ARTICLES BY CASSANDRA LEGER
-
TCGA Study Reveals Potential Target Area For Bladder Cancer Treatment1/31/2014
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.
-
FDA Approves Covidien's LigaSure Maryland Jaw Device1/24/2014
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.
-
AMAG's Shares Drop As FDA Rejects Feraheme For Wider Use1/24/2014
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.
-
FDA Advisory Panel Votes For Northera For A Second Time1/22/2014
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 FDA Granted Soliris With An Orphan Drug Designation1/22/2014
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.
-
FDA Approves Application Review For Refractory Indolent Non-Hodgkin's Lymphoma1/16/2014
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.
-
Lilly Buys Back CGRP Antibody Rights1/14/2014
January 13, 2014 - Eli Lilly & Company announced a successful acquisition of the entirety of Arteaus Therapeutics’ developmental rights of the Calcitonin Gene-related Peptide antibody, commonly referred to as the CGRP antibody. CGRP, a sensory neuropeptide, =has vascular and pro-inflammatory effects. As a result, the CGRP antibody is currently being studied as a viable treatment for aggressive and/ or reoccurring migraines.
-
J&J Petitions FDA To Regulate Naming Of Biosimilars1/13/2014
Johnson & Johnson addressed the FDA with a petition requesting that the U.S. administration regulate the labeling of biosimilars; specifically those that bear names reminiscent of their reference product but are not indistinctly the same. According to the petition, Johnson & Johnson states that distinguished versions of the names are necessary to ensure patient safety and maintain proper pharmacovigilance.
-
FDA To Approve Leukemia Drug For The Second Time1/10/2014
This week the FDA announced it was approving the use of Iclusig to treat leukemia. Iclusig, a product of Ariad Pharmaceuticals, Inc., was previously approved by the FDA in 2012 to treat chronic myeloid leukemia and Philadelphia chromosome positive acute lymphoblastic leukemia. However, the treatment was limited by the FDA and designated to only be used in patients who did not respond to any other treatment being given to them at the time. Iclusig became a last resort for leukemia sufferers until October 31, 2013, when the FDA asked the manufacturer of the drug to suspend marketing and sales of Iclusig.
-
Taiwanese Company Working To Get Approval For Avian Flu Vaccine In China1/6/2014
Adimmune Corp, a Taiwanese company, is working to gain drug approval and have marketing certification in China for a new trivalent vaccine against avian flu. They plan to do so by mid-summer 2014, thereby making them the first company in Taiwan to do so if they succeed.