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Archives for January 2008

A Filtration Collaboration: Delcath and Aethlon to Expand Cancer Treatment Options

Aethlon Medical and Delcath Systems have agreed to jointly research and develop a new filtration cartridge for use in Delcath’s percutaneous hepatic perfusion (”PHP”) system.

PHP is a technology designed to isolate and deliver high doses of anti-cancer agents to specific organs, while minimizing harmful drug exposure in the rest of the body.

One of the central problems in using chemotherapy to treat cancer is its harmful effect on organ health. Lower dosages of the drug are often used to limit side effects, which may diminish the benefit of the therapy. Delcath has developed a drug delivery system that isolates the liver from the circulatory system. It allows chemotherapy agents to be administered to the liver and filters those agents from the blood before returning it to general circulation.

The collaboration will allow Delcath to utilize Aethlon’s filtration expertise. Under the terms of the agreement,

31 January 2008 | Blog, news1 | 2 Comments

Healthcare Reform 2008 - Evolution or Revolution?

Healthcare Forum 2008

30 January 2008 | ad1 | No Comments

Healthcare Reform 2008 - Evolution or Revolution?

Event to be hosted by the Executive Council

Tuesday, February 12, 2008
8:00AM - 11:00 AM

Harvard Club of New York
27 West 44th Street
New York, NY 10019

It now appears certain that healthcare reform will be high on the political agenda next year. The upcoming Presidential and Congressional elections promise to focus public and business leaders’ attention on proposals to heal our ailing healthcare system. This requires more than force of will or mere innovation. Everyone would agree that the current system is unsustainable. What is the best way to change the system? Full market-based? Governmental-run system?

For New York, the stakes could not be higher.

At this private forum, you will get answers to key issues:

30 January 2008 | Member Spotlight | No Comments

BioSphere to Market Microspheres in China

Company eyes large opportunity in treating liver cancer

Rockland, MA-based BioSphere Medical reported this week that the Medical Device Department of the People’s Republic of China approved BioSphere’s Embosphere Microspheres for clinical use in treating vascular embolizations, arteriovenous malformations, hypervascularized tumors, and symptomatic uterine fibroids.

Approximately 200 million Chinese have health coverage, creating a market opportunity close to that found in the U.S. Notably, the opportunity for hepatocellular carcinoma (HCC or primary liver cancer) treatment represents roughly half of the total worldwide, with an annual incidence of approximately 350,000.

The high occurrence of HCC in China is attributed to the high historical prevalence of the hepatitis B and C viruses. These viruses damage the liver and can contribute in time to the development of primary liver cancer. BioSphere’s technology can be used by physicians to embolize the resulting tumors.

Embolotherapy works by reducing blood flow

30 January 2008 | Blog, news2 | No Comments

[Video Profile] Interview with John Seaberg, CEO of NeoChord

This interview with John Seaberg, CEO of NeoChord, is the first of many filmed earlier this month at the OMP Finance Forum.

NeoChord aims to significantly improve the surgical repair of mitral valve regurgitation through the use of minimally invasive surgical techniques for the implantation of artificial chordae tendineae. NeoChords’s new technology eliminates the need for a sternotomy (opening of the chest cavity via sawing open the sternum) and cardio pulmonary bypass (heart-lung machine).

This less invasive approach will allow current surgical patients to be treated less traumatically and with fewer complications than is currently the norm. It will also allow mitral regurgitation patients to be treated earlier in the course of their disease which will eliminate or retard the progression of mitral regurgitation into congestive heart failure.

The market for less invasive techniques for mitral valve repair has been estimated at over

29 January 2008 | Blog, Executive Summary, Member Spotlight, Video, news2 | 3 Comments

Bad Tasting Medicine a Thing of the Past?

While some might consider forcing down terrible-tasting cough syrup a right of passage, this childhood trauma may soon go the way of chicken pox.

Aversive taste is a leading factor in patient noncompliance with many prescribed liquid formulations of antibiotics, resulting in lack of efficacy and emergence of resistant infections. Many potentially useful formulations of medicines and OTC products in liquid, chewable, or rapid-dissolving forms are precluded by their bitter or aversive taste.

Redpoint Bio
is a biotechnology company developing better tasting products for the pharmaceutical, food and beverage industries. The company uses taste blockers and enhancers to make medicines more palatable, and to make prepared foods and beverages better tasting and more healthful.

Taste is the primary sense that humans use to evaluate what they are going to eat and drink. There are five basic taste qualities, three of which – sweet, savory,

28 January 2008 | Blog, news1 | No Comments

Breast Cancer Screening Co-Pay Could Hurt Insurers’ Bottom Line

A new study in The New England Journal of Medicine found that a modest insurance co-pay was enough to deter many older women from getting potentially life-saving mammograms.

The study examined 366,475 women between the ages of 65 to 69 enrolled at 174 Medicare managed-care plans. Screening rates were 8.3% lower for women whose plans required a co-payment (versus women whose plans covered the entire cost). Co-pays averaged $20, but ranged from $12.50 to $35. During the four-year study, the number of plans requiring co-pays rose 10%, from three plans in 2001 to 21 in 2004.

Mammography has been shown to reduce the rate of mortality by as much as 20 – 40%. Because it is cheaper to treat breast cancer when caught early, it may be cost-effective for insurers to exempt elderly patients from mammogram co-pays. The American Cancer Society estimates that

25 January 2008 | Blog, news2 | No Comments

Luminex to Streamline Tyson’s Food Safety Network

As Tyson Food’s Richard Bond led an initiative to cut costs and improve earnings, he no doubt eyed the costly but necessary food safety and animal health division.

The company announced yesterday that it will collaborate with Luminex to create faster, more accurate and cost-effective food safety and animal health tests.

Tyson’s Food Safety Network comprises 17 laboratories spread across the country. This includes a 25,000-square-foot food testing and research laboratory in Springdale, Arkansas.

The first initiative is the development of an avian flock health monitoring panel. Future research and development projects will be focused on food safety and quality, and additional animal health diagnostic panels. Luminex will leverage its xMAP technology to develop tests that screen for pathogens and other microbes more efficiently and accurately.

xMAP enables multiple tests to be run simultaneously on one sample. The system uses color-coded beads known as microspheres

24 January 2008 | Blog, news2 | No Comments

NovaDel NDA: Longs May Finally Get a Good Night’s Sleep

The FDA has accepted Flemington, NJ-based NovaDel Pharma’s New Drug Application for ZolpiMist. ZolpiMist is an oral spray for the short-term treatment of insomnia. The company anticipates the FDA will complete its review by the end of the year consistent with PDUFA guidelines.

Following NovaDel’s regulatory strategy, the company submitted the NDA using the 505(b) (2) path. This allows a NovaDel to rely upon the FDA’s findings of safety and efficacy for a previously approved drug, shortening the development time.

NovaDel’s NDA is based on data from two randomized, open-label, dose-ranging studies comparing ZolpiMist with Ambien tablets in young and elderly healthy volunteers. Both studies compared the pharmacokinetics and safety of comparable doses of zolpidem administered as an oral spray versus tablets. The speed of drug absorption and level of sedation were also assessed in these studies. The results demonstrated bioequivalence between ZolpiMist

23 January 2008 | Blog, Member Spotlight, news1 | 1 Comment

Nanomaterial Coatings Help Drugs Bypass Bodily Defenses

A new study published in the January issue of ACS Nano offers insight into cutting edge world of drug delivery research. In the study, UCLA and Northwestern University researchers used nanoscale polymer film coatings to circumvent typical bodily defenses while delivering a drug payload.

An inert nanoscale polymer film (‘orders of magnitude thinner’ than conventional drug deliver coatings, say researchers) was used to coat sandwich-like chips which held the anti-inflammatory drug Dexamethasone.

The film was designed to ‘hide’ the chips from the body’s natural defenses.

In experiments with lab mice, coated chips suppressed the expression of cytokines, proteins released by the body during an immune system response. Uncoated implants generated an inflammatory response in the tissue surrounding the implant.

The nanomaterial coating shielded the implant from bodily defenses so effectively that tissue in the mice with no implants was virtually identical to that of mice

22 January 2008 | Blog, news2 | No Comments

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