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Aspirin And Breast Cancer
Dr Venkat Appaji Padmanabhuni | Tuesday, June 15, 2004, 08:00 Hrs  [IST]

A study published in the Journal of the American Medical Association suggests that women who frequently use aspirin may have a lower risk for hormone-sensitive breast cancer, which is the most common form of the disease. The study compared data on more than 2,800 women, age 59 on average, about half of whom had breast cancer and half of whom didn't. The women who took aspirin at least four times per week had an almost 30 per cent lower risk of developing hormone-sensitive breast cancer compared to women who did not take aspirin. The strongest reductions in risk were in women who took seven or more aspirins per week and in postmenopausal women, who have a higher risk for hormone-sensitive breast cancer. However, the researchers say it is too soon to recommend that women take an aspirin specifically to prevent breast cancer, especially since aspirin use carries other health risks including stomach ulcers and bleeding.

US FDA Warns Breastfeeding Women Against Use of Domperidone To Increase Lactation

In response to reports that women may be using an unapproved drug (in USA), domperidone, to increase milk production (lactation), the Food and Drug Administration (FDA) has warned breastfeeding women not to use this product because of safety concerns. The Agency also is issuing an Import Alert which alerts FDA field personnel to be on the lookout for attempts to import this drug so that it can be detained and refused admission into the US if appropriate.

FDA took these actions because it has become aware that some women who breastfeed and/or pump breast milk are purchasing this drug, domperidone, from compounding pharmacies and from sources in foreign countries to increase breast milk production. Domperidone may increase the secretion of prolactin, a hormone that is needed for lactation. Domperidone is approved in several countries including India to treat certain gastric disorders but it is not approved in any country for enhancing breast milk production in lactating women. It is marketed in India by several companies in different brand names.

There have been several published reports and case studies of cardiac arrhythmias, cardiac arrest, and sudden death in patients receiving an intravenous form of domperidone that has been withdrawn from marketing in a number of countries

ADA Advises Widespread Use Of Statins For Diabetics

The American Diabetes Association (ADA) has published updated clinical practice recommendations covering the treatment of type 2 diabetes. The new guidelines advise the greater use of statins for lipid control in type 2 diabetic patients, offering a further significant market opportunity for these drugs.

Type 2 diabetes is estimated to currently affect 194 million people worldwide and this figure is forecast to grow to 333 million by 2025. Patients suffering from type 2 diabetes are at a greatly increased risk of vascular complications. The ADA recommends the commencement of statin therapy for all type 2 diabetics over 40 years of age with a moderately elevated LDL cholesterol level, with a target reduction of at least 30 per cent. The ACP guidelines advise the use of statins in all type 2 diabetics over the age of 55 or those with elevated cardiovascular risks such as a history of smoking or hypertension.

The First Monthly Oral Pill For Osteoporosis

The osteoporosis market, worth $7 billion in 2003, is dominated by once-weekly bisphosphonates Fosamax (alendronate) from Merck and Actonel (risedronate) from P&G/Aventis. Roche/GSK's novel bisphosphonate Boniva (ibandronate) will likely be the first once monthly formulation to gain approval. Roche has announced the submission of a supplemental new drug application (sNDA) to the US FDA for their once monthly oral formulation of the bisphosphonate Boniva (ibandronate). The drug is likely to be the first product available on the market with this novel dosing regimen. Although there are two well-established weekly bisphosphonates on the market, Fosamax and Actonel, and many physicians consider drugs in this class to have similar efficacy, Boniva still stands to gain a significant share of the market due to its monthly oral dose. Boniva was actually approved by the FDA to prevent and treat osteoporosis in May 2003 in a daily oral dose. However, Roche/GSK stated that they would not make the product available until development of less frequent dosing regimens was complete. The filing of this sNDA is the first fruit of this process. The companies are also thought to be working on a three monthly injectable Boniva regimen, while Novartis [NVS] is developing an annual injection of its bisphosphonate Zometa (zoledronate), currently used in the cancer market.

Therapeutic Monoclonal Antibodies, The Second Wave Of Innovation In Biotechnology Sector

Monoclonal antibodies (mAbs) have come a long way from the time of development to their use in therapeutics. mAbs were quick to win acceptance as research and diagnostic aids, but realising therapeutic potential proved to be much more challenging. By 1990, plagued by costly production problems and disappointing results in initial clinical studies, it appeared that mAbs had failed to live up to their theoretical potential.

However, with genetic engineering advances combined with more focused targets, the potential of therapeutic mAbs has been realised once again. Following the success of recombinant proteins, therapeutic mAbs now represent the second wave of innovation created by the biotechnology industry in the past twenty years. Their specificity against antigen has tremendous clinical value and makes them very attractive therapeutics. The focus, which was once dominated by their use in oncology, has now broadened to encompass additional disease areas. In 1994, the first therapeutic mAb was launched in Europe and since then, nine further mAbs have become commercially available.

Globally, there are 17 FDA approved therapeutic mAbs so far. Of the estimated 370 biotechnology-based drugs in development in 2000, approximately 70 were mAbs, second only to therapeutic vaccines. There are currently 132 mAb products in development.

Frost & Sullivan estimates that global therapeutic mAb market in 2003 was $7.6 billion. The best seller is Johnson & Johnson/Schering-Plough's Remicade (Rheumatoid Arthritis), with sales worth $1.6 billion in 2002. With recent FDA approvals of Erbitux (colorectal cancer; Imclone Systems) and Avastin (colorectal cancer, Genentech), oncology will remain the driving income earner with forecast sales of approximately $7 billion in 2008. Arthritis, immune and inflammatory disorders indication will be the next largest income earners, with sales reaching over $6 billion by 2008.

Breath Analyzer To Detect Early Stages Of Diabetes

John Plodinec, the director of MSU's Diagnostic Instrumentation and Analysis Laboratory, and Chuji Wang, an assistant research professor, worked on the idea together and are seeking a patent. The idea is based on the principle that acetone in the breath is a good indicator of diabetis. Continuous Wave Cavity Ring-Down Spectroscopy, which uses light rays to detect contaminates in the breath was developed by Princeton University and is used to find a wide range of disease indicators, gaseous and environmental pollutants. Wang, was able to demonstrate the feasibility of the breath test. "The main advantage is a fast response and it's noninvasive," said Wang.

The researchers achieved proof of concept, designed a prototype early this year and applied for a patent with the US Patent Office. The body of a diabetic either doesn't make enough insulin or can't use the insulin it produces very well. Type 1 diabetes usually appears in children and young adults with Type 2 diabetes usually appears after age 40.

Counterfeit Medicines On The Rise

The World Health Organisation (WHO) estimates that up to 10 per cent of medicines worldwide may be counterfeit, costing the pharmaceutical industry about $2 billon annually. The range of counterfeit products includes; antibiotics, hormones, analgesics, steroids, antihistamines, antimalarial and the so-called 'lifestyle' drugs. It is often considered a problem of the developing world, where the percentage of counterfeit medicines can be as high as 40 per cent, it is also a blight on more sophisticated markets. In the US, the FDA reported an increase of about six per year from 1997 to 2000 to more than 20 in 2001 and 2002.

The recent cases of counterfeit medicines discovered in the US supply chain include: Lipitor, Neupogen, OxyContin, Procrit, Serostim and Zyprexa. In the UK there have been a few cases of counterfeit product, however, over 100 cases of fraudulent pharmaceutical product supply are investigated every year by the MHRA enforcement division. There is a significant health risk to patients from fraudulent products, particularly counterfeits. Counterfeit drugs often contain harmful products, a different active, to be lacking an active ingredient or to contain less active than required for therapeutic effect.

US Patent For Nasal Delivery Of Apomorphine

A US patent on "Nasal delivery of apomorphine" was awarded to Dr Achari and others in May 2004. The invention provides for a method of treating impotence and male erectile dysfunction in a human in need of such treatment including administering to a nasal membrane of the human an effective amount of a nasally administered pharmaceutical composition including a therapeutically effective amount of a dopamine receptor agonist dispersed in a buffer to maintain its pH, a pharmaceutically acceptable thickening agent and a humectant, wherein the nasally administered pharmaceutical composition does not cause substantial intolerable adverse side effects when administered to the human.

US Patent For Fast Dissolving Tablet

The invention relates to processes for the preparation of tablets which dissolve rapidly in the mouth and provide an excellent mouthfeel. The tablets of the invention comprise a compound which melts at about 37oC or lower, have a low hardness, high stability and generally comprise few insoluble disintegrants which may cause a gritty or chalky sensation in the mouth. Convenient and economically feasible processes by which the tablets of the invention may be produced are also provided. The invention advantageously provides compositions and methods for preparing a fast dissolving tablet of low hardness but good physical stability that can be made at very low compression force. The invention further provides a method of producing a tablet composition. The method comprises combining an active agent (also termed "active ingredient" or "active") with a fast dissolving granulation. The fast dissolving granulation comprises a low melting point compound and a water soluble excipient.

Immune Therapy Stops Diabetes in Mouse

The study suggests it may be possible to retrain a faulty immune system, stopping it from ravaging the pancreas and causing type-1 or juvenile diabetes. Writing in the Journal of Experimental Medicine, Kristin Tarbell and colleagues at Rockefeller University in New York said they used immune system cells called dendritic cells to stimulate production of suppressor T-cells. These T-cells turn off the body's faulty immune response. In the case of the mice, they stopped the destruction of their pancreatic islet cells that causes type-1 diabetes. Type-1 or juvenile diabetes is an autoimmune disease, caused when immune cells for unknown reasons destroy healthy tissue. In diabetes, they kill off the cells in the pancreas that make insulin.

Compiled from WWW by Venkat Appaji Padmanabhuni appajipv@hotmail.com

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