Pharma News

Accuray seeks US FDA marketing approval for Radixact treatment delivery system

  • Posted on: 29 April 2016
  • By: Shalini.Sharma

Accuray Incorporated, a radiation oncology company, announced the submission of its 510(k) premarket notification with the Food and Drug Administration (FDA) for the company’s Radixact Treatment Delivery System. Accuray also submitted 510(k) premarket notification for its treatment planning and data management systems, Precision Treatment Planning System and iDMS Data Management System.


ChemoCentryx receives FDA oProducts development grant for orally administered complement 5a receptor inhibitor CCX168

  • Posted on: 29 April 2016
  • By: Shalini.Sharma

ChemoCentryx, Inc., announced that the U.S. Food and Drug Administration (FDA) has awarded the Company a one-year grant of $500,000 to assist in the clinical development of CCX168, the Company's lead drug candidate for the treatment of patients with anti-neutrophil cytoplasmic antibody (ANCA) -associated vasculitis, or AAV. CCX168 is an orally-administered small molecule that is a selective inhibitor of the complement C5a receptor, or C5aR.


FDA accepts resubmission of new drug application for RAYALDEE®

  • Posted on: 29 April 2016
  • By: Gayatri Mahajan

OPKO Health, Inc. announced the U.S. Food and Drug Administration (FDA) has accepted OPKO's resubmission on April 22, 2016 of the New Drug Application (NDA) for RAYALDEE® (calcifediol) for the treatment of secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.


Decoding Zika to fight future outbreaks

  • Posted on: 28 April 2016
  • By: Gayatri Mahajan

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.


Two Days National Symposium on Improving Healthoutcomes through Evidence based Practices

Raghavendra Institute of Pharmaceutical Education and Research (RIPER) in association with ISPOR India – Andhra Pradesh Chapter, Indian Pharmaceutical Association (IPA) Anantapuramu Branch and KVSR Siddhartha College of Pharmaceutical Sciences

A Two Days National Symposium on “Improving Healthoutcomes through Evidence based Practices” was organized by International Society for Pharmacoeconomics and Outcomes Research (ISPOR) India – Andhra Pradesh Chapter in association with Raghavendra Institute of Pharmaceutical Education and Research (RIPER), Indian Pharmaceutical Association (IPA) Anantapuramu Branch, Kommareddy Venkata Sadasiva Rao (KVSR) Siddhartha College of Pharmaceutical Sciences and International Society for Pharmacoeconomics and Outcomes Research (ISPOR) RIPER Student Chapter on 22nd & 23rd April 2016 at KVSR Siddhartha College of Pharmaceutical Sciences, Vijayawada, Andhra Pradesh.


Probiotics stop menopause-like bone loss in mice

  • Posted on: 28 April 2016
  • By: Gayatri Mahajan

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 receives USFDA approval for famotidine tablets (OTC)

  • Posted on: 28 April 2016
  • By: Shalini.Sharma

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 Receives FDA Approval for Xtampza™ ER

  • Posted on: 28 April 2016
  • By: Shalini.Sharma

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. 


Intuity Medical receive US FDA nod to market POGO Automatic Blood Glucose Monitoring System

  • Posted on: 28 April 2016
  • By: Shalini.Sharma

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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