Plans by  FDA to Adopt stricter standards for Bioequivalence, Bioavailability for generic drugs could sound trouble for Indian Generic Manufactures. Already most of the smaller companies are finding it difficult to get FDA approval letters. QSR Draft Guidance An industry working group has urged the FDA to consider adopting its guidance to outline quality system requirements (QSR) for bioequivalence and bioavailability testing during drug clinical trials.

There was a recent report in NY times that mentioned about several thousand patients receiving nitroglycerin tablets that were not approved by FDA http://www.nytimes.com/2010/03/27/business/27nitro.html

FDA recently evaluated 2070 human studies conducted between 1996 and 2007. These studies compared the absorption of brand name and generic drugs into a person’s body. These studies were submitted to FDA to support approval of generics. The average difference in absorption into the body between the generic and the brand name was only 2.3%. Some generics were absorbed slightly more, some slightly less. This amount of difference would be expected and acceptable, whether for one batch of brand name drug tested against another batch of the same brand, or for a generic tested against a brand name. In fact, there have been studies in which branded drugs were compared with themselves, as well as with a generic. As a rule, the difference for the generic-to-brand comparison was about the same as the brandto- brand comparison” (www.fda.gov/ Drugs/ResourcesForYou/Consumers/ BuyingUsingMedicineSafely/Under standingGenericDrugs/ucm167991. htm)

Fore more updates attend the event below

Attend the http://www.informaglobalevents.com/event/beba

International Stem Cell Corporation (OTCBB:ISCO), http://www.intlstemcell.com, today added two world-leading immunogeneticists to its scientific advisory board. They and ISCO scientists will study the immune-matching properties of ISCO's human parthenogenetic stem cell (hpSC) technology and the potential for each hpSC-derived therapeutic cell to be an immune-match for millions of people.

Dr. Hans-Dieter Volk, Professor of Immunology and Chair of the Institute of Medical Immunology and Berlin-Brandenburg Center for Regenerative Therapies (BCRT) at Charité Universitätsmedizin in Berlin, and Dr. Matthias von Herrath, Professor at the La Jolla Institute of Allergy and Immunology at University of San Diego, have agreed to join ISCO's scientific advisory board. Both have dedicated their careers to experimental and clinical immunology and are highly regarded immunogenetics experts internationally. They will be most valuable as ISCO attempts to demonstrate the unique immune-matching benefits of the hpSC technology experimentally and in clinical practice.

"We believe that providing human cells that can minimize rejection though immune-matching to the recipient is one of the most important tasks in developing effective regenerative medicine therapies," says Dr. Simon Craw, Vice President at ISCO. "We look forward to Drs. Volk and von Herrath helping us try to demonstrate how that need can be met with our parthenogenetic stem cells."

Embryonic stem cells (hESC) almost invariably have different forms of genes (called "alleles") at each genetic position of the paternal and maternal chromosomes, i.e. they are "heterozygous." This includes the human leukocyte antigen ("HLA") genes that are largely responsible for the distinction between "self" and "foreign," and thus acceptance or rejection of transplants. Since hESC are derived from fertilized embryos, they carry the genes of a unique individual, thus the therapeutic cells derived from hESC will carry HLA alleles that can be recognized as foreign and be rejected by most patients unless they receive immunosuppressive therapy. Such therapy is costly, has significant side effects, and often is disabling in the long term.

Like most individuals in the population, induced pluripotent stem cells ("iPS" cells) and adult stem cells are also predominantly heterozygous because they carry paternal and maternal chromosomes. They are a perfect immune match to the patient they came from and are therefore typically administered back to that same individual ("autologous therapy"). However, they would likely be rejected by most other recipients. Autologous therapy is time-consuming and expensive, which goes against the cost containment pressures globally. In addition, the quality of the therapy is directly related to the ability to secure clinically sufficient numbers of functional cells from the patient, which often poses a significant problem in clinical practice.

In contrast, the hpSCs developed by ISCO are derived from unfertilized eggs ("oocytes") that have been shown in peer-reviewed journals to exhibit unlimited proliferation potential and are pluripotent (can become cells from all three germ layers that form a human being). Most significantly, hpSC can be created in a "homozygous" state, where the alleles, including the HLA alleles, are the same at each genetic position. When these HLA alleles are also found with a high frequency in a population, these "HLA-homozygous" stem cells and their therapeutic derivatives have the potential to be immune matched to millions of people. For example, ISCO's first homozygous stem cell line with high-frequency HLA alleles has the potential to be immune matched to an estimated 75 million people worldwide.

Dr. Volk says: "Using my experience from transplantation immunology and medicine during the past three decades, I am very pleased to help ISCO in their efforts to make its hpSC technology a clinical reality where therapeutic cell derivatives will be immune matches for millions of people worldwide." Dr. von Herrath continues: "While stem cell technologies generally offer great regenerative potential, most clinical applications will be limited by immune rejection. I look much forward to joining ISCO in their quest for making stem cell-derived therapy a practical and attractive clinical option for many degenerative diseases."

Besides the immunogenetic developments, ISCO is advancing its hpSC technology into the differentiation of hpSC into therapeutic cells and tissues and into the establishment of processes and facilities to produce clinical-grade cells. The company is seeking to demonstrate the therapeutic potential of its hpSC technology as a safe, efficient, and superior alternative to other sources of stem cells for human therapy.

ABOUT INTERNATIONAL STEM CELL CORPORATION (ISCO.OB):

International Stem Cell Corporation is a California-based biotechnology company focused on therapeutic and research products. ISCO's core technology, parthenogenesis, results in creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells with minimal immune rejection after transplantation into hundreds of millions of individuals of differing sexes, ages and racial groups. This offers the potential to create the first true stem cell bank, UniStemCell™, while avoiding the ethical issue of using fertilized eggs. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology. More information is available at ISCO's website, http://www.internationalstemcell.com.

To subscribe to receive ongoing corporate communications please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0.

FORWARD-LOOKING STATEMENTS

Statements pertaining to anticipated technological developments and therapeutic applications, and other opportunities for the company and its subsidiary, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "should," "believes," "plans," "anticipates," "expects," "estimates") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update these forward-looking statements.

Key Words: Stem Cells, Biotechnology, Parthenogenesis

International Stem Cell Corporation
Kenneth C. Aldrich, Chairman
760-940-6383
kaldrich@intlstemcell.com
or
Brian Lundstrom, President
760-640-6383
bl@intlstemcell.com

• Cancer Stem Cells: Back to Darwin? (review) [FriendFeed entry][Connotea bookmark][PubMed citation] http://bit.ly/csTyxT
• Cancer stem/progenitor cells are highly enriched in CD133+CD44+ population in hepatocellular carcinoma [FriendFeed entry][PubMed citation] http://bit.ly/bwUz7C
• The nuclear receptor tailless induces long-term neural stem cell expansion and brain tumor initiation [FriendFeed entry][News release][PubMed citation] http://bit.ly/cCjVZL
• Hedgehog Signaling and Cancer Stem Cells in Hematopoietic Cell Malignancies (USPTO Application) [FriendFeed entry] http://bit.ly/bSbbTF
• (WO2010037134) Multi-stage stem cell carcinogenesis [FriendFeed entry][WIPO entry] http://bit.ly/cnksOu
• (WO2010037041) Frizzled-binding agents and uses thereof (to target CSC ) [FriendFeed entry] http://bit.ly/aaSJNI
• Epithelial-Mesenchymal Transition (EMT) in Tumor-Initiating Cells and Its Clinical Implications in Breast Cancer (review) [FriendFeed entry][Connotea bookmark][PubMed citation] http://bit.ly/cEcBrJ
• Ovarian cancer stem-like side-population cells are tumourigenic and chemoresistant [FriendFeed entry][Connotea bookmark][PubMed citation] http://bit.ly/cvoGt1
• Emerging strategies for the identification and targeting of cancer stem cells (review) [FriendFeed entry][PubMed citation] http://bit.ly/bGOGfd
• Stem cells in human breast cancer (OA review) [FriendFeed entry][ResearchGATE entry][PubMed citation] http://bit.ly/aF9E8U
• Side-population cells in luminal-type breast cancer have tumour-initiating cell properties, and are regulated by HER2 expression and signalling [FriendFeed entry][PubMed citation] http://bit.ly/92VkLU
• Hypoxia inducible factors in cancer stem cells (minireview) [FriendFeed entry][PubMed citation] http://bit.ly/bGBdxN
• Classic view of cancer challenged by new theory (about the CSC model) [FriendFeed entry] http://bit.ly/decqFe
• New hope in the horizon: cancer stems cells (OA review) [FriendFeed entry][PubGet entry][Full text PDF] http://bit.ly/9HLmV0

(HealthDay News) -- Men with jobs that expose them to high levels of sunlight are less likely to develop kidney cancer than those with little or no sunlight exposure at work, says a new study.

Previous research suggests that vitamin D, which is obtained from sun exposure and certain foods and supplements, may help prevent some cancers. Vitamin D is metabolized and most active within the kidneys.

This new study included 1,097 male and female kidney cancer patients and 1,476 healthy people in Europe who were interviewed about their work history and other demographic information.

Men with the highest levels of work-related exposure to sunlight were 24 percent to 38 percent less likely to have kidney cancer than other men. This association between job-related sunlight exposure and kidney cancer risk was not seen in women.

The study is published online March 8 in the journal Cancer. Read more...

Ayurtox for Body Detoxification

OCEANSIDE, California - April 8, 2010 - International Stem Cell Corporation (ISCO.OB), http://www.internationalstemcell.com, announces today that it’s wholly owned subsidiary, Lifeline Skin Care Inc., has achieved positive results in human safety tests of its cosmetic products and is moving forward with arrangements with Cosmetic Enterprises Ltd. for the manufacture of three cosmetic products. These developments allow Lifeline Skin Care to plan a launch of its cosmetic product line in the late summer or fall of 2010.

Cosmetic face products developed by Lifeline Skin Care Inc., contain extracts from human parthenogenetic stem cells (hpSC) combined with a vitamin complex and other active ingredients. The products utilize a form of nanotechnology to deliver concentrated active ingredients to damaged skin. Laboratory tests show that an active “complex” of stem cell extract has the ability to rejuvenate skin. Also, early human trials show that these cosmetic products moisturize skin and strongly indicate the ability to decrease the depth of wrinkles and provide factors that lead to anti-aging effects.

Lifeline Skin Care is working with Cosmetic Enterprises, Ltd., located in California, to formulate and package its unique skin care product. Cosmetic Enterprises is a well-known OTC drug licensed manufacturer with over 30 years of experience. Lifeline Skin Care’s “parthenogenetic stem cell complex” the product’s active ingredient, is made in Lifeline Skin Care’s laboratory in Oceanside, California.

According to Gregory S. Keller, MD, FACS, “These positive safety studies in human testing are important, especially considering that preliminary human trial data show that products of the production of International Stem Cell’s parthenogenetic stem cells have significant beneficial effects on the skin and might also provide long term benefits in reducing wrinkles and other visible signs of aging. These results are a significant step forward in making this unique product available to the public.” Dr. Keller was named the 2007 “Specialist of the Year in Facial Cosmetic Surgery” in Strathmore’s “Who’s Who”.

The results of recent human safety tests show there were no identifiable signs or symptoms of sensitization (contact allergy). Safety testing is a series of tests to insure the product does not cause negative reactions such as irritation to the skin. This completed round of testing allows Lifeline Skin Care to move forward confidently with its commercial manufacturing plans.
International Stem Cell Corporation is a pioneer in development of a new class of stem cells called “human parthenogenetic stem cells” which avoid critical ethical issues by eliminating the need to use fertilized embryos and can be immune-matched to large segments of the population. As of today, ISCO has successfully derived 10 hpSC lines. One of these lines (hpSC-Hhom-4), carries the most common immune type found across racial groups within the US population and can be immune-matched to millions of people.

ABOUT INTERNATIONAL STEM CELL CORPORATION (ISCO.OB):
International Stem Cell Corporation is a California-based biotechnology company focused on therapeutic and research products. ISCO’s core technology, parthenogenesis, results in creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells with minimal immune rejection after transplantation into hundreds of millions of individuals of differing sexes, ages and racial groups. This offers the potential to create the first true stem cell bank, UniStemCell™, while avoiding the ethical issue of using fertilized eggs. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology. More information is available at ISCO’s website, http://www.internationalstemcell.com.

To subscribe to receive ongoing corporate communications please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0.

FORWARD-LOOKING STATEMENTS
Statements pertaining to anticipated technological developments and therapeutic applications, and other opportunities for the company and its subsidiary, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "should," "believes," "plans," "anticipates," "expects," "estimates,") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update these forward-looking statements.

Key Words: Skin Care, Stem Cells, Biotechnology, Parthenogenesis

CONTACTS:
International Stem Cell Corporation
Kenneth C. Aldrich, Chairman
760-940-6383
kaldrich@intlstemcell.com
Or
Lifeline Skin Care Inc.
Ruslan Semechkin, PhD, CEO
760-940-6383
ras@intlstemcell.com

In most areas of medicine, doctors have historically tried to glean something about the underlying cause of a patient’s illness before figuring out a treatment that addresses the source of the problem. When it came to mental or behavioral disorders in the past, however, no physical cause was detectable so the problem was long assumed by doctors to be solely “mental,” and psychological therapies followed suit.

Today scientific approaches based on modern biology, neuroscience and genomics are replacing nearly a century of purely psychological theories, yielding new approaches to the treatment of mental illnesses.

[More]

Be Your Own Doctor

There various vegetables , fruits and nuts readily available in our kitchens and our local markets. But we often forget the medicinal value and no soon we have a ailment we run to the doctors for help. It is very important to consult a doctor and take the medication, but the herbal medicenes that are available readily at our kitchen could help us if the ailment is very nominal. For eg. if someone has a gastric problem, or an acidity problem , then there are so many condiments, and other herbal cures which are at our reach, but that goes unnoticed or being ignored. I give you a few remedies on very normal and common ailments from the vegetables, condiments, fruits etc available at home.

1. Amla (indian gooseberry) Genera-Phylanthus Speices-emblica Read more...

Kama Raja Old Formula for Penis Enhancement!