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.

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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."

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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.

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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.

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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.

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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.

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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."

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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.

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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.”

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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.

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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.

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