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Carter Sinclair News: Shanghai Biolaxy announced the Chinese State Food & Drug Administration (SFDA) has approved the investigational new drug application (IND) for its oral insulin project (Nodlin), an innovative insulin formulation to treat diabetes. This IND approval allows Biolaxy to initiate its first phase I clinical study.

Carter Sinclair News: Diabetes is a disorder characteristic of high blood glucose and poor metabolism. The complications of diabetes often result in severe micro- and macro-vascular diseases, loss of vision, kidney failure, and amputation. Insulin, as an effective diabetic treatment, can slow down diabetic disease progression. However, insulin is given by multiple daily injections at present, which significantly hinders its use.

Oral drug administration is a preferred route. However, the gastrointestinal (GI) tract is designed to digest nutrients like proteins and presents significant challenges for oral insulin including enzyme degradation and poor absorption. Currently, there is no approved oral insulin product despite intensive research in this field.

Nodlin is developed with NOD technology, a patented bio-adhesive nano-particle oral delivery technology, to overcome the barriers of oral insulin.

“IND approval is a significant milestone achievement for Biolaxy,” quoted from William Lee, CEO. “We have experienced long delay in the approval process due to regulatory uncertainties, but we are very happy now Biolaxy is back on track in full speed to develop urgently needed drugs for the patients.”

About Diabetes and Insulin Treatment

Diabetes has reached epidemic stage. It is estimated that there are 30-40 million diabetic patients in China with 1.2 million new cases each year. Insulin is a key diabetic treatment with worldwide market value close to $10 billion. Diabetic patients have to endure multiple daily injections for life and patients often are reluctant to use insulin despite the clinical proven benefits of early insulin treatment. Currently, insulin treatment in China particularly is under used.

Shanghai Biolaxy is a development stage biotech company and emerging leader in innovative delivery for biopharmaceuticals. Biolaxy was established in 2005 and is a wholly owned subsidiary of NOD Pharmaceuticals. Biolaxy uses patented platform technology, nano-particle oral delivery or NOD technology, to develop oral formulations for biopharmaceuticals, including insulin, exenatide, interferon, human growth hormone and more.

Carter Sinclair Org is non-profit organization that helps monitor health status, inform and educate people about health issues. Research for new approach and modern solutions to health problems. For more information please visit www.cartersinclair.org.  Email at info@cartersinclair.org

Carter Sinclair Org is non-profit organization that helps monitor health status, inform and educate people about health issues. Research for new approach and modern solutions to health problems. For more information please visit www.cartersinclair.org. Email at info@cartersinclair.org

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Terra med Alliance News: The drug Sprycel, approved for use by the U.S. Food and Drug Administration in patients with chronic myeloid leukemia, significantly inhibited the growth and invasiveness of ovarian cancer cells and also promoted their death, a study by researchers with UCLA’s Jonsson Comprehensive Cancer Center found.

Terra med Alliance News: The drug, when paired with a chemotherapy regimen, was even more effective in fighting ovarian cancer in cell lines in which signaling of the Src family kinases, associated with the deadly disease, is activated.

The study appears in the Nov. 10, 2009 edition of the British Medical Journal.

Ovarian cancer, which will strike 21,600 women this year and kill 15,500, causes more deaths than any other cancer of the female reproductive system. Few effective therapies for ovarian cancer exist, so it would be advantageous for patients if a new drug could be found that fights the cancer, said Gottfried Konecny, an assistant professor of hematology/oncology, a Jonsson Cancer Center researcher and first author of the study.

“I think Sprycel could be a potential additional drug for treating patients with Src dependent ovarian cancer,” Konecny said. “It is important to remember that this work is only on cancer cell lines, but it is significant enough that it should be used to justify clinical trials to confirm that women with this type of ovarian cancer could benefit.”

Recent gene expression studies have shown that about one-third of women have ovarian cancers with activated Src pathways, so the drug could potentially help 7,000 ovarian cancer patients every year.

In this study, the UCLA team tested the drug against 34 ovarian cancer cell lines and they conducted genetic analysis on all cell lines. Through these analyses, the researchers were able to identify genes that predict response to Sprycel. If the work is confirmed in human studies, it may be possible to test patients for Src activation and select those who would respond prior to treatment, personalizing their care.

“We were able to identify markers in the pre-clinical setting that would allow us to predict response to Sprycel,” Konecny said. “These may help us in future clinical trials in selecting patients for studies of the drug.”

Sprycel is what is known as a “dirty” kinase inhibitor, meaning it inhibits more than one pathway. Konecny said it also inhibits the focal adhesion kinase and ephrin receptor, also associated with ovarian cancer.

The next step, Konecny said, would be to test the drug on women with ovarian cancer in a clinical trial. The tissue of responders would then be analyzed to determine if the Src and other pathways were activated. If that is confirmed, it would further prove that Sprycel could be used to fight ovarian cancer. In studies, women would be screened before entering a trial and only those with Src dependent cancers could be enrolled to provide further evidence, Konecny said, much like the studies of the molecularly targeted breast cancer drug Herceptin enrolled only women who had HER-2 positive disease.

“Herceptin is different because we knew in advance that the only worked in women with HER-2 amplification,” he said. “In this case, we don’t clearly know that yet. The data reassure us that the drug works where the targets are over-expressed but we need more testing to confirm this.”

The tests combining the drug with chemotherapy are significant because chemotherapy currently is the first line treatment for ovarian cancer patients following surgery. Because Sprycel proved to have a synergistic effect when combined with chemotherapy — both made the other work better — it may be possible to add the targeted therapy as a first line treatment if its efficacy is confirmed in future studies, adding a new tool to an oncologist’s arsenal. Adapted from materials provided by University of California – Los Angeles, via EurekAlert!, a service of AAAS.

Terra med Alliance is a non-profit organization in the battle against leukemia  helps  children living with cancer and their families. Our goal is to make sure children battling cancer know they are not alone. For more information please visit www.terramedalliance.org.  Email at contact@terramedalliance.org

Terra med Alliance is a non-profit organization in the battle against leukemia helps children living with cancer and their families. Our goal is to make sure children battling cancer know they are not alone. For more information please visit www.terramedalliance.org. Email at contact@terramedalliance.org

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Product Description
This digital document is an article from Skin & Allergy News, published by International Medical News Group on August 1, 2002. The length of the article is 657 words. The page length shown above is based on a typical 300-word page. The article is delivered in HTML format and is available in your Amazon.com Digital Locker immediately after purchase. You can view it with any web browser.

Citation Details
Title: PhRMA code tightens limits on gift giving. (Hailed by consumer, Medical Groups).(Pharmaceutical Research and Manufacturers of America)
Author: Diana Mahoney
Publication: Skin & Allergy News (Magazine/Journal)
Date: August 1, 2002
Publisher: International Medical News Group
Volume: 33 Issue: 8 Page: 46(1)

Distributed by Thomson Gale
PhRMA code tightens limits on gift giving. : An article from: Skin & Allergy News

Categories : Trials
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Product Description
This digital document is an article from Skin & Allergy News, published by International Medical News Group on August 1, 2002. The length of the article is 657 words. The page length shown above is based on a typical 300-word page. The article is delivered in HTML format and is available in your Amazon.com Digital Locker immediately after purchase. You can view it with any web browser.

Citation Details
Title: PhRMA code tightens limits on gift giving. (Hailed by consumer, Medical Groups).(Pharmaceutical Research and Manufacturers of America)
Author: Diana Mahoney
Publication: Skin & Allergy News (Magazine/Journal)
Date: August 1, 2002
Publisher: International Medical News Group
Volume: 33 Issue: 8 Page: 46(1)

Distributed by Thomson Gale
PhRMA code tightens limits on gift giving. : An article from: Skin & Allergy News

Categories : Trials
Comments (0)


Product Description
This digital document is an article from Skin & Allergy News, published by International Medical News Group on August 1, 2002. The length of the article is 657 words. The page length shown above is based on a typical 300-word page. The article is delivered in HTML format and is available in your Amazon.com Digital Locker immediately after purchase. You can view it with any web browser.

Citation Details
Title: PhRMA code tightens limits on gift giving. (Hailed by consumer, Medical Groups).(Pharmaceutical Research and Manufacturers of America)
Author: Diana Mahoney
Publication: Skin & Allergy News (Magazine/Journal)
Date: August 1, 2002
Publisher: International Medical News Group
Volume: 33 Issue: 8 Page: 46(1)

Distributed by Thomson Gale
PhRMA code tightens limits on gift giving. : An article from: Skin & Allergy News

Categories : Trials
Comments (0)


Product Description
This digital document is an article from Skin & Allergy News, published by International Medical News Group on August 1, 2002. The length of the article is 657 words. The page length shown above is based on a typical 300-word page. The article is delivered in HTML format and is available in your Amazon.com Digital Locker immediately after purchase. You can view it with any web browser.

Citation Details
Title: PhRMA code tightens limits on gift giving. (Hailed by consumer, Medical Groups).(Pharmaceutical Research and Manufacturers of America)
Author: Diana Mahoney
Publication: Skin & Allergy News (Magazine/Journal)
Date: August 1, 2002
Publisher: International Medical News Group
Volume: 33 Issue: 8 Page: 46(1)

Distributed by Thomson Gale
PhRMA code tightens limits on gift giving. : An article from: Skin & Allergy News

Categories : Trials
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Spin this one liberals.cnn.com

Bill and Hillary Clinton liquidated the contents of their blind trust upon learning it contained investments of $5 million to $25 million that could pose conflicts of interest or prove to be embarrassing to her presidential campaign.

The blind trust and a bank account valued in the same range place the Clintons’ total wealth at between $10 million and $50 million.

The Clintons looked at the contents of the blind trust in April under instructions from the Office of Government Ethics and sold the assets in May, according to a disclosure form filed Friday. The Clintons had the blind trust since former President Clinton was governor of Arkansas in 1983 and had no control over its transactions.

Once they peered inside it, they discovered it included investments in oil and drug companies, military contractors and Wal-Mart, campaign spokesman Phil Singer said.

The report, filed Friday with the Federal Election Commission and the Office of Government Ethics, provides the most detailed look at the Clintons’ holdings as their wealth has expanded since the former president left the White House in 2001.

The new report also shows that the former president made $16 million in speaking fees between January 2006 and Wednesday. So far this year, Bill Clinton has given 34 paid speeches for a total of $5.9 million. (Full story)

Trust included oil, drug companies
The blind trust held stock in pharmaceutical companies, including $250,000-$500,000 in Biogen Idec and Johnson & Johnson and $100,000-$250,000 in Amgen, Pfizer and GlaxoSmithKline. It also invested in General Electric and Raytheon, two leading defense contractors. The trust had a varied portfolio, with investments in numerous other companies, including Exxon Mobil, BP Amoco, Walt Disney and eBay.

The report said all the proceeds of the sales are being placed in a cash account. The massive unloading of stock means the Clintons face large capital gains taxes.

Though all the blind trust transactions were handled over the years by a trustee without the Clintons’ knowledge, some of the holdings could have been awkward for Hillary Clinton as she pursues the Democratic presidential nomination.

The blind trust held stock worth $100,000-$250,000 in NewsCorp, the parent company of Fox News, which many Democrats have denounced as biased against them. The trust also held stock in Wal-Mart and Wal-Mart de Mexico.

The senator served on the Wal-Mart board from 1986 to 1992, and was close with the Walton family that created the nation’s largest retailer. But she has recently called on the company to provide better worker benefits and last year her Senate campaign returned $5,000 to Wal-Mart’s political action committee. At the time, Clinton campaign spokeswoman Ann Lewis said the money was returned “because of serious differences with current company practices.”

Friday’s report comes on the heels of Hillary Clinton’s Senate disclosure report, made public Thursday, which only covered activity in 2006 and did not reflect this year’s liquidation of the blind trust.

Clinton and other presidential candidates were required to file financial disclosure documents with the Office of Government Ethics by May 15. But Clinton and Republican candidates Mitt Romney and John McCain asked for 45-day extensions because they all had blind trusts that the ethics office demanded be opened.

Campaign: Reporting goes ‘above and beyond’ requirements
“As a presidential candidate, Sen. Clinton was required to make her assets public,” campaign spokesman Howard Wolfson said. “As a result, she had to dissolve her blind trust. Upon its dissolution, she and the president chose to go above and beyond what was required of them and liquidate their assets in order to avoid even the hint of a conflict of interest.”

When it comes to family affluence, the reports show that the New York senator is the wealthiest of all members of Congress seeking the presidency. Among all presidential candidates, however, Republican Mitt Romney, the former Massachusetts governor, stands alone with assets of between $190 million and $250 million. Republican Rudy Giuliani and Democrat John Edwards have each reported assets of about $30 million.

Last year and this year, Bill Clinton earned fees from $100,000 to $450,000 speaking to such corporations as IBM, General Motors, and Cisco Systems, finance giants such as Goldman Sachs and Lehman Brothers, and trade groups such as the National Association of Realtors and the Mortgage Bankers Association. He also has been paid to speak to nonprofit or charity groups, including the TJ Martell Foundation, which finances leukemia research, Nelson Mandela’s Children’s Fund and, last March, to the Boys and Girls Club of Los Angeles.
Thanks to all that answered the question. Here’s another point, yes it was a blind trust, and I own mutual funds also but I know exactley what kinds of companies I am invested with, with the kind of money the Clintos have and had invested in these funds, it would be foolish to think they didn’t know how, who and where there money was invested. Just food for thought

Categories : Trials
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companies, pharmaceutical companies, Republicans, conservatives, oil companies, CEO’s…..the list is endless.
Can’t the man say anything positive….at all….ever????

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From today – drugs in drinking water

Extracts…

A vast array of pharmaceuticals — including antibiotics, anti-convulsants, mood stabilizers and sex hormones — have been found in the drinking water supplies of at least 41 million Americans, an Associated Press investigation shows.

The presence of so many prescription drugs — and over-the-counter medicines like acetaminophen and ibuprofen — in so much of our drinking water is heightening worries among scientists of long-term consequences to human health.

Full article

http://news.yahoo.com/s/ap/20080309/ap_on_re_us/pharmawater_i;_ylt=AumZLzQVefLBrqMCGdmwmfCs0NUE

So, You still from the tap raw, filter it OR buy bottled?

Thanks for taking part! :) )

Categories : Trials
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‘Evening News’ Blames Drug Industry for TB Scare
CBS reporter cites lack of vaccine development but excludes industry rebuttal.

The tuberculosis scare led all three major network news broadcasts on May 31. But CBS “Evening News” pointed fingers at one of the network’s favorite targets, the pharmaceutical industry.

Reporter Nancy Cordes compared the lack of vaccinations and treatments of this specific strain of tuberculosis to other “fast-moving infectious diseases,” including SARS, West Nile Virus and Avian Flu.

She followed with the blame game. “Why haven’t more drugs been developed to fight disease with the potential to kill thousands?” asked Cordes, the network’s Transportation and Consumer Safety correspondent.

“Pharmaceutical companies live to make a profit and if antibiotics, for example, because they’re used for usually 7 to 14 days, maybe as long as a month, can’t generate the same kind of profits as a new cholesterol agent or the new Viagra, which a person might take for years,” said Dr. Eric Nuermberger, an assistant professor of Medicine, Division of Infectious Diseases, at Johns Hopkins School of Public Health.

The Associated Press reported that only two other patients with this drug-resistant strain of tuberculosis have been treated at National Jewish Hospital since 2000. With only three cases documented in the last seven years, it would be difficult for the pharmaceutical industry have developed vaccination and treatment for this specific strain. That was a point CBS did not make.

The CBS story also neglected to include a response from the pharmaceutical industry about its development of medications for infectious diseases.

However, Pharmaceutical Research and Manufacturers of America (PHRMA) points out such products are not that easy to develop. There are various hurdles that must be cleared. PHRMA stated new medicines used to treat these diseases “are the result of medical research and development that can take as long as 15 years and cost nearly $1 billion to bring a new medicine from the laboratory to a pharmacy shelf.”

A Business & Media Institute study found while covering everything from medical “controversies” to breakthroughs, nearly 80 percent of the stories excluded the viewpoint of the pharmaceutical industry, failing to include either a company statement or a company spokesman.

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