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Category Archives: Drug Studies

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Drugs Disapproved by the FDA Deserve Attention

Posted in Drug Studies, FDA Regulation, Public Health

Recently, Reuters reported that “Drug companies generally don’t disclose all the reasons new medicines fail to win U.S. marketing approval, even though regulators often reject treatments over concerns about safety or effectiveness”. Reporter Lisa Rapaport quotes Dr. Peter Lurie, FDA associate commissioner for public health strategy and analysis, saying “‘Only a minority of the press… Continue Reading

FDA: Xarelto not to be approved for acute coronary syndrome

Posted in Drug Studies, FDA Regulation, Public Health

Yesterday (1/16/2014) Reuters reported that an FDA advisory panel rejected a call by Johnson and Johnson to approve their anticoagulant Xarelto (rivaroxaban) for acute coronary syndrome by a vote of 10-0 with one abstention. While Xarelto “is already used to treat and prevent deep vein thrombosis and pulmonary embolisms and to reduce the risk of… Continue Reading

New Gene Therapy May Help Parkinson’s Patients

Posted in Drug Studies, Public Health

On Thursday, January 9th 2014, MedlinePlus reported that gene therapy may be helpful to patients suffering from advanced-stage Parkinson’s disease, as demonstrated by new research. According to the researchers, this therapy, “called ProSavin, works by reprogramming brain cells to produce dopamine, the chemical essential for controlling movement”. (MedlinePlus) This research comes from an English company,… Continue Reading

New Cancer Drug (Bavituximab – Peregrine Pharmaceuticals) Gains FDA Fast Track Designation

Posted in Drug Studies, Public Health

In recent pharmaceutical news, a new cancer drug from Peregrine Pharmaceuticals, Inc. called Bavituximab has earned Fast Track designation by the US Food and Drug Administration, The Wall Street Journal reports. “The FDA Fast Track Development Program is a designation of the United States Food and Drug Administration (FDA) that accelerates the approval of investigational… Continue Reading

NIH: “Gene-silencing study finds new targets for Parkinson’s disease”

Posted in Drug Studies, Public Health

Recently, National Institutes of Health reports that it has possibly discovered certain genes that can be targeted for the treatment of Parkinson’s disease.  Parkinson’s is a disorder of the central nervous system (which includes the brain and brain stem).  Early signs of the disease are shaking and impaired movement, while later signs may include problems… Continue Reading

2013 – “FDA lifts constraints on Glaxo diabetes drug Avandia”

Posted in Drug Studies, FDA Regulation

A recent article by Bill Berkrot and Ransdell Pierson (published in Reuters) reports on restrictions being lifted from the use of the drug Avandia.  Avandia is a diabetes drug made by the company GlaxoSmithKline that was thought to increase the risk for heart attacks for people using the drug.  The U.S. Food and Drug Administration… Continue Reading

2013 – New Avenues in Malaria Research Explored

Posted in Drug Studies

Malaria is an infectious disease that affects millions of people throughout the world every year.  Most reported cases come from the Sub-Saharan Africa and Asia.  Thousands of people die each year from this disease, and people living in poor countries are at the highest risk.  Parasites from the genus Plasmodium use the biting of mosquitoes… Continue Reading

New Cholesterol Research Focused on MicroRNA

Posted in Drug Studies

Recently, a report published on the Director’s Blog at the National Institutes of Health website discussed new microRNA research on cholesterol.  Cardiovascular disease is one of the most common medical issues today, and cardiovascular health is heavily influenced by cholesterol levels.  There are two types of cholesterol, high-density lipoprotein (HDL) also known as “good” cholesterol,… Continue Reading

2013 – Scripps/Cornell Team Advance HIV Researsch

Posted in Drug Studies

Human immunodeficiency virus (HIV) infects more than 34 million people worldwide.  HIV is a virus that causes acquired immunodeficiency syndrome (AIDS), a condition, which does not allow the immune system to fight off other lethal infections.  HIV. The immune system functions by recognizing proteins on the surface of viruses and bacteria.  HIV is unique in… Continue Reading

Research Shows: Presence of Bacteria in the Gut are Important in Combating Cancer

Posted in Drug Studies

Published Thursday, scientists at the National Cancer Institute wrote an article called “NIH Mouse Study Finds Gut Microorganisms May Determine Cancer Treatment Outcomes”.  The National Cancer Institute believes they may have found a connection between the presence of certain organisms living in the human gut and the success of cancer therapy.  Mice that had cancerous… Continue Reading

FDA approves new cancer drug Crizotinib

Posted in Drug Studies, Public Health

In an article published from the Oncology Report Digital Network by Elizabeth Mechcatie, titled “FDA Grants Full Approval to Crizotinib for NSCLC Indication”, the Food and Drug Administration announced that a new drug was approved for the treatment of small cell lung cancer.  Crizotinib is a kinase inhibitor that works by blocking the actions of… Continue Reading

Reuters: Curis Places Testing of New Cancer Drug On Hold

Posted in Drug Studies

Last Wednesday (11/6/2013), Reuters reported that the approval of a new cancer drug by Curis Inc. has stalled after a patient died while taking the drug. Curis Inc. is a company that develops many new drugs used for in cancer treatment.  In collaboration with other major drug companies, Curis created Erivedge, the only medication for… Continue Reading

New Cancer Drug Ramucirumab (Eli Lilly & Co.) Prioritized by FDA

Posted in Drug Studies

Headquartered in Indianapolis, Indiana, Eli Lilly and Company is a pharmaceutical company with offices all over the world.  Recently, the company developed a single-agent treatment for gastric cancer; a drug called Ramucirumab.  Ramucirumab is used if cancer continues to progress after initial chemotherapy.  And according to a report published 10-24-2013 by PharmaceuticalBusinessReview.com, the company recently… Continue Reading

FDA won’t say which drugs on the market were approved based on fraudulent research

Posted in Drug Studies, FDA Regulation

This shows that the FDA is more interested in protecting pharmaceutical companies than patients.  Note how Woodcock doesn’t want to force new trials because that requires human experimentation, which has risk.  A smarter regulator would realize that the risks increase in proportion to the size of the user base of the drug.  And allowing any… Continue Reading

New study shows risk of weight gain for users of antipsychotic drugs

Posted in Drug Studies

More evidence that certain drugs can cause diabetes… Young children and adolescents who take the newest generation of antipsychotic medications risk rapid weight gain and metabolic changes that could lead to diabetes, hypertension and other illnesses, according to the biggest study yet of first-time users of the drugs. The study, to be published Wednesday in… Continue Reading