Pharma News

The constant emergence of viral outbreaks has become a permanent threat to human health. Last year, Zika virus infected thousands of people in the Americas. It is also associated to several cases of neurological disorders and has raised worldwide public health alerts. Now due to the urgency, researchers are detailing the characteristics of the virus to find solutions.

Probiotic supplements protected female mice from the loss of bone density that occurs after having their ovaries removed, researchers at Emory University School of Medicine and Georgia State University have shown.The results were published Monday, April 25 in Journal of Clinical Investigation.

Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Famotidine Tablets USP, 10 mg and 20 mg (OTC). This product is expected to be launched in Q2 FY16-17.

Collegium Pharmaceutical, Inc. announced that the U.S. Food and Drug Administration (FDA) approved Xtampza™ ER (oxycodone) extended-release (ER) capsules CII, a twice-daily, oxycodone medication for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. 

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.

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.