Wednesday, August 27, 2008

Producing heparin without the heartache

or without the Chinese deliberatley substtituing chemical contamination in lieu of actually producing the product they were paid to produce...but, hey, who's quiblling over details...

US researchers have developed a chemoenzymatic strategy to synthesise the anticoagulant drug heparin and avoid the contaminant that has killed more than 80 people.

The breakthrough was presented at the ACS (American Chemical Society) National Meeting and Exposition in Philadelphia, US, earlier this week and described how Escherichia coli (E. coli) bacteria could be harnessed to synthesise the widely-used anticoagulant that has global annual sales of around $4bn (€2.7bn).

Heparin is produced by extraction from pig intestines and contaminated batches of the drug have been linked by the US FDA (Food and Drug Administration) to more than 80 deaths and hundreds of allergic reactions among patients treated with the drug during heart surgery and kidney dialysis.

The contaminated heparin was traced by the FDA to various batches imported from small, family-run workshops in China which supply about 70 per cent of the world’s supply.

While regulators called for greater cooperation and joint inspections of overseas active pharmaceutical ingredient (API) manufacturing plants, Professor Robert Linhardt of the Rensselaer Polytechnic Institute, US, and Associate Professor Jian Liu of the University of North Carolina, US, to search for an alternative method of production.

Prof. Linhardt was part of the team that identified the suspected contaminant as a structurally similar carbohydrate called oversulfated chondroitin sulfate.

"When we found the contamination, it was another sign that the way we currently manufacture heparin is simply unsafe," said Prof. Linhardt.

Researchers have been trying for years to develop a synthetic production method for the drug, however the first total synthesis described in 2003 by researchers from the Massachusetts Institute of Technology (MIT), US, produced only minute batches at a time and could not be economically scaled-up for commercial production.

The synthesis developed by Prof. Linhardt’s team uses a patented biosynthesis that uses enzymes expressed in E. coli bacteria to replicate the normal biosynthesis of natural heparin.

While the team has only used the technique to create the drug on a laboratory scale, scaling the process up should prove no more difficult than scaling-up the production of any other biological drug.

The group plans to begin the necessary preclinical and clinical trials needed to bring the synthetic heparin to market. If successful, the new heparin could be on the market in two to five years.

link to full article

Tuesday, August 26, 2008

FDA seizes drugs worth $74,000

How come we can't get this level of enforcement on real drugs??...

The US Food and Drug Administration (FDA) has ordered the seizure of $74,000 worth of Xiadafil VIP tablets after SEI Pharmaceuticals refused to withdraw them from the market.

A formal request for the recall of the erectile dysfunction dietary supplement was issued by the FDA after it discovered batches contained an undeclared active pharmaceutical ingredient (API).

SEI refused to recall the products leading to the FDA enlisting US Marshals to seize the batches to prevent more illegal Xiadafil from being sold.

Margaret Glavin, associate commissioner of the FDA’s Office of Regulatory Affairs, said: “Today’s seizure action shows that the FDA will take enforcement action to protect the public from dietary supplements that contain prescription drug ingredients that are potentially harmful to consumers.

“The FDA will not tolerate a company’s failure to take voluntary action to protect the public health after being given the opportunity by the FDA to do so.”

link to full article

Monday, August 25, 2008

Gene found for rare and deadly childhood cancer

News out of CHOP...

WASHINGTON (Reuters) - Researchers have found a gene that causes most inherited forms of neuroblastoma, a rare and deadly form of childhood cancer, and say the discovery points to new treatments.

Mutations in a gene called ALK were strongly linked to neuroblastoma, the researchers from the United States, Italy and Belgium reported on Sunday. They said several companies already are working on drugs that target this gene, which is also mutated in some cases of lung cancer and lymphoma.

"This discovery enables us to offer the first genetic tests to families affected by the inherited form of this disease," said Dr. Yael Mosse of The Children's Hospital of Philadelphia, who worked on the study.

"Furthermore, because there already are drugs in development that target the same gene in adult cancers, we can soon begin testing those drugs in children with neuroblastoma."

link to full article

Tuesday, August 19, 2008

Stem cell advance may help transfusion supplies

Don't tell Northfield or Biopure...

NEW YORK - Scientists say they've found an efficient way to make red blood cells from human embryonic stem cells, a possible step toward making transfusion supplies in the laboratory. The promise of a virtually limitless supply is tantalizing because of blood donor shortages and disappointments in creating blood substitutes.

Red blood cells are a key component of blood because they carry oxygen throughout the body.

Experts called the new work an advance, but cautioned that major questions had yet to be answered.

The research, published online Tuesday by the journal Blood, was reported by scientists at Advanced Cell Technology in Worcester, Mass., the University of Illinois at Chicago and the Mayo Clinic in Rochester, Minn.

link to full article

Monday, August 18, 2008

Tuesday, August 12, 2008

Researchers Correct Decline In Organ Function Associated With Old Age

Hurry Up!!!

As people age, their cells become less efficient at getting rid of damaged protein — resulting in a buildup of toxic material that is especially pronounced in Alzheimer's, Parkinson's disease, and other neurodegenerative disorders.

Now, for the first time, scientists at the Albert Einstein College of Medicine of Yeshiva University have prevented this age-related decline in an entire organ — the liver — and shown that, as a result, the livers of older animals functioned as well as they did when the animals were much younger. Published in the online edition of Nature Medicine, these findings suggest that therapies for boosting protein clearance might help stave off some of the declines in function that accompany old age. The study's senior author was Dr. Ana Maria Cuervo, associate professor in the departments of developmental & molecular biology, medicine and anatomy & structural biology at Einstein.

link to full article