IDM Pharma (NASDAQ:IDMI) announced today that the company has submitted an electronic New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Junovan(TM) (mifamurtide for injection), requesting approval for its use in the treatment of newly diagnosed resectable high grade osteosarcoma patients following surgical resection in combination with multiple agent chemotherapy.
In another important milestone, Glivec? (imatinib) has received US regulatory approval to help patients with five distinct and potentially life-threatening disorders, representing the first time that a regulatory authority has ever simultaneously approved one targeted medicine for so many disorders. With today’s decision, and in only five years, Glivec has now been approved in the US for seven diseases, including two solid tumors and five blood disorders with molecular targets known to be inhibited by the drug.
GlaxoSmithKline (NYSE: GSK) and Flamel Technologies (NASDAQ:FLML) announced FDA approval of once-a-day Coreg CR (carvedilol phosphate) extended-release capsules, for the treatment of three cardiovascular conditions: 1. High blood pressure, also known as hypertension. 2. A heart attack that has reduced how well the heart pumps (known medically as post-myocardial infarction left ventricular dysfunction). 3. Mild to severe heart failure.
Eli Lilly and Company has launched a major clinical trial evaluating ALIMTA (pemetrexed for injection) in extensive-stage small cell lung cancer (SCLC), a devastating and rapidly spreading form of lung cancer. This international trial, expected to be the largest ever to be conducted in SCLC(1), will assess the potential clinical benefit of pemetrexed in combination with carboplatin, a commonly-used chemotherapeutic agent, in direct comparison to the current leading treatment option of etoposide in combination with carboplatin.
The link between short sleep duration and obesity: We should recommend more sleep to prevent obesity. Soaring levels of obesity might be linked to children sleeping fewer hours at night than they used to, claims a researcher in the Archives of Disease in Childhood.
Mass vaccination would not be necessary in the event of a large-scale smallpox bioterrorist attack in the United States, according to a study led by researchers at Fred Hutchinson Cancer Research Center that appears online in the International Journal of Infectious Diseases.
A new article reviews the literature of quantitative electroencephalography (QEEG) that documents abnormal brain wave patterns accompanying several medical conditions. The research implies that neurofeedback training may partially or fully normalize these brain wave patterns, and improve the physical and mental functioning of people with these conditions. The article is in the latest issue of Biofeedback.
Children with high blood pressure may be at risk for sleep breathing disorders, according to a small study reported at the American Heart Association’s 60th Annual Fall Conference of the Council for High Blood Pressure Research.
CHIKV infection can cause a debilitating illness, most often characterized by fever, headache, fatigue, nausea, vomiting, muscle pain, rash, and joint pain. The term ?chikungunya? is Swahili for ?that which bends up.?
Women undergoing radiation treatment for breast cancer benefit from moderate intensity, regular aerobic activity, according to a new study. Published in the November 15, 2006 issue of CANCER, a peer-reviewed journal of the American Cancer Society, the study found that exercise improved the oxygen capacity of patients and maintained levels of red blood cells during radiation treatment. In contrast, women who did not exercise experienced significant declines in their oxygen capacity. This is the first study to investigate the effect of exercise during treatment.