international speciality healthcare company, announced that it has exercised its option to sign a licensing agreement with Swedish biotech company Affibody AB for the development of novel treatments for inflammatory diseases where interleukin-1 (IL-1) is involved.

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  • Abbott announced the global launch of AlinIQ, the first in a series of new innovations that Abbott will be bringing to diagnostics customers around the world over the next few years. AlinIQ is a first-of-its-kind professional services and informatics solution that will enable labs to deliver greater overall productivity with their existing resources.

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