As part of the agreement, Antares Pharma has acquired intellectual property including multiple patents for prefilled cartridge technology particularly suited to jet injection. This includes reusable injector system technology adapted for use with prefilled cartridges and composite cartridge technology that can overcome the challenges inherent to the high pressures involved in jet injection. The patented technology also takes into account the pharmaceutical requirements for the storage of the injectable drugs. Under the terms of the agreement, Endoscoptic and Antares Pharma will initiate collaborations to bring projects to market. The agreement supports the continued development of needle-free syringe cartridges as the primary containers for pharmaceutical products by combining Endoscoptic''s technology with Antares Pharma''s experience and expertise in designing and manufacturing needle-free injection systems.
Antares Pharma is an established leader in needle-free pharmaceutical delivery systems and currently markets a reusable needle free injection system for the delivery of insulin in the United States and supplies Ferring Pharmaceuticals, in Europe, with devices used for the delivery of human growth hormone. Antares Pharma develops and markets innovative and effective pharmaceutical delivery solutions, including needle-free and mini-needle injector systems, gel technologies and transdermal products.
US Court orders generic paclitaxel (Taxol) off market
The Food and Drug Administration was wrong to approve a generic version of the breast cancer drug Taxol, a federal appeals court said, ordering that the generic drug be pulled from the market. Taxol is one of the most widely used treatments for breast and ovarian cancer and earns manufacturer Bristol-Myers Squibb Co. more than $1 billion in U.S. sales each year. Ivax Corp. of Miami has been selling its generic version of Taxol, called paclitaxel, for just over a yearUnder federal law, the FDA cannot approve generic drugs if there are valid patent claims.
Bristol-Myers Squibb''s patent has expired, but ABI says it has a claim on the drug, too, and says that claim is still in force. The FDA argued that ABI''s patent claim was not filed on time and therefore is not valid. In the last year, the FDA has approved two other generic forms of Taxol. While the court''s action does not directly affect them, the FDA used the same reasoning in approving those applications. Ivax President said it was 30 to 40 percent less than Taxol, which can cost $5,000 to $7,000 per person. "There are thousands and thousands of women suffering from breast and ovarian cancer who need this product and can''t afford the monopoly prices the brand company charges," Flanzraich said.
Taxol was discovered by the taxpayer-funded National Cancer Institute, which licensed the drug to Bristol-Myers. First approved in 1992 as second-line therapy for advanced ovarian or breast cancer, Taxol today is used against AIDS-related Kaposi''s sarcoma and lung cancer as well.
Menopause hormones, dry eyes linked
Hormones taken by millions of women at menopause can increase the risk of dry eye syndrome, which in severe cases can affect vision, a study found. In the study of 25,389 women taking both oestrogen and progesterone faced a 30 percent increased risk. The findings appear in Journal of the American Medical Association. Hormone supplements relieve symptoms such as hot flashes and night sweats that happen when women''s bodies stop making natural oestrogen and progesterone. In addition, they can protect against osteoporosis. But they have also been linked to an increased risk of breast cancer. Dry eye syndrome can be severe and can impair the ability to read, work and drive, but it does not usually cause blindness. Schaumberg said it is unclear how hormones might cause dry eyes, though she noted that oestrogen can inhibit oil-producing glands and might affect a gland in the eyelid that produces an oily substance in tears.
US FDA takes up investigation of Dialyzers made by Baxter
The US FDA is investigating reports of over 50 patient deaths worldwide, including four in the United States, that may have been caused by certain dialyzers made by Baxter Healthcare Corporation, Deerfield, Ill. Baxter voluntarily recalled the dialyzers in mid-October after reports of deaths associated with its product in kidney dialysis patients in Spain, Croatia, Italy, Germany, Taiwan, Colombia and the U.S. Most of the dialysis patients who died experienced shortness of breath, chest tightness, cardiac arrest or stroke symptoms within hours of being dialyzed. FDA has worked closely with Baxter and with regulatory agencies abroad to identify the problems quickly, and protect public health by recalling the dialyzers.
Preliminary tests have led Baxter to conclude that a perfluorohydrocarbon-based performance fluid used in a manufacturing step may have played a role in the deaths of these patients. Confirmatory tests are underway. Baxter reports that it has permanently ceased manufacturing these dialyzers.
Biocapsules: Revolutionizing Insulin Delivery
Insulin therapy generates $3 billion at a global level, of which the United States has a share of approximately $1.25 billion. Insulin has been administered through injections for more than 75 years. Many of the patients take three to four shots a day. This is highly inconvenient and results in low patient compliance.. Pushing the frontiers of drug delivery technology, Tejal Desai, a biomedical engineer at the University of Illinois at Chicago has developed an implantable capsule that releases a steady supply of insulin to the bloodstream of people with diabetes.
Supported by the National Science Foundation (NSF), the biocapsule features two innovations designed to overcome obstacles that were encountered in the past. It functions as a biological process that allows the capsule to continuously produce insulin, rather than use up the limited supply. The capsule is also made of a material designed to overcome the problem of implant rejection. The capsule essentially acts as a bioreactor; it contains insulin-secreting cells that borrow nutrients from the body to keep producing insulin indefinitely. As long as the body produces glucose, the cells will respond with insulin. This is amongst the first successfully implantable micro-scale devices.
Tiny devices made with microchip technology have been researched extensively for implantable medical applications, but biocompatibility has been an ongoing problem. To prevent the capsule from being attacked and destroyed by the immune system, the team developed a silicon membrane covered with tiny uniform pores, each seven nanometers across. The membrane acts as a "microfilter," allowing the secretion of insulin from the capsule but blocking the entrance of antibodies.. The next steps would be testing the capsule for long-term usage and evaluating the ideal dosage level.
Compiled from WWW by Dr. Venkat Appaji Padmanabhunie-mail : appajipv@hotmail.com