Red Cross Fined $4.2 Million Over Blood Safety

Uh-oh...

WASHINGTON (Reuters) - The U.S. government fined the American Red Cross $4.2 million for failing to ask blood donors proper screening questions and skipping other steps meant to keep the blood supply safe, officials said on Friday.

The fine, the largest ever levied by the Food and Drug Administration for a blood safety violation, follows a multiyear battle between the FDA and the Red Cross, which collects about 45 percent of the blood donated in the United States each year for transfusions.

The agency said it had no evidence that any blood collected by the Red Cross harmed people who got transfusions.


But FDA officials said the failure to follow multiple safeguards increased the risk that patients could receive blood tainted by an infectious disease.

"It is not acceptable that the quality systems failed in this way," Margaret O'K. Glavin, FDA associate commissioner for regulatory affairs, told reporters.

link to full article

Senators Denounce Scientist's Stem Cell Claims

The political football stem cell research takes another bounce...

Confusion Over Harm to Embryos In Study at Issue

By Rick Weiss
Washington Post Staff Writer
Thursday, September 7, 2006; Page A04

Two senators who strongly support human embryonic stem cell research lashed out yesterday at the scientist who recently reported the creation of those cells by a method that does not require the destruction of embryos, saying the scientist and his company have harmed the struggling field by overstating their results.

"It's a big black eye if scientists are making false and inaccurate representations," a combative Sen. Arlen Specter (R-Pa.) said during a hearing of the Senate Appropriations labor, health and human services subcommittee, which he chairs.

Sen. Arlen Specter: "It's a big black eye if scientists are making false and inaccurate representations."

Robert Lanza of Advanced Cell Technology (ACT) in Worcester, Mass., defended his work and the company's statements. "Our paper is 100 percent correct," said the visibly shaken scientist, referring to the highly publicized article that appeared in the Aug. 24 issue of the journal Nature.

link to full article

ISPE Blog at the Annual Meeting

I just got an e-mail today from Marsha Strickhouser who is the Public Relations Manager for ISPE...

The Annual Meeting will be having a dedicated blog this time around...

I'm really looking forward to this and I hope everybody gets involved with this...it should be a lot of fun...

Look for links and posts to be coming soon...

ISPE Annual Meeting
05-08Nov06
Orlando, FL

Maryland mulls 'vaccine manufacturing capital of the world' dream

some states really see the biosciences as an economic engine...It would be interesting to gather all this together into one package...


31/08/2006 - Bruised by Novartis’s snub over a $600m (€466m) vaccine plant, Maryland has commissioned a study on what more the state can do to attract a major cell culture vaccine manufacturing facility there.

Although the study has not yet been released, In-PharmaTechnologist.com has learned that in its findings the report suggests that the city of Baltimore and the state of Maryland will need to work much harder to attract biotech investment given the financial incentives that other states provide.
The state had been in the running with North Carolina and Georgia for Novartis's plant, which will be the first facility in the US to use novel cell culture technology, but Aris Melissaratos, Maryland's secretary of the Department of Business and Economic Development, said that other states were willing to give away free land and so Maryland couldn't compete with that sweetener given this region's high real estate prices.

Nevertheless, the state still has several firms that have committed to building manufacturing plants there, such as MedImmune and Emergent BioSolutions, yet the selection of North Carolina by Novartis stroke a raw nerve among those who have higher aspirations for Maryland.

“Maryland is doing exactly what it can and should be doing to attract more biotech firms and the vaccine feasibility study is a prime example,” Morgan Wallace, of the Economic Alliance of Greater Baltimore, the organisation behind the report, told In-PharmaTechnologist.com.

link to full article from in-pharma tech

'Virtually untreatable' TB found

Now here's the really scary story...


About 1.7 million people die from TB globally each year
A "virtually untreatable" form of TB has emerged, according to the World Health Organization (WHO).
Extreme drug resistant TB (XDR TB) has been seen worldwide, including in the US, Eastern Europe and Africa, although Western Europe has had no cases.

Dr Paul Nunn, from the WHO, said a failure to correctly implement treatment strategies was to blame.

TB experts have convened in Johannesburg, South Africa, to discuss how to address the problem.

TB presently causes about 1.7 million deaths a year worldwide, but researchers are worried about the emergence of strains that are resistant to drugs.

link to full article

Companies help schools produce bio-hires

Some states really do see the biosciences as an economic engine...

Biotech companies think globally about product development and marketing. But for their workforces, they need to hire locally.

What began in 2002 as a partnership between industry, government and local community colleges to retrain displaced Bay Area airline workers following Sept. 11 has turned into an award-winning, widely copied job-training program to build biotechnology's employment pipeline.

Skyline College in San Bruno was one of the first to begin working with Genentech to train workers specifically for entry-level biomanufacturing jobs.

Since its program began in 2002, 160 students have enrolled in the 12-week certificate program. Of 153 who completed it, 135 have taken full-time jobs and 20 are working toward their certificates. The average starting wage for certificate holders is $18.89 an hour.

Students who've completed a certificate program hold support positions like bioprocess technician, which involves preparing media and solutions for bioprocesses and reviewing documentation and calculations. Genentech would not say what percentage of its workforce holds such entry-level, biomanufacturing positions, but said this year it expects to increase its headcount by 15 percent company-wide. The 1,500 new employees will work in all departments at all levels.

Skyline's certificate program was created in close collaboration with Genentech to help the biotech giant meet its growing need for entry-level workers. Monica Poindexter, Genentech's associate director for corporate diversity and college programs, called the program "extremely successful."

Others in the industry have noticed. William Watson, director of the center for Workforce Development at Skyline, said that more than 25 local companies, from Applied Biosystems to Bayer to Chiron (now part of Novartis), now employ Skyline certificate holders.

link to full article

ICH Q8 & Q9- ISPE/ PDA Seminar

I always wondered when PDA was going to get together with ISPE

Challenges of Implementing ICH Q8 & Q9- Practical Applications

December 6-7
Washington DC
USA

Players storing children's stem cells as "repair kit": paper

LONDON (Reuters) - Some leading English soccer players are storing stem cells from their newborn babies as a potential future treatment for their own career-threatening sports injuries, according to a report in the UK Sunday Times newspaper.

Players are freezing the cells taken from the umbilical cord blood of their babies as a possible future cure for cartilage and ligament problems. Stem cells can be used to regenerate damaged organs and tissue because they are the earliest form of cells.

The paper quoted one unnamed Premier League player from a north west club as saying: "We decided to store our new baby's stem cells for possible future therapeutic reasons, both for our children and possibly for myself.

"As a footballer, if you're prone to injury it can mean the end of your career, so having your stem cells - a repair kit if you like - on hand makes sense."

link to full article

'Ethical' stem cell lines created

from our friends at BBC news...

Human embryonic stem cell lines have been generated without embryos being destroyed, according to researchers.
A US team created stem cell lines by removing single cells from embryos, a process that left them intact, they report in the journal Nature.

At present, growing this type of stem cell results in embryo destruction.

The researchers say their findings may remove some of the ethical barriers to this field and provide a way of bypassing current US legislation.

In 1995, the US congress passed an amendment stating that the government would not fund research in which human embryos were destroyed.

And in 2001, President Bush declared federal funding would only be available for research using the 61 human embryonic stem cells lines already in existence, where a "life or death decision had already been made".

This meant that no new lines could be created, whether from existing embryos or cloned embryos.

US stem cell researchers said the funding limits had ensured the US lagged behind in this field of research, limiting new studies to private companies, while pro-lifers hailed the decision.

Scientists believe stem cells may one day help to combat a range of diseases, such as Alzheimer's or Parkinson's disease, or to repair spinal cord injury.

link to full article

Proton Therapy Used More to Treat Cancer

HOUSTON (AP) -- Francis Maloy lay on his back on a narrow, metallic table, waiting for a giant machine to bombard the tumor in his chest with proton beams.

"The last time I heard about protons I was in college taking physics," said Maloy, a 68-year-old retired Army colonel from Stuart, Fla., just before the procedure.

Maloy, who has advanced lung cancer, is one of the first patients being treated at the University of Texas M.D. Anderson Cancer Center's new $125 million Proton Therapy Center.

It is the largest of the nation's four centers that treat cancer by targeting proton beams narrowly on the tumor itself, sparing the healthy tissue that with typical X-ray radiation would be blasted along with the cancer cells.

While newer forms of traditional radiation, with the help of computers, also allow doctors to precisely target a tumor, proton therapy allows higher levels of radiation. For a patient like Maloy, it could be his best hope at this stage of his cancer.

Dr. James Cox, chief of radiation oncology at M.D. Anderson, wasn't always a believer in the technology. But he said studies have shown proton therapy allows a higher level of radiation on the tumor, with less damage to healthy tissue and fewer side effects, such as loss of appetite, diarrhea and headaches. "That was the breakthrough, what changed my mind," he said.

"Anytime you have cancer in any location where it requires a high dose for control and it's close to sensitive normal structures (such as the eye, the skull, the spinal cord) that's an indication for proton therapy," said Cox. It also is useful for treating cancer in children, who are more sensitive than adults to the side effects of radiation.

Doctors at M.D. Anderson are using proton beam treatments mostly on patients whose cancers are so early in development that a cure is possible. But it is also being used on people like Maloy, who have relatively advanced cancers, Cox said.

Proton therapy has been around since the mid-1950s but was done mostly at research facilities, according to the National Association for Proton Therapy. The world's first hospital-based facility opened in 1990 at Loma Linda University Medical Center in California.

link to full article

Scientists hail breakthrough in bird flu drug quest

LONDON, Aug 16 (Reuters) - Scientists said on Wednesday they had made a breakthrough in the race to develop a drug for the H5N1 bird flu virus if it mutates into a form that can jump from human to human.

But they warned that it could take five years or longer to convert their discovery of a potential weak point in the N1 part of the virus into an effective drug.

So far the 238 cases of human infection have been from direct contact with infected birds, and scientists have said there is no evidence the virus is mutating towards making the leap between humans, though this could happen at any time.

Nearly 60 percent of those infected have died, and the best known drugs to tackle H5N1 infection in humans are oseltamivir known as Tamiflu and zanamivir known as Relenza, both originally developed to fight other forms of human 'flu. Now a team of scientists lead by John Skehel of London's National Institute of Medical Research say they have found a cavity in the N1 or neuraminidase part of the H5N1 virus that could be exploited as a potential weak point.

link to full article

Pfizer's Next Problem

Pfizer had a problem???...beyond my chloresterol medication going generic?...

Roche's competitor to Pfizer's much-anticipated "good cholesterol" pill torcetrapib may be more powerful than anyone thought, diluting the potential advantage for Pfizer's most important experimental drug.

Researchers who have seen data on the Roche drug say that it is far more potent when given with food, potentially complicating the gamble Pfizer has made on torcetrapib, which it is spending a record $800 million to develop.

Pfizer, the world's largest drug firm, is desperately in need of new firepower. Its $12 billion cholesterol pill Lipitor, the world's best-selling drug, is under siege from cheap generic copies of rival Zocor and the highly effective branded medicines Crestor and Vytorin. To make matters worse, an appeals court ruling just stripped a year of patent protection from Lipitor, meaning generics of the mega-blockbuster could be available in March 2010.

Torcetrapib is Lipitor's heir apparent. The drug is designed to boost high-density lipoprotein (HDL), nicknamed "good cholesterol" because it appears to actually clear plaque from the arteries and reduce the risk of heart attack.

In clinical studies alongside Lipitor, torcetrapib raised HDL by 60%. If everything goes as planned, a combination pill containing both torcetrapib and Lipitor will hit the market in the first half of 2008, and some analysts forecast 2009 sales of more than $1 billion. In a recent research note, analyst Barbara Ryan of Deutsche Bank called the drug "critical to Pfizer's future cash flows."

link to full article

Experimental RNA-Based Drug Kills Prostate Cancer Cells Effectively and Safely

I keep waiting for the breakthru, sort of like this...

DURHAM, N.C. -- Acting as a genetic Trojan horse, an experimental RNA-based drug -- the first of its kind -- tricks its way into prostate cancer cells and then springs into action to destroy them, while leaving normal cells unharmed.

The drug, developed at Duke University Medical Center, uses one type of genetic material, called targeting RNA, to enter cancer cells, and another type, called silencing RNA, to stop the expression of a protein that keeps the cells alive.

In tests in mice with prostate cancer, the drug shrank the size of their tumors by half, while the tumors in control mice that did not receive the drug continued to grow, said study co-author Bruce Sullenger, Ph.D., director of Duke's Translational Research Institute and chief of the Division of Experimental Surgery.

The mice showed no side effects from the treatment, Sullenger said.

"This study represents the first step in creating an RNA-based drug for cancer," said lead author James McNamara, Ph.D. a postdoctoral fellow in experimental surgery. "It provides a 'proof of principle' that an entirely RNA-based drug can work with minimal side effects, and it shows it is possible to overcome many of the obstacles that have hampered the development of RNA-based drugs."

link to full article

Bill and Melinda- Fund's $500M targets diseases

I haven't seen this info in any US new outlets...

TORONTO -- The battle against three diseases that are a scourge of sub-Saharan Africa and other developing regions -- HIV/AIDS, tuberculosis and malaria -- got a $500-million US boost from the Bill & Melinda Gates Foundation.

The couple will give the cash over five years to the Global Fund to Fight AIDS, Tuberculosis and Malaria.

"The Global Fund is one of the most important health initiatives in the world today," Bill Gates said in a statement announcing the gift ahead of the 16th International AIDS Conference in Toronto that starts Sunday.

Providing antiretroviral drugs to people infected with HIV/AIDS is a major feature of the fund's work.

Gates Foundation

update

link to full article

Vaccine slows hunger hormone, keeps rats slim

There may be hope for me after all...

WASHINGTON (Reuters) - A vaccine that slows down a key hunger hormone kept rats from gaining weight, even when they over ate, U.S. researchers reported on Monday.

The team at The Scripps Research Institute in California cautioned that such a vaccine is a long way from being tested in human volunteers, and that it may not work in people.

But the study shed light on how hunger and weight gain work, they reported in this week's issue of the Proceedings of the National Academy of Sciences.

The vaccine targeted ghrelin, a hormone discovered in 1999 that helps control appetite in animals and people.


"It appears that active vaccination against ghrelin is one avenue that can slow weight gain and fat build-up in the body," said Kim Janda, a chemistry professor who helped direct the study.

link to full article

Biotech investing surges in Philly

From the Biotech Weblog

Venture investment surges in the Philadelphia region

This article from Philly.com higlights the increase in life science venture capital investing in the Philadelphia region.

Link to blog article

GlaxoSmithKline (GSK) Reports Significant Advance In H5N1 Pandemic Flu Vaccine Program

PHILADELPHIA, July 26, 2006 /PRNewswire-FirstCall/ -- GlaxoSmithKline plc today announced headline data showing that its H5N1 pandemic flu vaccine achieved a high immune response at a low dose of antigen. The vaccine, which uses a proprietary adjuvant, enabled over 80% of subjects who received 3.8 micrograms of antigen to demonstrate a strong seroprotective immune response. This level of seroprotection meets or exceeds target criteria set by regulatory agencies for registration of influenza vaccines. Efficacy results at these levels of antigen dosage have also not been reported for any other H5N1 vaccine in development to date, including those using other adjuvants such as alum.

Commenting on the data, JP Garnier, GlaxoSmithKline's Chief Executive Officer, said: "These excellent clinical trial results represent a significant breakthrough in the development of our pandemic flu vaccine. This is the first time such a low dose of H5N1 antigen has been able to stimulate this level of strong immune response.

"There is still a lot more work to be done with this program, but this validation of our approach provides us with the confidence to continue developing the vaccine, including assessment of its ability to offer cross-protection to variants of the H5N1 strain. All being well, we expect to make regulatory filings for the vaccine in the coming months."

link to full article

Proteins Hold Clues to Chronic Pain

maybe this is why my knees hurt all the time...

WEDNESDAY, July 26 (HealthDay News) -- Low blood levels of two anti-inflammatory proteins could be key to chronic pain, researchers report.

Low concentrations of two cytokines, IL-4 and IL-10, were found in patients with chronic widespread pain, according to a German study published in the August issue of Arthritis & Rheumatism.

Cytokines are proteins that act as messengers between cells.

The study included 40 patients who'd received intravenous immunoglobulin (IVIG) as a novel treatment for pain that hadn't responded to standard therapy and another 15 patients who did not receive IVIG. The study also included a control group of 40 healthy people.

Blood samples were collected from all the study volunteers, and the pain patients were asked to rate their pain, fatigue, mood and cognitive function.

Compared with the control group, the 40 pain patients had significantly lower levels of IL-4 and IL-10. The 15 patients in the second group had similar results, although the difference in their levels of IL-10 compared to people in the control group was not statistically significant.

Several factors may be involved in low levels of these cytokines and how they influence pain, the study authors said. They noted that previous studies have shown that IL-10 reduces sensitivity to pain and that IL-4 can also dull pain response.

Genetic variations in different cytokine genes are associated with certain diseases. For example, IL-4 gene variations are associated with asthma, Crohn's disease and chronic polyarthritis, the researchers said.

"The low levels of IL-4 and IL-10 we observed in the patients with chronic widespread pain might therefore also be caused by genetic alterations either in the cytokine genes themselves or in regulatory elements, although other factors may be involved," they explained.

link to full article

Fat stem cells turn into muscle in experiment

now we're talking...

now if we could just get fat cells to turn into gasoline...

WASHINGTON (Reuters) - Stem cells taken from human fat can be transformed into smooth muscle cells, offering a way to treat many kinds of heart disease, gastrointestinal and bladder ills, U.S. researchers reported on Monday.

While the experiment does not quite offer a way to turn a pot belly into a flat stomach, the researchers said the transformed cells contracted and relaxed just like smooth muscle cells.

These cells help the heart beat and blood flow, push food through the digestive system and make bladders fill and empty, the researchers reported.


Their study, published in the Proceedings of the National Academy of Sciences, is the latest to show that fat can be a rich source of the body's master cells.

"Fat tissue may prove a reliable source of smooth muscle cells that we can use to regenerate and repair damaged organs," said Dr. Larissa Rodriguez, an assistant professor in the Department of Urology at the University of California Los Angeles medical school.

And almost any American has plenty of spare fat cells.

link to full article

Another marketing executive is leaving Merck

Another top marketing executive has left Merck & Co. Inc., part of a management shake-up under chief executive officer Richard T. Clark's plan to revive the pharmaceutical firm.

Per Wold-Olsen, 58, a 30-year veteran of Merck, "has informed us of his decision to retire" as president of Merck Human Health Intercontinental, the company confirmed yesterday. He will be succeeded by Stefan Oschmann as president of Merck's European and Canadian marketing subdivision.

Last week, Bradley T. Sheares, 49, president of U.S. Human Health, based in Upper Gwynedd, Montgomery County, was replaced by Adam Schechter, current general manager of Merck's joint venture with Schering-Plough Corp. Sheares left to "pursue other opportunities," the company said.

The departures affect two of the top three executives at Merck Human Health, its prescription-drug division and biggest revenue producer. David Anstice, former chief of the division, remains at Merck as president of Human Health Asia-Pacific. He is also a key defense witness at Merck trials over the pain-reliever Vioxx.

The shake-up was expected to continue, perhaps including sales managers and sales representatives, according to Wall Street analysts and others knowledgeable about Merck's plans. It comes two months after Clark installed a new president of Global Human Health, Peter Loescher, over Olsen, Sheares and Anstice as part of a restructuring triggered largely by the Vioxx recall and litigation.

link to full article

California to lend stem-cell center up to $150 mln

SAN FRANCISCO (Reuters) - California Gov. Arnold Schwarzenegger moved on Thursday to provide his state's voter approved stem-cell research institute with a loan of up to $150 million.

The governor's decision came after President George W. Bush vetoed a bill to expand federal funding of embryonic stem-cell research.

The loan will come from California's general fund and will support grants for medical research involving stem cells, which many researchers believe can be used to develop treatments and cures for various diseases, including Alzheimer's disease.


"We anticipate a couple of months at most before the money would go out the door," said H.D. Palmer, a spokesman for California's Department of Finance.

The money will help the California Institute for Regenerative Medicine fund initial research grants.

link to full article

stem cell research

350 New Jobs Planned For Novartis Vaccines and Diagnostics

and North Carolina wins it?...

Gov. Mike Easley announced Tuesday that Novartis Vaccines and Diagnostics will build and operate an influenza vaccines manufacturing plant with 350 new jobs and invest a minimum $267.5 million over the next five years in Wake County. The announcement was made possible in part by the One North Carolina Fund and the Job Development Investment Grant.

still looking for the story link...

link to previous post

Maryland fails to seduce Novartis

Senate passes stem cell measure despite Bush veto threat

"The politics of dancing..."

- UPDATE-

Bush vetoes stem cell bill as promised

WASHINGTON - President Bush cast the first veto of his presidency Wednesday, saying legislation easing limits on federal funding for embryonic stem cell research "crosses a moral boundary."

link to full article


WASHINGTON (AFP) -President George W. Bush is expected to use his power of veto for the first time since he took office to stop the US Congress from expanding funding for stem cell research.

The president "believes strongly that for the purpose of research it's inappropriate for the federal government to finance something that many people consider murder," White House spokesman Tony Snow said before a controversial Senate vote on Tuesday.

The Stem Cell Research Enhancement Act would lift rules Bush set in 2001 that make federal funds available only for research on a small number of embryonic stem cell lines which existed at that time.

Government money was barred from supporting work on new lines derived from human embryos -- a restriction that opponents say hampers overall research. They say that some of the stem-cell lines approved under the 2001 legislation are unusable.

Stem cell research advocates say the technique shows promise for the treatment of degenerative diseases such as Alzheimer's and Parkinson's, and for diabetes.

Opponents say the destruction of human embryos is morally wrong.

link to full article

Using Tobacco To Fight Cancer: Scientists Engineer Tobacco-Made Antibodies Targeting Cancer Cells

When virologist Hilary Koprowski, M.D., reported last month in the Proceedings of the National Academy of Sciences how he and colleagues used tobacco plants to produce cancer-fighting monoclonal antibodies that recognize and hunt down breast and colorectal cancer cells, the work represented another step toward a goal he has been pursuing for the last decade.

While therapeutic uses for such antibodies continue to grow at a rapid rate, production has failed to keep pace. Dr. Koprowski, professor of cancer biology at Jefferson Medical College of Thomas Jefferson University and Jefferson’s Kimmel Cancer Center in Philadelphia, contends that “plants are safer, less expensive and easier to use” than currently used methods in the laboratory and with animals. For mass production purposes, he says, “plants make more sense.”

link to full article

Maryland fails to seduce Novartis

12/07/2006 - Maryland is no longer in the running for a $500m (€392m) vaccine manufacturing plant Novartis is seeking to build in the US, as speculation about which state will host America’s first cell culture-derived influenza vaccine plant is reaching fever pitch.

The state had been in the running with North Carolina and Georgia for the Swiss company's plant, offering incentives to convince Novartis to make the investment, according to the Baltimore Business Journal.
But Aris Melissaratos, Maryland's secretary of the Department of Business and Economic Development, has now been reported by the Washington Business Journal as saying that other states were willing to give away free land and so Maryland couldn't compete with that incentive given this region's high real estate prices.

Asked by In-PharmaTechnologist.com what criteria the drugmaker is using for the selection, a Novartis spokeswoman cited the availability of an educated workforce and the proximity to other company locations as key requirements.

The facility has attracted great interest because it will be the first US-based vaccine manufacturing facility using biotechnology cell cultures rather than chicken eggs for primary production.

Current egg-derived vaccines production requires several months of logistics for ordering and receiving eggs, so this lead time can hinder the response to unanticipated demands such as the discovery of pandemic strains, production failures and seasonal influenza virus strain changes.

link to full article

vaccine manufacturing

FDA says open to more flexible clinical trials

WASHINGTON (Reuters) - U.S. regulators are preparing guidelines telling drug makers how they can streamline the testing of experimental medicines by conducting more flexible clinical trials, a top official said on Monday.

The Food and Drug Administration wants to encourage "adaptive" clinical trials that change mid-way through, said Dr. Scott Gottlieb, deputy FDA commissioner for medical and scientific affairs.

The approach is a departure from the rigid structure of most drug studies required for FDA approval in which companies, patients and physicians do not know results until the research is completed. Such "blinding" is usually mandated to keep doctors or patients from acting in a way that could affect a study's outcome.

link to full article

Killer tomatoes attack human diseases

Those crazy Russians are at it again...

here's hoping it works...

GENETICALLY modified tomatoes containing edible vaccine are to be used to challenge two of the world's most lethal viruses.

The aim is to create affordable vaccines for HIV and the hepatitis B virus (HBV) that could be easily grown and processed in the countries where they are most needed. So far, none of the 90 or so potential vaccines against HIV have proved successful and, though a vaccine already exists for HBV, it is too expensive to be used by poorer countries.

Rurik Salyaev at the Siberian Institute of Plant Physiology and Biochemistry in Irkutsk, Russia, and his colleagues used the soil bacterium Agrobacterium tumefaciens to shuttle a synthetic combination of HIV and HBV DNA fragments into tomato plants. These include fragments of genes for various HIV proteins and the gene for an HBV protein called HBV surface antigen.

The tomato plants then manufacture the proteins and, like the oral polio vaccine, when the tomatoes are eaten, these proteins prompt the body to create antibodies against the viruses.

link to full article

Disgraced SKorean cloning expert plans to resume research

SEOUL (AFP) - South Korea's disgraced cloning expert Hwang Woo-Suk, on trial over charges of fraud and embezzlement, will resume research work as early as next month, his laywer has said.

"Dr. Hwang will resume his research next month. He will set up a private lab somewhere in Seoul," his defence lawyer Lee Geon-Haeng told AFP. "Some donors will provide funds for him to restart his study."

About 30 of his former assistants will join the new lab but Hwang's top two lieutenants, including Lee Byeong-Chun who is credited with creating the world's first cloned dog last year, will not join the team.

Hwang will focus on animal cloning experiments because he was deprived of a government license for human stem cell research in March, a month after experts concluded that his landmark research papers were bogus.


link to full article

Bill Gates To End Regular Duties At Microsoft By July 2008

Did you ever think the computer/ tech industry would impact the pharmaceutical market like this?

Devote Full-Time Efforts To Gates Foundation

Update: Warren Buffett gives away his fortune

Bill Gates on Thursday announced plans to relinquish over the next two years all daily work duties at Microsoft, the company he founded, and work fulltime for the Bill & Melinda Gates Foundation, which to date has spent more than $10 billion on programs to fight HIV/AIDS and other global health concerns and reform education, the Los Angeles Times reports (Gaither/Yue Jones, Los Angeles Times, 6/16). Melinda and Bill Gates and Irish musician Bono in December 2005 were named TIME magazine's "Persons of the Year" for their efforts to improve global health and eradicate poverty. The Gates Foundation has an endowment of $29 billion (Kaiser Daily HIV/AIDS Report, 12/19/05). According to the Times, the foundation's spending "rivals" that of the World Health Organization (Los Angeles Times, 6/16). The Gates Foundation accounts for more than half of worldwide spending, about $159 million, on research and treatment for diseases such as tuberculosis and malaria. "With success, I have been given great wealth," Bill Gates said, adding, "And with great wealth comes great responsibility to give back to society, to see that those resources are put to work in the best possible way to help those in need" (Kehaulani Goo, Washington Post, 6/16). Bill Gates will remain chair of Microsoft and have the title of "senior technical adviser" after the transition is complete (Keefe, Cox/Atlanta Journal-Constitution, 6/16).

link to full article

Gene called "Nanog" could be key to master cells

LONDON (Reuters) - A gene named after the mythical Celtic land of the ever young could help explain how to reprogram adult cells into embryonic stem cells to treat diseases, researchers said on Wednesday.

They discovered that the gene called Nanog helped to transform adult mouse cells into embryonic stem cells after cell fusion -- when two cells are combined to form a hybrid.

"The effect of Nanog is remarkable. All the hybrid cells became fully converted to embryonic stem cells," said Dr Jose Silva of the University of Edinburgh, Scotland, who reported the findings in the journal Nature.


Stem cells are master cells in the body. Scientists believe they could act as type of human repair system to provide new therapies for illnesses ranging from diabetes to Parkinson's.

Embryonic stem cells found in early embryos have the potential to make any type of cell or tissue. Adult stem cells have a more limited range.

link to full article

Sandoz approval could open the floodgates for biosimilars in US

let's get some floodgates open...even if it takes using the word "biosimilar"...

06/06/2006 - German biopharma firm Sandoz has won a landmark first-of its-kind biosimilar drug approval in the US after a long battle with the US Food and Drug Administration (FDA). The decision could open the floodgates for generics manufacturers in this lucrative market.

Following the green light for Sandoz's copycat biologic growth hormone drug, Omnitrope, the company is now ramping up manufacturing at its fermentation plant in Kundl, Austria and expects to have the drug on the US market by the end of the year.
Omnitrope was approved in Europe in April by the European Commission and is already on the market in Germany, with launches planned in further European countries later this year. The drug was also launched in Australia in November last year.

According to the FDA Omnitrope is not officially called a generic because it is not rated as therapeutically equivalent to any of the other approved human growth hormone (hGH) products. It is however “sufficiently similar” to a product already approved and is thus given the term "follow-on protein product." In Europe the preferred term is ‘biosimilar'.

link to full article

biogeneric

biosimilar

Harvard makes ambitious life sciences gamble

some more people who see biotech as the new economic engine...

Harvard, no less...

CAMBRIDGE, Mass (Reuters) - As Harvard University searches for a new leader, questions loom over its last president's most ambitious project: turning America's oldest university into the nation's hub for life sciences.

During his 5-year tenure as the university's president, former U.S. Treasury Secretary Lawrence Summers worked to put Harvard at the forefront of research on how the human cell works, a question the school's founders and the Massachusetts Bay Colony's Puritan leaders would have kept in the province of religion alone.

Nearly four centuries later, Harvard's plans -- which include building a new campus of buildings -- fit well with Massachusetts' desire to rejuvenate its economy by encouraging biotechnology firms to replace the region's long-fading manufacturing base.

"For Boston to survive (it) is by being on the cutting edge of new ideas and technology," said Harvard economics professor Edward Glaeser, who is also director of the Rappaport Institute for Greater Boston, a research group. "And the vision Larry Summers has for Harvard is that it would play a major role in the life sciences and not sit this one out."

link to full article

biotechnology

United States seen lagging on stem cell research

LONDON (Reuters) - The United States is lagging behind Britain and other leading nations on stem cell research, a visiting U.S. Congressional delegation said on Thursday.

Scientists believe that stem cells, master cells in the body that can develop into any cell type, could be used to treat diseases ranging from diabetes to Parkinson's.

But their use is controversial because the most promising stem cells for treating human diseases are derived from very early human embryos.

The United has restricted federal funding of stem cell research which Colorado Democrat Rep. Diana DeGette said has forced some American scientists to relocate to countries which have more lenient policies.


"In addition, leadership in this area of research has shifted to the United Kingdom, which sees this scientific area as a cornerstone of its biotech industry," she said in a statement.

link to full article

stem cell research

Hillary rips climbers who left dying man

There is a book called "Into Thin Air" about climbing Everest. It was once given out as a parting gift from the Project Manager on a particularly challenging project.

I can recommend the book as a gripping account of a human drama gone horribly wrong,...as a metaphor for a project, not so much...

WELLINGTON, New Zealand - Mount Everest pioneer Sir Edmund Hillary said Wednesday he was shocked that dozens of climbers left a British mountaineer to die during their own attempts on the world's tallest peak.

David Sharp, 34, died apparently of oxygen deficiency while descending from the summit during a solo climb last week.

More than 40 climbers are thought to have seen him as he lay dying, and almost all continued to the summit without offering assistance.

"Human life is far more important than just getting to the top of a mountain," Hillary was quoted as saying in an interview with New Zealand Press Association.

link to full article

Fake Chinese drug kills nine

this doesn't sound good...I didn't know this was an on-going problem...

BEIJING (Reuters) - Nine people have died after being injected with a fake drug made by a Chinese company and 14 executives have been detained for questioning, state media said on Monday.

The victims died after being injected with fake Armillarisni A, made by the Qiqihar No. 2 Pharmaceutical Co. Ltd., based in northeastern Heilongjiang province, Xinhua news agency quoted hospital sources as saying.

The nine died in the southern city of Guangzhou, Xinhua said.

Police had taken five of the detained executives to Guangzhou for questioning, the China Daily said.

The drug is used to treat gall bladder, liver and gastric disorders.

The consumption of fake and inferior quality products has claimed dozens of lives in China in recent years.

A major health scandal erupted in 2004 after China revealed that at least 13 babies had died of malnutrition in the country's eastern province of Anhui after being fed fake baby milk.

link to full article

Testing for Bird Flu Begins in Alaska

Alaska?

ANCHORAGE, Alaska - Federal scientists have started testing migratory birds for signs of a dangerous bird flu that could show up on this continent this spring.

The testing of shorebirds began Wednesday on an Anchorage coastal wildlife refuge, said Bruce Woods, spokesman with the U.S. Fish and Wildlife Service.

It's the first sampling of a summer-long project to swab birds for bird flu throughout the state. Nationwide, the goal is to sample 75,000 to 100,000 wild birds. In Alaska, about $4 million in federal money will be allocated to study about 15,000 birds, Woods said.

link to full article

bird flu

For-Profit Funding May Bias Clinical Trials

TUESDAY, May 16 (HealthDay News) -- In a revealing look at the impact of funding on medical research, a new study found that clinical trials funded by drug companies and other for-profit entities were more likely to report positive findings than similar trials funded by nonprofit groups.

Trials that were jointly funded by for-profit and non-profit organizations had positive findings that fell about midway between the rates observed for either extreme.

"I'm not surprised that that is the case," said Adil Shamoo, a professor of biochemistry and bioethics at the University of Maryland, Baltimore, and co-founder of Citizens for Responsible Care and Research, which lobbies for the rights of patients and clinical trial participants.

link to full article

Scientists Create the First Synthetic Nanoscale Fractal Molecule

I keep waiting for this nanotech stuff to break wide open...especially the bio-nanotech developments...

ATHENS, Ohio – From snowflakes to the leaves on a tree, objects in nature are made of irregular molecules called fractals. Scientists now have created and captured an image of the largest man-made fractal molecule at the nanoscale.

The molecule, developed by researchers at the University of Akron, Ohio University and Clemson University, eventually could lead to new types of photoelectric cells, molecular batteries and energy storage, according to the scientists, whose study was published online today by the journal Science.

A University of Akron research team led by Vice President for Research George Newkome used molecular self-assembly techniques to synthesize the molecule in the laboratory. The molecule, bound with ions of iron and ruthenium, forms a hexagonal gasket.

Ohio University physicists Saw-Wai Hla and Violeta Iancu, who specialize in imaging objects at the nanoscale, confirmed the creation of the man-made fractal. To capture the image, the physicists sprayed the molecules onto a piece of gold, chilled them to minus 449 degrees Fahrenheit to keep them stable, and then viewed them with a scanning tunneling microscope.

Though invisible to the naked eye – the molecules are about one million times smaller than the colorful hexagons shown in the Science image – the objects are 12 nanometers wide. “That’s big for a nanoscale molecule. It’s huge,” said Hla, an associate professor of physics and astronomy.

“This man-made structure is one of the first nanoscale, non-branched fractal molecules ever produced,” said Newkome, who is lead author on the Science paper and also serves as dean of the Graduate School and the James and Vanita Oelschlager Professor of Science and Technology at the University of Akron. “Blending mathematics, art and science, these nanoscopic hexagonal-shaped materials can be self-assembled and resemble a fine bead necklace. These precise polymers — the first example of a molecule possessing a ‘Star of David’ motif — may provide an entrée into novel new types of photoelectric cells, molecular batteries and energy storage.”

link to full article

nanotechnology

Gabrieli proposes $1B in stem cells, biotech research

Politicians creating soundbites in Boston...

BOSTON --Democratic gubernatorial hopeful Chris Gabrieli proposed Thursday to make Massachusetts more competitive in the biotechnology industry by investing $1 billion in embryonic stem cell research and other life sciences.

Gabrieli said other states are poised to leap ahead of Massachusetts on stem cell research if funding isn't provided, and the state is losing the opportunity to create jobs the longer it waits to expand efforts into the life science field.

"With our hospitals and universities, we have no excuse not to lead the world in stem cell research," said Gabrieli, a venture capitalist.

link to full article

Disgraced stem cell scientist indicted for fraud

a bad situation going worse...

SEOUL (AFP) - South Korea's disgraced cloning expert Hwang Woo-Suk was indicted on fraud, embezzlement and ethical charges relating to his faked stem cell research, a senior prosecutor said.

Five other scientists were also indicted on charges in connection with the bogus research and the disappearance of millions of dollars in donations, prosecutor Lee In-Kyu told a press conference.

"Dr Hwang was indicted on charges of fraud and embezzlement and breach of bioethics. And five others were also indicted" on various charges, said Lee, announcing the conclusions of a five-month probe into Hwang's case.

The indictment means the end of a scientific career for Hwang, who was once referred to as South Korea's 'supreme scientist'. If convicted on all charges, Hwang could face up to five years in prison, legal experts said.

Hwang, 52, became a national hero last year when he claimed that he had created 11 patient-specific stem cells in landmark research on cloning.

link to full article

Chemists Get Electrons To 'Break On Through To The Other Side'

The connections between physics (electrons) and biology (cell processes) amaze me...

In the famous Robert Frost poem, "The Road Not Taken," the persona, forced to travel one of two roads, takes the one less traveled by, and "that has made all the difference."

Chemists at Washington University in St. Louis and Stanford University, in kinship with Frost, have modified a key protein in a bacterium to move electrons along a pathway not normally traveled by. They got this to happen 70 percent of the time. That yield "makes all the difference."

For years, scientists studying photosynthesis have noted that electrons in photosynthetic bacteria always choose one of two identical pathways of electron transport in the reaction center (RC) protein, which is the factory for photosynthesis. The electrons always go to one pigment , sometimes called the "right" side, shunning the left. The molecule-to-molecule movement of electrons stimulated by sunlight is called charge separation. It's the basic modus operandi of photosynthesis, whereby plants and some bacteria use sunlight to produce chemical energy. The reaction center protein is like a forest with two roads. The chemists got the electrons to take the path not traveled.

link to full article

link to ScienceDaily home page

US awards $1 billion in flu vaccine contracts

Guess who's going to be busy in the flu business...

WASHINGTON (Reuters) - Five companies were awarded more than $1 billion in contracts to develop new and better influenza vaccines, the U.S. Health and Human Services Department said on Thursday.

The companies will all work to develop cell based-vaccines to fight influenza, Health and Human Services Secretary Mike Leavitt said.

GlaxoSmithKline Plc (GSK.L) (NYSE:GSK - news) was awarded $274.75 million, MedImmune Inc. (Nasdaq:MEDI - news) was awarded $169.46 million, Novartis AG (NOVN.VX) won $220.51 million, DynPort vaccine, working with Baxter International Inc. (NYSE:BAX - news), won $40.97 million and Solvay (SOLBt.BR) won $298.59 million.

link to full article

Former FDA commissioner investigated

It appears that the former commissioner of the Food and Drug Administration Dr. Lester Crawford is under federal investigation amid accusations of financial improprieties and making false statements to Congress.
Crawford's attorney Barbara Van Gelder, says a grand jury has begun a criminal investigation into the activities of Lester Crawford when he was head of the FDA, but made no further comment.

Van Gelder has apparently instructed Crawford to invoke his Fifth Amendment right against self-incrimination if ordered to answer questions.

Dr. Crawford resigned last September two months after being confirmed for the job.

He had been acting commissioner for more than a year and said then it was time for someone else to take over the job.

It has been disclosed that either Crawford, or his wife, according to documents released by the Dept of Health and Human Services, had sold shares for more than $50,000 in companies which the FDA regulates when he was FDA's Deputy Commissioner and Acting Commissioner.

Following his abrupt resignation Crawford went to work for Policy Directions Inc., a lobbying firm.

The criminal investigation came to light at a court hearing in a lawsuit over the FDA's actions on the emergency contraceptive pills, a subject of heated debate during Crawford's time at the FDA.

link to full article

Mild form of avian flu found in New Jersey

UPDATE 02May06

Bird Flu Strain Found In Camden Market

TRENTON, N.J. -- A form of the avian flu has been found in a live bird market in Camden.

That is according to New Jersey's Agriculture Secretary, Charles Kuperus.

In a statement, Kuperussaid the bird flu strain cannot harm humans and is not pathogenic.

link to full article


This was reported on last nights local news as happening in a live bird market in Camden, NJ...I live 2 towns away...

anywho, who knew they had a live bird market?


NEW YORK (Reuters) - Authorities have discovered a mild form of avian influenza at a live bird market in New Jersey, but it is not the deadly H5N1 strain governments around the world are trying to contain, the state's agriculture department said.

"The strain was found in a live bird market in Camden County. None of the birds in the market died from this virus, which is an indicator that the virus was low pathogenic and not harmful to humans," said a statement by New Jersey's Agriculture Secretary Charles Kuperus which was posted on Friday.

Details were not immediately available on precisely when the avian flu in Camden County was discovered.

link to full article

Bird Flu

New way to treat obesity heralded

looks like the new blockbuster has been identified...

Topping up levels of a hormone found naturally in the stomach could be a new way to treat obesity.
Boosting oxyntomodulin limits appetite and raises activity levels at the same time - leading to speedy but healthy weight loss rates, a UK study suggests.

The hormone tells us we are full after a meal, but the obese have less of it.

The fact dieting tends to lead to reductions in activity often makes weight loss harder, the International Journal of Obesity study says.

Professor Steve Bloom head of the Division of Investigative Science at Imperial College London said earlier studies had shown oxyntomodulin decreased appetite.

link to full article

US drug pacts keep some generics off market: FTC

WASHINGTON (Reuters) - Brand-name drug makers are striking more deals with generic rivals to restrict the introduction of cheaper generic drugs, U.S. antitrust authorities said on Monday.

Emboldened by recent victories in court, pharmaceutical companies are using controversial settlements that entail payments to generic rivals which promise to restrict selling competing generic drugs, a Federal Trade Commission official said in a speech on Monday.

"We are seeing far more settlements today that potentially raise competition concerns," FTC Commissioner Jon Leibowitz said in prepared remarks for a Philadelphia business group.

Leibowitz's comments came on the same day the FTC released a report on patent settlements among drug companies.

The FTC has filed lawsuits in recent years challenging patent settlement agreements between major drugmakers and their generic rivals. In some cases, the FTC contends the settlements stifle competition because drugmakers are paying generics to stay out of the market.

Generic drugs are typically cheaper for consumers to buy than brand-name drugs.


link to full article

Report questions FDA's safety procedures

Wha? Wha? What???...

great quote at the bottom of the article...trying for a sound bite, I guess...

The Food and Drug Administration "lacks a clear and effective process" for managing postmarket drug safety issues, says a Government Accountability Office report out Monday. The report was requested in late 2004 by Sen. Charles Grassley, R-Iowa, chair of the Senate Finance Committee, and Rep. Joe Barton, R-Texas, chair of the House Energy and Commerce Committee.

Concerns about how the FDA handled high-profile drug safety cases — two were Vioxx, the painkiller linked to heart attacks and strokes, and antidepressants, linked to suicidal behavior in children — spurred the request.

"GAO observed that there is a lack of criteria for determining what safety actions to take and when to take them," the report states, noting that FDA officials, given a chance to review a draft, called its conclusions "reasonable" but did not comment on its recommendations.

In an interview Friday, Grassley said the report backs up "what everybody seems to know, that the FDA needs reform, that things that go on in the FDA don't really protect the consumer. The FDA is kind of a Good Housekeeping seal of approval on drugs, and really, it's questionable (whether) they should have that honor."

In a statement, Barton said the GAO "shows that the drug-safety system is not in crisis, but the FDA's process may need some fine-tuning. Prescription drugs approved by the FDA should keep you out of the hospital, not send you to one."


link to full artcile

Just eat less...

just like my cardiologist says...

"Losing weight basically boils down to burning more calories than you take in."

NEW YORK (Reuters Health) - A brisk walk through the park might be better than a fast run when it comes to shedding pounds, a small study suggests.

Researchers found that among 14 women who embarked on a three-month exercise regimen, those who worked out at a moderate pace lost more weight than those who exercised more intensively.

But it's not time for runners to start slowing down, according to the study authors. For one, women in the higher-intensity exercise group did retain more muscle mass than those who worked out more moderately.


More importantly, though, there is no such thing as one "magic exercise," said lead study author Dr. Vassilis Mougios of Aristotle University of Thessaloniki in Greece.

To get the greatest health and fitness benefits, he told Reuters Health, people should strive for a mix of moderate and vigorous cardiovascular exercise, as well as strength training.

Mougios and his colleagues report their findings in the International Journal of Sports Medicine.

Losing weight basically boils down to burning more calories than you take in. But it hasn't been clear whether the intensity of a regular workout makes a difference in body composition - that is, the proportions of fat and lean tissue.


link to full article...

Another Virtual Neighbor...

interesting story regarding big pharma versus biotech...

link

this blog is called the Pharma Marketing Blog

FDA backlog = Billions for Big Pharma?

A bottleneck of generic drug applications may give branded drugs more time on the market without generic competition.

good thing if you own big pharma stock...

NEW YORK (CNNMoney.com) - Big Pharma could land billions of dollars in annual sales that it would have lost to generic competitors thanks to a Food and Drug Administration backlog of applications for generic drugs.

Some $100 billion worth of branded drugs are expected to go off patent over the next five years. In theory, this should translate into lost revenue for branded drug companies because they would face a plunge in sales as they compete with low-cost generic versions of their drugs.

But the FDA's Office of Generic Drugs, which reviews applications for generic drugs, faces a bottleneck of some 800 applications. This is the result of a 36 percent surge in applications last year, according to the Generic Pharmaceutical Association, citing statements made by Gary Buehler, director of the Office of Generic Drugs, at a GPhA conference in February.

"Over the next few years, it's really going to be a problem, as more drugs go off patent," said GPhA spokeswoman Andrea Hofelich.

link to full article

And the next Pfizer CEO is...

Filling the leadership void...

Three ambitious executives are vying to succeed CEO Hank McKinnell...

NEW YORK (FORTUNE) - If only the rest of Big Pharma were as lucky as Pfizer. In the midst of what most top-level managers agree is a CEO talent drought, the New York-based pharma-colossus has no less than three potential CEOs vying to take over when current top guy Hank McKinnell retires in 2008. But there are quite a few sharp elbows being thrown in the race to the top.

Last year, Pfizer (Research) CEO Hank McKinnell promoted three ambitious top executives -- Karen Katen, head of sales and marketing, Jeff Kindler, general counsel and David Shedlarz, chief financial officer -- expanding their responsibilities and bestowing each with a vice chairmanship. The race was on. And one of them will emerge as the 13th CEO in Pfizer's 157-year history.

Its stock is off 40 percent since 2001. Profits are down. CEO Hank McKinnell's to-do list? Create hit drugs, pick a successor and convince Wall Street he can make all the company's pieces fit together.

Katen and Shedlarz appear to be working nicely together. Last year, they were given the onerous task of cutting $4 billion in annual costs by 2008. Less than a year into the project, they have already achieved more than $800 million in savings, well ahead of schedule.

But insiders claim their succession battle is creating factions, and distracting the company from its larger goals -- namely: becoming a growth company again. "There are David people and there are Karen people," says one insider of the two leading candidates. "And they're all pulling in different directions, trying to make their guy look good."

link to full article

Merck stock tumbles after Vioxx verdict

No. 2 U.S. drugmaker stung by loss in latest case over withdrawn painkiller; 10,000 more suits loom.

NEW YORK (CNNMoney.com) - Merck stock tumbled Thursday, a day after the nation's No. 2 drugmaker was found liable for the heart attack of a New Jersey man who took Vioxx and a jury awarded $4.5 million in damages.

Merck (Research) stock sank about 4 percent in morning New York Stock Exchange trading.

A jury in Atlantic City, N.J., late Wednesday awarded John McDarby and his wife $4.5 million in compensatory damages in their suit against Merck. But in a split verdict, Tom Cona, the second plaintiff in the case, received virtually no award. Both men had blamed their non-fatal heart attacks on the arthritis painkiller.

Merck has won verdicts in two trials and has been liable in two others. The drugmaker, based in Whitehouse Station, N.J., still faces about 10,000 lawsuits from plaintiffs who blame the arthritis painkiller Vioxx for their heart attacks. Merck pulled Vioxx off the market on Sept. 30, 2004 after a study demonstrated that the drug increased the risk of heart attacks and strokes.

Despite the knee-jerk drop in stock price following Wednesday's verdict, some analysts said that possible liability of up to $30 billion has been priced into the stock, and that Merck shares should eventually recover.

link to full article

LRIG Philadelphia Chapter

more virtual neighbors...

LRIG Philadelphia Chapter

hosting events

I'll try to get some feedback...

check the amusing (sort of) background story here

I'll be working on some more links to other organizations shortly...

One big biology question solved

just in case you were ever wondering...

An Australian research team has solved one of biology's most fundamental questions – why males produce sperm and females produce eggs. The finding is a breakthrough that could lead to improved infertility treatment, cancer therapy and pest management.
The team, led by Dr Josephine Bowles and Professor Peter Koopman from the Institute for Molecular Bioscience at The University of Queensland, has discovered that derivatives of Vitamin A trigger the beginning of egg and sperm production, a process known as meiosis.

The cells that eventually turn into either eggs or sperm – known as germ cells – are identical in male and female embryos.

"Whether a germ cell develops into an egg or a sperm depends on the time at which meiosis begins," Professor Koopman said.

"In females, meiosis begins before birth and eggs are produced, whereas in males, meiosis begins after birth and the result is sperm."

Professor Koopman and his team found that retinoic acid, a derivative of Vitamin A, causes germ cells in female embryos to begin meiosis, leading to the production of eggs.

They also discovered an enzyme present in male embryos that wipes out retinoic acid and so suppresses meiosis until after birth, resulting in sperm production.

"This is an extremely important process that nobody has been able to figure out until now," Professor Koopman said.

"It is textbook science and it should provide the basis for a number of practical applications."


link to full article

Just when you thought that glass of wine did you good!

Oh No....

Just when you thought those one or two glasses of wine were of benefit to your health, a new study is now saying that is not necessarily the case.
According to researchers from Canada and Australia the benefits of alcohol for the heart are exaggerated.

Lead author Kaye M. Fillmore, Ph.D., of the University of California San Francisco School of Nursing and her team analyzed 54 previous studies on alcohol use and mortality, which included deaths from coronary heart disease.

Of the studies 47 included in the "abstainer" category individuals who were not long-term abstainers but had only recently stopped drinking or cut down to once per month or less, says Fillmore.

The studies were published in the 1980s and 1990s, although they spanned 1950 to 2004 and the researchers found a systematic error in the design of previous studies that may have exaggerated alcohol as a health boon.

The studies in the main divided groups into "drinkers" and "abstainers" and among the abstainers were people who had reduced or quit drinking for medical reasons.

The researchers say the abstainers had higher death rates than drinkers.

Initially it appeared the abstainers were at higher risk for heart disease because they refrained from drinking alcohol, and so did not get its protective benefit, when in fact Fillmore says those in the abstainer category were often already frail and predisposed to death.

link to full article

Blogging Interphex 2006

Well, what happened to my plan...

I didn't even make it to Interphex this year, let alone blog about it...too busy with my existing Client, too busy looking for a new Client...

I had planned on doing a yearly blog for the big events, Interphex, ISPE, etc. etc. It would be good for the blog, keep it active, keep it current...and then I had to choose...

What is more important? blogging...a good strategic move...
or servicing Clients and finding new work...that may be even more strategic

for better or worse, I choose work...I gues I'll Blog Interphex 2007 instead...

Mouse Testicle Cells Behave Like Stem Cells

Progress of sorts...

NEW YORK - German scientists say cells from the testes of mice can behave like embryonic stem cells. If the same holds true in humans, it could provide a controversy-free source of versatile cells for use in treating disease.

Embryonic stem cells can give rise to virtually any tissue in the body and scientists believe they may offer treatments for diseases like Parkinson's and diabetes and spinal cord injuries.

But to harvest the cells, human embryos must be destroyed. Some religious groups and others oppose that.

The new research into testicular cells, published online Friday by the journal Nature, comes from Dr. Gerd Hasenfuss of the Georg-August-University of Goettingen in Germany and colleagues.

Lab tests found that the mouse cells closely mimicked the behavior of embryonic stem cells, Hasenfuss said Friday. He said he is optimistic about finding human testicular cells that will do the same. Work has already begun on that, he said.

If such cells are found in men, "then we have resolved the ethical problem with human embryonic stem cells," he said in a telephone interview.

link to full article

Interphex

Well, it really snuck up on me this year...been much too busy...

Interphex

Facility of the Year won by Baxter with another modular project...

The Biotech Job Machine...

The job creation machine cranks onward...


on the West Coast...

Indiana...

in St Louis...

and here in Jersey...

Stem Cell Center could be boost for Camden

A less active brain serotonin system is associated with early hardening of the arteries

A less active brain serotonin system is associated with early hardening of the arteries, according to a study presented by University of Pittsburgh researchers at the 64th Annual Scientific Conference of the American Psychosomatic Society in Denver.
These findings, which are the first to establish a link between serotonin messages in the brain and atherosclerosis, could lead to an entirely new strategy for preventing heart disease and stroke, say the researchers.

"Many of the known risk factors for heart disease and stroke - high blood pressure and cholesterol, obesity, diabetes, smoking and lack of exercise - can, to some extent, be controlled by our lifestyle choices," said Matthew F. Muldoon, M.D., M.P.H., associate professor of medicine, University of Pittsburgh School of Medicine. "Until now, no one had studied the possibility that brain abnormalities could explain why some people make these poor lifestyle choices and have multiple risk factors for heart disease."

link to full article

Students create plant that glows when thirsty

more cool gene technology stuff...

SINGAPORE (Reuters) - Some people like to talk to their plants. Now, students at Singapore Polytechnic say they have created a plant that can communicate with people -- by glowing when it needs water.

The students said on Tuesday that they have genetically modified a plant using a green fluorescent marker gene from jellyfish, so that it "lights up" when it is stressed as a result of dehydration.

The light is hard to detect with the naked eye but can be seen using an optical sensor developed in collaboration with students at Singapore's Nanyang Technological University.

The development of such plants could help farmers to develop more efficient irrigation of crops.

link to reuters article

Few Jobs Await Graduating Biotech Students

The job making machine appears to be broken in Florida...

meanwhile most every other state in the union is killing themselves to get biotech jobs lined up...

Mar. 4--Florida Atlantic University and Indian River Community College will jointly graduate their first class of biotechnology technicians in May under a special federal grant program.

But so far, there aren't any jobs for them.

Using a $2.3 million grant from the U.S. Department of Labor, FAU and the Workforce Alliance of Palm Beach County created a curriculum -- also adopted by IRCC -- to turn out lab techs for the biotech businesses expected to sprout as The Scripps Research Institute churns out drug research for commercialization.

But as the first 23 people complete the yearlong training and receive a certificate that says they are ready to work, the Workforce Alliance is struggling to find biotech positions for them.

An additional 17 will finish this summer or fall, and could face the same situation.

With the Palm Beach County Commission approving a site last month for Scripps Florida's headquarters at Abacoa in Jupiter and the adjacent Briger tract in Palm Beach Gardens, the hope is that biotech companies that have been on the fence will decide to move to Palm Beach, Martin or St. Lucie counties.

"Historically, when you have an anchor like Scripps, you have a huge spike in employment in four or five years," said Doug Saenz, a job developer with the Workforce Alliance. "We're confident that's going to happen."

But as is, the biotech cluster anticipated to surround Scripps hasn't started.


link to full article

Scientists capture the speediest ever motion in a molecule

Cool stuff...

The fastest ever observations of protons moving within a molecule open a new window on fundamental processes in chemistry and biology, researchers report today in the journal Science.
Their capturing of the movements of the lightest and therefore speediest components of a molecule will allow scientists to study molecular behaviour previously too fast to be detected. It gives a new in-depth understanding of how molecules behave in chemical processes, providing opportunities for greater study and control of molecules, including the organic molecules that are the building blocks of life.

The high speed at which protons can travel during chemical reactions means their motion needs to be measured in units of time called 'attoseconds', with one attosecond equating to one billion-billionth of a second. The team's observation of proton motion with an accuracy of 100 attoseconds in hydrogen and methane molecules is the fastest ever recorded. Dr John Tisch of Imperial College London says:

"Slicing up a second into intervals as miniscule as 100 attoseconds, as our new technique enables us to do, is extremely hard to conceptualise. It's like chopping up the 630 million kilometres from here to Jupiter into pieces as wide as a human hair."


link to full article

Beer extracts reported to have anti-inflammatory effect

Finally, research results we've been waiting for...

02/03/2006 - Extracts from any type of beer reduced inflammatory markers, say Austrian scientists who performed the in vitro experiments.

“On the basis of our new findings, beer must be added to the list of beverages with potentially anti-inflammatory components, but our findings must not be understood as an encouragement to drink alcohol,” said lead researcher Professor Dietmar Fuchs from Innsbruck Medical University.
The study, published in the journal International Immunopharmacology (Vol. 6, pp. 390-395) studies the effects of different beer extracts, including light beer, wheat beer, and non-alcoholic beer, on the production of neopterin (a marker for inflammation) and levels of tryptophan (the hormone – low levels are associated with more inflammation).

The scientists used peripheral blood mononuclear cells (PBMC) isolated from whole blood cells. Inflammation was stimulated using phytohaemagglutinin (PHA).

“Beer was found to suppress degradation of trypophan and production of neopterin in PMBC stimulated with PHA,” wrote Fuchs and his team.

link to full article

Calif. Stem Cell Agency Fights for Life

People actually fighting against the job delivery machine...

SAN FRANCISCO (AP) -- The future of embryonic stem cell research could be shaped in a suburban courtroom where two taxpayer groups are challenging the legality of California's new agency dedicated to the controversial field.

Opening statements were scheduled for Monday in a pair of lawsuits seeking to invalidate the law that created the California Institute of Regenerative Medicine, which is authorized to hand out $3 billion in research grants. The lawsuits allege - among other things - that it violates a state constitutional mandate that the spending of taxpayer dollars be under state control.

"The act delegates the disbursal of huge sums of public money to the unfettered discretion of an institution whose governing board and working groups are unaccountable to the public," one of the lawsuits said.

When voters created the institute in November 2004, stem cell scientists saw it as giving new traction to a field hamstrung by federal limitations on funding.

link to full AP article

New weight-loss drug backed in study

We all have high blood pressure
We all have high chloresteral

The next blockbuster...

We're all FAT!!!...


CHICAGO (Reuters) - An anti-obesity drug that turns off the same brain circuits which trigger the marijuana-induced munchies appears to produce sustained weight loss among patients who took it in a two-year study, researchers said on Tuesday.

The report by New York's Columbia University College of Physicians and Surgeons also said the drug -- Sanofi-Aventis SA's Acomplia, or rimonabant -- needs additional study for its long-term effects and said the research was limited by a high dropout rate. The drug company funded the study.

The drug is awaiting an approval decision by the U.S. Food and Drug Administration. However there has been speculation that it could become the world's first blockbuster anti-obesity medicine, with analysts estimating sales topping $3 billion a year.

link to full reuters article

Glaxo buys Pliva's R&D drug unit in $50 mln deal

I think we're going to see a lot of this kind of deal...the big companies will be spending money to buy other companies in order to get something in the pipeline...


LONDON/ZAGREB Feb 14 (Reuters) - Europe's biggest drugmaker, GlaxoSmithKline Plc, said on Tuesday it had bought the research institute of Croatian drug maker Pliva in a deal worth up to $50 million.

Pliva will receive an upfront sum of $35 million with possible further payments of up to $15 million depending on the entry of certain early stage projects into clinical development.

Pliva will also receive royalties on certain experimental drugs if they reach the market.

link to full Reuters artcile

N.J. Buoys Efforts of Biotech Entrepreneurs

Feb. 12--The scores of biotechnology companies that dot the New Jersey landscape do everything from extract enzymes from pig hearts and electric eels to "re-engineer" human cells.

But they all seem to have one thing in common -- a motivating entrepreneurial spirit that allows the staff to overlook the risks inherent to the burgeoning industry and work toward a common goal.

"You have to have a lot of faith to do this," said Dr. Andrew Pecora, the chairman and executive director of Hackensack University Medical Center's Cancer Center, who for nearly a decade has run a small biotech company in the growing field of cell therapy.

In many instances, biotech companies gamble on a single product, a treatment that with regulatory approval might one day generate millions of dollars in profits or be sold for millions to a large pharmaceutical company.

But, according to Debbie Hart, president of the Biotechnology Council of New Jersey, it often takes a decade or more and $1 billion in investments before that product reaches its intended patients, if it reaches them at all.

New Jersey's efforts to create an environment where entrepreneurs will believe the risks are worth it include tax credits, grants and loans to biotech start-ups, research funding, and even office rent subsidies.

And two years ago New Jersey established a $10 million venture capital fund to provide seed money for new companies.

For its efforts, the state was recently named one of the top five biotech regions in the world by FierceBiotech, an influential industry trade publication.

Hart said a new survey to be released in the spring is likely to reveal that the number of biotechs has risen to more than 150 from 80 in 1998.

link to full article

Pitt Critical of Stem Cell Researcher

My oldest is considering Pitt for college...

PITTSBURGH - A U.S. stem-cell expert committed "research misbehavior" in his work with a now-disgraced South Korean scientist, but his actions don't constitute scientific wrongdoing, university investigators said Friday.

The University of Pittsburgh Research Integrity panel concluded that Dr. Gerald Schatten "likely did not intentionally falsify or fabricate experimental data" and said there was no evidence he knew of misconduct in Dr. Hwang Woo-suk's work in South Korea.

However, it found that Schatten, as co-author with Hwang on a 2005 article, "did not exercise a sufficiently critical perspective as a scientist."

The article purported to show the creation of stem cells from the world's first cloned human embryos.

link to full AP article

VITAL EVIDENCE

In U.S. Cancer Deaths, A Minus May Be a Plus

No one is declaring victory, but the number of Americans dying from cancer has dropped for the first time, according to a report being released today.

The most recent federal data show that deaths from cancer fell from 557,271 in 2002 to 556,902 in 2003. While it was a decline of only 369, it marked the first documented drop since the government started collecting statistics in 1930.

"This represents a real milestone," said Michael Thun of the American Cancer Society, which analyzed the data.

The death rate from cancer has been dropping since the early 1990s, but the total number of Americans dying continued to increase because the population is growing and getting older.

Link to full artcile from the Washington Post

Apocalypse now: fears of gene doping are realised

Unleashing the power of the human genome...will make unleashing the unleashing of the power of the atom look like child's play...

who said that?

A new substance has emerged that suggests the next stage in the drugs battle has started

THE grim new world of gene doping, for so long viewed as the apocalyptic future of illegal performance-enhancement in sport, has dawned in Germany. Experts had been concerned that advances in gene therapy would start to impact on sport by the time of the Beijing Olympics in 2008. However, evidence from a court case in Magdeburg, Germany, suggests that a new brand of cheats could be injecting in time for the Turin Winter Games, which start next week.

Gene doping is the big fear among those fighting for clean sport. It involves manipulation of the human genetic code and thus evades standard detection methods. And a German court has identified the distribution among coaches of a substance called Repoxygen, which works in this way to produce erythropoietin (EPO) indigenously.

“You would have to be blind not to see that the next generation of doping will be genetic,” Dick Pound, the chairman of the World Anti-Doping Agency, told scientists only two months ago. It seems that this next generation has arrived.


link to full article

The ISPE Survey

I got the ISPE survey regarding the professional certification program...

here's the link to the main page...

hard to figure if they're getting the right emphasis...

very little if anything on public safety...heavy on validation, commissioning , and development activities...

Pataki announces biotechnology grant program

The job creration machine keeps on rolling...

ALBANY, N.Y. -- Gov. George Pataki and the Republican-led state Senate are backing a program that aims to generate $800 million in new investment in biotechnology and medical research at institutions across the state.

The program, announced by Pataki and Senate Majority Leader Joseph Bruno, would create a $200 million grant initiative they hope will generate another $600 million in federal, not-for-profit and private sector matching funds.

The initiative, first announced earlier this month in the governor's State of the State address, will fund research at universities and hospitals around New York.

The plan would establish a two-part $200 million program including $40 million in capital funding, already authorized, and $160 million financed by the state Charitable Asset Foundation, a charitable trust formed with the proceeds of the Empire Blue Cross Blue Shield conversion to a for-profit company. The money would be used to recruit researchers and scientists and to buy new technology and equipment.

link to full article from newsday.com

Gates Pledges $900 Million for TB Research

DAVOS, Switzerland (AP) -- Bill Gates said Friday his charitable foundation will boost its funding for tuberculosis eradication from its current level of $300 million to $900 million during the next decade.

The effort is part of a larger campaign against tuberculosis announced at the World Economic Forum. The disease killed 1.6 million people last year.

The announcement came as Nigerian President Olusegun Obasanjo, British treasury chief Gordon Brown and Gates called for help to treat 50 million people and prevent 14 million tuberculosis deaths worldwide over the next decade.

"This is a very tough disease," the Microsoft Corp. chairman and co-founder said. "It is going to take all of us - private sector, the pharmaceutical companies, philanthropy and governments in countries that have the disease - to participate as well."

link to full AP article

FDA Panel Recommends OTC Weight-Loss Pill

and I've been trying to lose weight by eating less...How old-fashioned...


WASHINGTON - Federal health advisers voted Monday to recommend over-the-counter sales of a weight-loss pill now sold only with a prescription.

GlaxoSmithKline Consumer Healthcare still needs final Food and Drug Administration approval before it can sell a nonprescription version of orlistat, a diet pill already marketed in prescription form as Xenical. The FDA approved the prescription version of the fat-blocking pill made by Roche in 1999.

A joint FDA advisory committee voted 11-3 to recommend approval late Monday following a daylong hearing. The agency usually follows the recommendations of its outside panels of experts, but its final decision could take months. If approved, orlistat would be the first weight-loss drug sanctioned for over-the-counter sales. Roche will continue selling Xenical regardless.

"We are excited about the potential opportunity to provide consumers with an FDA-approved over-the-counter option that promotes gradual yet meaningful weight loss," said George Quesnelle, president of GlaxoSmithKline Consumer Healthcare North America.

link to full AP article

Biotech Center To Match VC Funding With Loans

Great idea, except the money can't be used for physical facilities...

Bootstrap biotechnology companies will have an easier time gaining traction thanks to a program launched by the North Carolina Biotechnology Center that will match venture capital investments with loans of up to $250,000. The Strategic Growth Award is designed to offer startup companies an additional avenue to help alleviate funding shortfalls that often occur between seed-funding stages and later venture capital investments, according to a written statement from the biotechnology center. SGA loans won't be restricted solely to research funding, say biotech center officials. The new loans can also be used for hiring employees, securing patent rights and pursuing business development and licensing opportunities. The loans, however, must be matched with an equal investment from a venture capital firm. While SGA loans cannot be used for physical facilities or to compensate corporate executives, these restrictions will not apply to the matching venture funds, officials say. The loan program is open only to North Carolina biotech companies involved in life sciences, natural products, agriculture, veterinary medicine or environmental endeavors. Triangle Business Journal reported in its Oct. 14, 2005 print edition that the Biotech Center was considering the loan program. The North Carolina Biotechnology Center is a private, nonprofit corporation headquartered near Research Triangle Park and supported by the North Carolina General Assembly. The organization operates four additional offices in Greenville, Wilmington, Winston-Salem and Asheville, with plans for a fifth office in Charlotte.

link to story on biospace.com

The FDA celebrates 100 Years!!!

link to site

This week in FDA history- January 10, 1961:

External D&C No. 15, a red color additive widely used in cosmetics before it was taken off the FDA's list of approved colors in 1960 because of safety concerns, is cleared for uses outside of the body. But this leaves fans of rosy lips little to smile about, since this "external use" doesn't include lipsticks.

MedImmune inflates flu vaccine production capacity to boost market presence

11/01/2006 - MedImmune will soon ramp up production of its intranasal flu vaccine after the US Food and Drug Administration (FDA) approved its new and larger flu vaccine manufacturing facility in Speke, England.

The new facility is 10 times larger than MedImmune's existing manufacturing facility in Speke, and will allow the company to produce up to 15 million doses per month, or about 90 million doses per influenza manufacturing season, of its trivalent, intranasal flu vaccine, FluMist.
This is a mammoth increase in vaccine production considering the company only produced 3 million doses of FluMist this year and the decision to ramp up production may seem somewhat ambitious.

link to full article

Penicillin and Amoxicillin's days are numbered

03/01/2006 - The threat of antibiotic resistance reared its ugly head again after US researchers found that the most common antibiotic treatments do not work in a significant number of cases, leading for calls to find viable alternatives to ageing, established, antibiotics.

Antibiotic resistance has become a problem in the pharmaceutical industry that no one wants to or knows how to deal with. This could be because the acceptance of a need for alternatives would essentially mean pharma has lost confidence of antibiotics such as penicillin and amoxicillin.
Researchers from the University of Rochester started with the analysis of data from 11,426 children who has suffered a common throat infection.

They found that 25 per cent of children given penicillin, along with 18 per cent given amoxicillin treatment needed further treatment within weeks.

link to full article

Coffee may lower breast cancer risk for some women

NEW YORK (Reuters Health) - Women with BRCA1 gene mutations, which confer a high risk of developing breast cancer, might decrease their risk by drinking a lot of coffee, according to a multicenter team of investigators.

Dr. Steven A. Narod, of the University of Toronto, Ontario, and colleagues examined the association between coffee consumption and the risk of breast cancer among 1690 high-risk women with BRCA1 or BRCA2 mutations.

The study included women from 40 clinical centers in four countries. A self-administered questionnaire was used to assess the average lifetime coffee consumption.

The likelihood of developing breast cancer among BRCA mutation carriers who drank 1 to 3 cups of coffee daily, 4 to 5 cups, or 6 or more cups was reduced by 10 percent, 25 percent and 69 percent, respectively, compared to those who drank no coffee, according to the report in the International Journal of Cancer.

When the investigators classified the women by mutation status, they found significant protection from coffee

link to reuters.com for full article

New blow to S Korea clone work

South Korea's disgraced human cloning scientist did not produce any stem cells tailored to individual patients as claimed, a panel has concluded.
A Seoul National University panel said it believed that Hwang Woo-suk never had the data he said he had.

Dr Hwang quit last week after the panel said some research was fabricated.

Correspondents say the finding is important as individually tailored stem cells were seen as a key to treating diseases like diabetes and Alzheimers.

The scientist maintains he has developed technology to produce such stem cells.

The panel said it would continue its investigation into other research by Dr Hwang, including the authenticity of a cloned Afghan hound which was claimed to be the world's first cloned dog.

link to full article by BBC