Viteava Pharmaceuticals recently announced that they have entered into a sponsored research agreement with McGill University, aimed at investigating flavonoids. The research studies will focus on novel analogs and derivatives of the flavonoid associated with green tea, also known as epigallocatechin-3-gallate or EGCG
A research study conducted by The Cancer Genome Atlas (TCGA) Research Network, revealed that specific subtypes of bladder cancer resemble other subtypes of cancers such as those related to the breast, head, neck and lungs; suggesting that these subtypes of cancers may have related routes in their developmental stages.
Covidien announced that the FDA gave the green light for the company to manufacture and market their LigaSure Maryland Jaw - an open/ laparoscopic sealer/ divider and newest addition to the company’s vessel and tissue sealing product portfolio. The company also successfully completed all European requirements imposed on the product in order to CE Mark the product. According to the company, they will start marketing the product later in this quarter in the U.S. and Europe.
In a recent communication AMAG Pharmaceuticals Inc., stated that the FDA recently denied their request to utilize their Feraheme drug on a broader scale; a medication used to treat iron deficiency anemia. According to the FDA, concerns have arisen regarding the safety of the product, and they have requested that the company compile and provide additional trial data to back up their claims. So far the industry has reported that the denial has resulted in a 15 percent drop in shares for the company.
This week, an FDA advisory panel voted 16-1 in favor of Northera, a drug manufactured by Chelsea Therapeutics and used to treat Neurogenic Orthostatic Hypotension NOH - a rare form of low blood pressure. The disease is associated with neurological disorders including Parkinson’s disease and affects the patient only when they are in a standing position.
The biopharmaceutical company Amarin Corporation, announced this week that the Division of Metabolism and Endocrinology Products (DMEP), a sub department of the FDA, notified the company that their decision to reconsider the ANCHOR clinical trial Special Protocol Assessment (SPA) had been delayed. The company entered an application request for reconsideration of the DMEP’s October 2013 decision to rescind the agreement.
Alexion Pharmaceuticals announced that the FDA granted the drug Soliris® (eculizumab) with an orphan drug designation. This designation is given to drugs that are developed to treat rare conditions that affect fewer than 200,000 individuals.
According to recent research conducted by GBI Research, the market for Monoclonal Antibodies (mAbs), designed to treat gastric and esophageal cancers, is expected to expand by 2019. mAbs are used to treat certain cancers. Herceptin has been approved by the FDA to treat breast cancer. While the drug is primarily marketed for and targeted towards the breast cancer market, in 2010 the FDA also approved Herceptin to treat gastric and esophageal cancer - making it the only mAbs approved for both cancers.
January 16, 2014 - The NIH stated that a team of scientists from the NIH and the University of North Carolina have developed an effective toxin which can be used to control the spread of HIV infected cells in a human host. The study was conducted using lab mice. The toxin, labeled 3B3-PE38, was initially developed n 1998 and genetically altered for the study.
The FDA has made an application approval for a drug to treat Refractory Indolent Non-Hodgkin's Lymphoma. The announcement was made by Gilead Sciences on January 13, 2014. The FDA will be reviewing Gilead Sciences’ Idelalisib drug, an oral inhibitor of phosphoinositide 3-kinase (PI3K delta) designed to be used as a treatment for Indolent Non-Hodgkin's Lymphoma (iNHL). According to the documentation, the FDA has issued a review date for September 11, 2014 under the Prescription Drug User Fee Act.