Pharma News

The US Food and Drug Administration (FDA) has granted marketing approval for Intuity Medical's POGO Automatic Blood Glucose Monitoring System.The POGO System is the first blood glucose meter and multi-test cartridge to provide automatic testing with lancing, blood collection and analysis in one easy step. By combining all of the necessary blood glucose testing supplies into a convenient, self-contained 10-test cartridge, POGO provides ease of use and discretion for millions of patients who need to regularly test their blood glucose in the management of their diabetes.

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Pharnext,  announced the opening of the first US trial site for its PLEO-CMT pivotal phase 3 clinical trial of its lead pleodrug PXT3003 in Charcot-Marie-Tooth disease type 1A (CMT1A). The clinical trial, which began enrolling patients in December 2015 in Europe, is intended to determine whether PXT3003 is effective and well tolerated in patients with CMT1A. PXT3003, developed using Pharnext's Pleotherapy R&D platform, is an oral fixed-low dose combination of (RS)-baclofen, naltrexone hydrochloride and D-sorbitol.

When retroviruses such as HIV infect a cell, they first make a copy of their RNA genome in the form of DNA. The relatively short viral DNA strand then moves to the cell nucleus, where it inserts itself into the host cell's DNA.

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.

Mexican researchers developed a nanogel that enables the growth of new neurons.Working with animal models, Mexican researchers were able to cross the electroencephalic barrier, introduce a nanogel and achieve the growth of neurons within the gel, which shows that it is possible to promote regeneration of brain tissue.

The U.S. Food and Drug Administration announced a proposal to ban electrical stimulation devices (ESDs) used for self-injurious or aggressive behavior because they present an unreasonable and substantial risk to public health that cannot be corrected or eliminated through changes to the labeling.

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.