Latest Fda Approved Drugs Information Systems

Smoking, pulmonary hypertension, and a decline in lung function are associated with an increased risk of death in people with chronic obstructive pulmonary disease (COPD). Now researchers in Spain have added another potential risk factor: the presence and severity of bronchiectasis. Compared with unaffected patients with COPD, patients with bronchiectasis had more than double the risk of dying than those without, according to a prospective, observational study published online February 8 in the  American Journal of Respiratory and Critical Care Medicine . Miguel Angel Martínez-García, MD, from the Pneumology Service at the University and Polytechnic La Fe Hospital in Valencia, Spain, and colleagues assessed 201 participants with moderate to severe COPD from a consecutive series of outpatients diagnosed at 1 of 2 specialty clinics in Spain. The mean age of participants was 70 years, and 91% were men. A majority (77%) featured radiologic signs of emphysema. Patients were diagn...

Smoking, pulmonary hypertension, and a decline in lung function are associated with an increased risk of death in people with chronic obstructive pulmonary disease (COPD). Now researchers in Spain have added another potential risk factor: the presence and severity of bronchiectasis. Compared with unaffected patients with COPD, patients with bronchiectasis had more than double the risk of dying than those without, according to a prospective, observational study published online February 8 in the  American Journal of Respiratory and Critical Care Medicine . Miguel Angel Martínez-García, MD, from the Pneumology Service at the University and Polytechnic La Fe Hospital in Valencia, Spain, and colleagues assessed 201 participants with moderate to severe COPD from a consecutive series of outpatients diagnosed at 1 of 2 specialty clinics in Spain. The mean age of participants was 70 years, and 91% were men. A majority (77%) featured radiologic signs of emphysema. Patients were diagn...

The US Food and Drug Administration (FDA) today issued a proposal designed to assist companies focused on the development of new treatments for patients in the early stages of Alzheimer's disease (AD). "The scientific community and the FDA believe that it is critical to identify and study patients with very early Alzheimer's disease before there is too much irreversible injury to the brain," Russell Katz, MD, director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, said in a statement announcing the draft proposal. "It is in this population that most researchers believe that new drugs have the best chance of providing meaningful benefit to patients," he added. The  guidance document  outlines the FDA's current thinking about how best to identify and select patients with early AD, or those who are at risk of developing the disease, for enrollment in clinical trials, the FDA explains. The proposal ad...

There is no link between work-related stress and several common cancer types, according to a meta-analysis  published online  February 7 in  BMJ . An international team of researchers, led by Katriina Heikkilä, PhD, from the Finnish Institute of Occupational Health in Helsinki, found that it is unlikely that job stress is a risk factor for colorectal, lung, breast, or prostate cancer, and it is not associated with an overall risk for cancer (hazard ratio [HR], 0.97). The researchers note that approximately 90% of cancers have been linked to environment and lifestyle, but evidence of associations with other factors, including psychosocial ones, is tentative. However, it is possible that one psychosocial factor — stress — plays a role in the development of cancer. The physiological stress response is characterized by the secretion of more hypothalamic and pituitary stress hormones, the researchers explain. These stress biomarkers trigger and maintain chronic i...

New estimates suggest that there were 4.7 million individuals aged 65 years or older with Alzheimer's disease dementia in the US in 2010 and that this number will triple to 13.8 million by 2050. These latest estimates,  published online  February 6 in Neurology , were devised by a team from the Rush Institute for Healthy Aging, Chicago, Illinois. "These are staggering numbers," coauthor Jennifer Weuve, MPH, ScD, commented to  Medscape Medical News . "The ramifications for society and family caregivers in particular are huge." "This is not really a surprise," she added. "It's a bit like climate change. We've known about it for years but we haven't done much to stop it. Our data drum home the message that research into the prevention and treatment of Alzheimer's must be a priority, as well as developing better ways of managing patients with the condition and helping caregivers." A Complicated Task Weuve explained th...

President Barack Obama yesterday renominated Marilyn Tavenner, the acting administrator of the Centers for Medicare & Medicaid Services (CMS), to serve in that post without the caveat of "acting" attached to it. If the Senate approves her nomination, Tavenner will be the first confirmed, full-fledged CMS administrator since Mark McClellan, MD, PhD, stepped down from that position in October 2006, during the George W. Bush administration. Dr. McClellan's successors either were acting administrators or, in the case of Donald Berwick, MD, who was Tavenner's immediate predecessor, a recess appointment. As illustrated by Dr. Berwick's  CMS history , Senate confirmation can be tough to get when one party has enough votes to filibuster and otherwise stymie a nomination by an opposing party's president. That was the case when Obama nominated Dr. Berwick, whom Senate Republicans portrayed as an advocate of healthcare rationing, a characterization denied by t...

The U.S. Food and Drug Administration today approved Pomalyst (pomalidomide) to treat patients with multiple myeloma whose disease progressed after being treated with other cancer drugs. Multiple myeloma is a form of blood cancer that primarily affects older adults and arises from plasma cells in the bone marrow. According to the National Cancer Institute, approximately 21,700 Americans are diagnosed with multiple myeloma and 10,710 die yearly from the disease. Pomalyst is a pill that modulates the body’s immune system to destroy cancerous cells and inhibit their growth. It is intended for patients who have received at least two prior therapies, including lenalidomide and bortezomib, and whose disease did not respond to treatment and progressed within 60 days of the last treatment (relapsed and refractory). For more information please visit:  Pomalyst