Thursday, December 28, 2006

Inflammatory genes linked to salt-sensitive hypertension

I can't wait to tell my cardiologist...

check out the part towards the end of the article where the cause of stress in the teenage subject's is playing video games for an hour...if my kids only knew...

One key to your high blood pressure might just be your inflammatory genes.

It may sound odd but mounting evidence suggests that inflammation, a part of the immune response implicated in diseases such as cancer, Alzheimer’s and diabetes, may also help translate stress into high blood pressure.

“There is a concept that hypertension is an inflammatory condition,” says Dr. Haidong Zhu, molecular geneticist at the Medical College of Georgia. She’s among the scientists who believe the connection between stress, inflammation and hypertension is the kidneys’ ability to release sodium.

When stress activates the sympathetic nervous system (the fight-or-flight mechanism), the body increases production of interleukin 6, a pro-inflammatory factor, which ultimately leads to production of other inflammatory factors such as C reactive protein.

Stress also prompts the body to hold onto sodium to help temporarily raise blood pressure so you can deal with the situation, says Dr. Gregory Harshfield, director of MCG’s Georgia Prevention Institute and an expert on what happens when the body doesn’t let go afterward. It’s called impaired stress-induced pressure natriuresis, which Dr. Harshfield has documented in young, healthy teens.

link to full article

Wednesday, December 27, 2006

Biotech industry surging in Maryland

Life Sciences as the job creation machine...look for more on this topic...

Maryland's bioscience industry is moving beyond its traditional research role and reaching for commercial success on par with the highly successful biotech sectors in San Francisco and Boston.
This year marked significant progress for the state's biotech industry as it starts to develop new drugs, increase venture capital investment and move out of the shadows of the region's powerful academic and federal research facilities, such as the National Institutes of Health and Johns Hopkins University.
"What we saw this year was more companies turn the corner, not in terms of drug approvals, but in terms of receiving significant money and the realization of new drugs coming to market," said Bob Eaton, president of MdBio Foundation, the trade association representing the biotech companies.
Biotechnology drugs are the most expensive drugs on the market and cost in the billions of dollars to produce and market. Biological drugs include antibodies, oncology treatments and vaccines and are created from living organisms, unlike pharmaceutical drugs that are synthetically manufactured.

link to full article

MIT creates 3-D scaffold for growing stem cells

CAMBRIDGE, Mass.-Stem cells grew, multiplied and differentiated into brain cells on a new three-dimensional scaffold of tiny protein fragments designed to be more like a living body than any other cell culture system.

An MIT engineer and Italian colleagues will report the invention-which may one day replace the ubiquitous Petri dish for growing cells-in the Dec. 27th issue of the PLoS ONE. Shuguang Zhang, associate director of MIT's Center for Biomedical Engineering, is a pioneer in coaxing tiny fragments of amino acids called self-assembling peptides to organize themselves into useful structures. Working with visiting graduate student Fabrizio Gelain from Milan, Zhang created a designer scaffold from a network of protein nanofibers, each 5,000 times thinner than a human hair and containing pores up to 20,000 times smaller than the eye of a needle.

The researchers were able to grow a healthy colony of adult mouse stem cells on the three-dimensional scaffold without the drawbacks of two-dimensional systems.

In addition to helping researchers get a more accurate picture of how cells grow and behave in the body, the new synthetic structure can provide a more conducive microenvironment for tissue cell cultures and tissues used in regenerative medicine, such as skin grafts or neurons to replace brain cells lost to injury or disease.

The scaffold itself can be transplanted directly into the body with no ill effects.

"The time has come to move on from two-dimensional dishes to culture systems that better represent the natural context of cells in tissues and organs," said Zhang, whose coauthors on the paper, in addition to Gelain, are from institutes and medical schools in Milan, Italy.

link to full article

NNE scoops up Pharmaplan

The consolidation of the engineering industry continues...and it includes our European collegues...

20/12/2006 - NNE and Fresenius ProServe yesterday announced they had reached an agreement by which NNE will acquire Fresenius’ subsidiary, engineering company Pharmaplan GmbH.

Fresenius ProServe has sold the company in a further step to focus its attention on the hospital and healthcare business, and its aspirations to participate in the privatisation of the hospital market.
Neither company are disclosing financial details regarding the acquisition, which is effective as of 1 January 2007. The companies will however have to wait for anti-trust approval from the relevant authorities before the deal can be finally implemented; this is expected no sooner than March 2007.

Pharmatec, a subsidiary of Pharmaplan that manufactures pure steam, pure water and sterilisation equipment, is not included in the transaction and will be divested by Fresenius at a later date.

Pharmaplan provides consulting, engineering and qualification/validation services for the pharmaceutical industry, supplementing NNE's business with delivery of turnkey facilities and key pharmaceutical processes. NNE contributes to the partnership with expertise in biotechnology, cleanroom and automation.

Operating under the name NNE Pharmaplan, the company will be headquartered in Copenhagen, Denmark, but will also maintain Pharmaplan's current site near Frankfurt, Germany, as an additional European hub.

link to full article

Tuesday, December 26, 2006

New Drugs Declining, Research Costs Increasing

This is not good news...

Drug companies are becoming less innovative, with the number of new drugs being developed failing to keep pace with the substantial increases in spending on research and development, according to congressional investigators.

A report released yesterday by the Government Accountability Office, the investigative arm of Congress, found that annual research and development spending by the pharmaceutical industry increased 147 percent, to $60 billion, between 1993 and 2004. At the same time, the number of new drug applications to the Food and Drug Administration grew by only 38 percent, and it generally has declined since 1999.

What is more, about two-thirds of the new applications were for drugs that simply represent modifications to existing medicines, while 32 percent were for potentially innovative new drugs.

"Over the past several years it has become widely recognized throughout the industry that the productivity of its research and development expenditures has been declining," investigators wrote in the 52-page report. "That is, the number of new drugs being produced has generally declined while research and development expenditures have been steadily increasing."

link to full article

Mistletoe for Cancer? Maybe Not

Don't get too caught up in the holiday spirit!!!...

Mistletoe Extract May Be Harmful, British Doctors Say

Dec. 21, 2006 -- Taking mistletoe for cancercancer may be ineffective and possibly harmful, British doctors report.

"I recommend mistletoe as a Christmas decoration and for kissing under, but not as an anticancer drug," writes Edzard Ernst, MD, PhD, FRCP, FRCPEd, in BMJ (formerly called British Medical Journal).

Ernst directs the complementary medicine department at the University of Exeter and Plymouth's medical school in England.

He points out that in Europe many cancer patients take mistletoe preparations and that Germany's insurance system covers mistletoe treatment.

In the U.S., the FDA hasn't approved any mistletoe cancer drugs.

Mistletoe studies have yielded mixed results and have often been "methodologically weak," Ernst says.

BMJ includes a report about a woman in Wales with inflammation under the skin where she had given herself mistletoe extract injections over the past year.

The 61-year-old woman previously had a type of cancer called lymphomalymphoma. With her cancer in remission, she began giving herself three weekly injections of mistletoe extract in her belly.

Ten months later, she had a breast tumor surgically removed. At a follow-up appointment, she complained that she had a mass in her abdomen.

link to full article

Tuesday, December 19, 2006

Second "Large Biotech" Interested In Devens, Massachusetts; More Jobs To Genetown

The job making machine continues forward...

-- What do a hummingbird and Magellan have in common?

State and local officials hope the answer is that they're both bringing lots of jobs to Massachusetts. Hummingbird and Magellan are both code names used this year for big, secret projects at Devens. The first one, Hummingbird, wasn't very secret for very long -- the news quickly broke that biopharmaceutical giant Bristol-Myers Squibb was considering Devens, among several other sites, for a large biomanufacturing plant.

link to red orbit article

Friday, December 15, 2006

Virgin process can produce stem cells

I'm going to guess that we'll be hearing about this subject again...

WASHINGTON (Reuters) - Mouse embryos created through a "virgin birth" process called parthenogenesis show that egg cells can be a source of valued embryonic stem cells, researchers said on Thursday.

The cells can be closely matched to the immune system of the recipient, making them a potential source for transplants, the researchers report in Friday's issue of the journal Science.

There are fewer obstacles to developing these stem cells than by using cloning technology, also called somatic cell nuclear transfer, researchers said.

"I think it is a much more real-world possibility than nuclear transfer," said Dr. George Daley of Children's Hospital and Harvard Medical School in Boston, who led the study.

If the experiment could be reproduced in humans, such cells might provide an alternative way to produce tailored tissues for transplanting, or for studying disease, Daley said in a telephone interview.

"We are aggressively trying to produce human parthenogenetic embryonic stem cells," Daley said.

link to full article

Monday, December 11, 2006

"Inkjet" printer helps organize stem cells

the second page of the article explains the process...

WASHINGTON (Reuters) - An "inkjet"-style printer for stem cells may help scientists put the precious master cells to good use, U.S. researchers said on Sunday.

A team of bioengineers at Carnegie Mellon University's Robotics Institute in Pittsburgh joined forces with stem cell biologists at the University of Pittsburgh School of Medicine to create the system, which they eventually hope will help them make stem cells grow into complex tissues.

Stem cells are like the raw clay of the body, undifferentiated into specific tissue types such as brain cells, skin cells or liver cells.

Doctors hope they hold the key to a whole range of regenerative therapies, but they are tricky to find and to work with. And it is not always easy to get them to mature into the desired cells.

Tissue is complex, made up of a variety of different types of cells, and they must be layered together in the right pattern to work properly.

link to full article

Friday, December 08, 2006

Senate approves Bush pick to lead FDA

WASHINGTON (Reuters) - The U.S. Senate on Thursday overwhelmingly approved the nomination of cancer expert Dr. Andrew von Eschenbach to run the Food and Drug Administration, despite objections from several Republican senators.

The urology surgeon and oncologist has served as acting FDA chief since September 2005. He was nominated earlier this year by President George W. Bush to take the job permanently.

The FDA regulates medicines, medical devices, most foods and other products that sustain about a quarter of the U.S. economy. The agency has lacked a permanent leader for all but 18 months of Bush's nearly six years in office.

Von Eschenbach was approved on a vote of 80-11.

link to full article

CROs – where is the money being spent?

another outsourcing/ offshoring issue...

05/12/2006 - The contract research organisation (CRO) industry is in full swing as the clinical trial outsourcing trend continues, but where is the money being spent?

Roughly 1,000 CROs are in operation across the world and this number continues to grow. The market is now worth $16bn (€12bn), according to research firm Datamonitor.
Giving a breakdown of this spending, 17 per cent of the total clinical research outsourced is preclinical work; six per cent is in Phase I; 14 per cent is during phase II-III and 16 per cent is postmarketing related.

Central lab services account for a further twelve per cent, while the remaining 28 per cent is being spent on other services such as data management and site management, according to figures from a 2004 Tufts University analysis.

Of the large global players, Quintiles is leading the pack, with 11 per cent of the global market share. Covance and Charles River laboratories share second spot, holding about eight per cent each, with PPD not far behind on seven per cent.

link to full article

Thursday, December 07, 2006

Pfizer manufacturing plant in question after torcetrapib blow

sometimes even the best of planning can be "overtaken by events"...

how often are facility designs completed and then either scrapped or re-done for some other use?...more than most companies would like to admit, even if it's not very often...

05/12/2006 - A hefty investment by Pfizer in an Irish manufacturing facility could prove to be a waste after the potential blockbuster it was designed to make has been canned.

Pfizer announced that it will stop the development of its cholesterol drug torcetrapib after clinical trial results showed an increased risk of death in patients.
Since 2003 Pfizer has been undertaking a $90m (€68m) investment and expansion at an existing Irish manufacturing site in Loughbeg, Cork, so that it could make the new drug, a combination of torcetrapib – a cholesteryl ester transfer protein (CETP) inhibitor – and Pfizer's current blockbuster Lipitor (atorvastatin).

The company was touting the combination as a “major new cardiovascular treatment” and finished construction of the new extension in the middle of 2005, which included the design and installation of a fluid bed drier and granulation system over three floors, along with solids handling and management systems, specifically for the production of the new drug.

link to full article

Monday, December 04, 2006

Gates Foundation to separate assets from grant-making in January

SEATTLE -- The Bill & Melinda Gates Foundation will be altering its internal financial structure to cleanly separate its program work from investment of its assets, the foundation announced this week.

The reorganization plan, which takes effect in January, will also help the foundation accommodate an infusion of stock from Warren Buffett, the organization announced Wednesday. Buffett said in June he would be giving most of his money to the foundation in annual installments worth about $1.5 billion. His first gift was made in August.

Buffett has given the foundation a few years to ramp up before requiring that it distribute his entire donation each year, which will effectively double the dollar amount of grants the foundation makes.

In the same announcement, the foundation for the first time set a limit on its charitable work, saying it would spend all its money within 50 years of the death of Gates or his wife, whoever lives longest. The time limit gives the organization incentive to work harder to achieve more of its goals within the lifetimes of the Gateses and their children, officials said.

link to full article