AstraZeneca submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) seeking marketing clearance for its investigational oral direct thrombin inhibitor "ximelagatran" (Exanta) for the prevention of venous thromboembolism (VTE) in patients undergoing knee- replacement surgery; for the prevention of stroke and other thromboembolic complications associated with atrial fibrillation (AF); and for the long-term secondary prevention of VTE after standard treatment for an episode of acute VTE.
DNA testing may help simplify clinical trials
GlaxoSmithKline's head of genetics said that some 90 per cent of drugs are only effective in about 30 per cent to 50 per cent of the people taking them. "Yet it has been an open secret within the drugs industry that most drugs do not work for most patients." "A secret that has now been publicly aired for the first time." Roses, who has championed the emerging area of pharmacogenomics, which would use patients' DNA to ascertain who would respond to a drug and who would not, notes that such testing would help better tailor disease therapies. Such an approach could mean drugs are targeted more safely and effectively. Expensive Phase III clinical trials could be simplified if those who would respond to the drug are identified.
UK acts against misleading advertising
The Medicines and Healthcare Products Regulatory Agency said it would name companies it finds guilty of misleading advertising. The agency said it had decided to publish on its Web site details of complaints it receives, including the product and company concerned, and the outcome of investigations. The move follows a complaint by the Drug and Therapeutics Bulletin that the agency was failing to control an epidemic of misleading advertising to healthcare professionals. The agency can order companies to withdraw misleading adverts and issue corrective statements. Failure to cooperate could result in criminal sanctions.
Medical Associations issue statement guiding doctors on use of diabetic drugs (TZDs)
In response to a series of reports linking popular diabetes medications to congestive heart failure, the American Heart Association and the American Diabetes Association have issued recommendations to guide physicians and patients in the use of glucose-lowering agents known as thiazolidinediones (TZDs).
Diabetes is a major risk factor for heart disease. TZD agents rosiglitazone maleate and pioglitazone hydrochloride help doctors manage patients' glucose (blood sugar) levels and may even modify other heart disease risk factors such as high blood pressure, high cholesterol and inflammation. There is now widespread use of TZDs in a broad group of patients with type 2 diabetes. At the same time there have been reports of congestive heart failure associated with their use. In some people, the drugs are associated with fluid retention known as edema, especially swelling of the feet. Edema may also be a hallmark of congestive heart failure.
US patent for a dry film coating powder
An edible dry-powder formulation of a film coating for pharmaceuticals and confectionaries using gum acacia as a low-cost film former is provided. A cellulosic polymer such as hydroxypropyl methylcellulose is used in addition to the gum acacia. A plasticizer such as propylene glycol is also added. The resulting formulation is a dry, free flowing powder that can be put into solution and applied to a tablet or other substrate without an extended waiting period. The resulting film coating is clear, shiny, durable and extremely economical. Because the formulation is a dry powder, it has along shelf life and low shipping costs. US patent no 6660302 was issued on December 9, 2003.
Pharmaceutical industry facing challenges
The pharmaceutical industry is expected to launch just 50 new drugs per year between 2002 and 2006 compared with an average of 59 per year between 1998 and 2002. Moreover, generic competition will threaten one-fifth of annual sales for drug makers in the U.S. alone. To combat this, the drug industry must overcome two major challenges -- controlling costs and improving the productivity of its R&D.
Less than 30 per cent of drugs launched last year were first or second in their class. Roughly 40 per cent of R&D spending by Big Pharma is now on 'line extensions' -- improving existing drugs, not creating entirely new ones." While some drug makers are licensing products from biotechnology companies and others such as Wyeth and GlaxoSmithKline are trying to improve on their in-house R&D.
Arthritis Foundation announces top 10 arthritis research advances of 2003
New treatments for arthritis and related diseases -- including the first synthetic hormone drugs for osteoporosis and more durable joint replacement materials -- are among the top 10 arthritis research advances of 2003, according to the Arthritis Foundation. Breakthrough discoveries also include a marker for rheumatoid arthritis
Following are summaries of the top 10 arthritis research advances of 2003.
1. Protein found to be marker of RA years before symptoms appear
A simple routine blood test may predict future development of RA. Such a test could improve early diagnosis and lead to very early treatment and prevention of joint damage.
2. Synthetic HRT prevents bone loss without risk of cancer
In 2003, researchers unraveled the mystery of how the synthetic hormone, estren, works. It has the potential for developing a safer hormone therapy to prevent osteoporosis in men and women.
3. Sturdier joint replacements challenge long-held belief of surgery as last resort
Young adults and baby boomers with arthritis who suffer from severe pain and disability may benefit from earlier total joint replacement surgery.
4. Lupus gene patterns activated by interferon identified in adults and children
A distinctive genetic profile present in lupus may be valuable in both diagnosing and predicting severity of the disease. Interferon appears to play an important role in activating the major genes involved in lupus, and may be an important target for lupus treatment.
5. First FDA-approved oral scleroderma drug reverses life-threatening complications
This new oral treatment represents an exciting new era for physicians and patients dealing with this devastating disease, and offers people with scleroderma hope for longer and fuller lives.
6. Clarification of how a genetic defect may lead to childhood arthritis
Increased understanding of the genetic basis of childhood arthritis diseases could guide the development of new treatments and possible prevention of the diseases in the future.
7. Prevention of heart disease complications in RA
Premature cardiovascular disease is a major, life-threatening complication of RA. Treatment with statins may have an important role in controlling joint inflammation and preventing heart complications.
8. MRI allows earlier detection of OA and prevention of painful symptoms
Assessing changes in cartilage with MRI will make it easier to conduct clinical trials in OA to develop and test new treatments.
9. Individually tailored physical activity programs in people with arthritis.
The sharing of expertise from multiple disciplines will enable doctors and patients to make the best use of existing information about exercise and arthritis to develop individually tailored physical activity regimens.
10. Disparities in joint replacement surgery revealed.
These studies are an important step in expanding our understanding of disparities in healthcare treatment of arthritis and the barriers that keep all persons with arthritis from utilizing the advances in medical care and surgery that can reduce unnecessary pain and disability.
Compiled from WWW by Venkat Appaji Padmanabhuni appajipv@hotmail.com