Too much of a good thing: When testosterone is bad for muscles

has anybody asked certain profesional athletes about this?

EAST LANSING, Mich. — A mouse created by Michigan State University scientists studying a disease thought to be a neurological disorder that weakens men has exposed two surprises: Testosterone appears to be the culprit and it’s attacking muscles, not nerves.

The muscles of male mice genetically engineered in the laboratory of Cynthia Jordan, professor of neuroscience and psychology, have extra receptors that latch onto testosterone – a trick that left researchers anticipating mouse versions of bulked up body builders. Instead, these mice developed into shrunken weaklings. More significantly, their condition precisely imitated a rare human condition called Kennedy’s Disease.

The results, reported in the Oct. 29 online issue of the Proceedings of the National Academy of Sciences, not only directly contradict conventional wisdom about the root of Kennedy’s Disease, but also offer significant hope. Researchers say these new results make a strong case that Kennedy’s Disease is a muscular disease rather than a neurological disease, and put testosterone in the category of cause, not cure.

“When we started studying this little wimp mouse, we were surprised to find that we inadvertently created a model for Kennedy’s Disease,” Jordan said. “Our story provides some hope, because it’s an easier problem to target muscles therapeutically than the motor neurons in the spinal cord. Our sick mice get well when we take testosterone away from them.”

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Girls to get cervical cancer jabs

The Brits come on-line...I think more time is needed to look for side-effects...

LONDON (Reuters) - All girls aged 12 to 13 in England will be vaccinated against the sexually transmitted virus that causes most cases of cervical cancer, the government said on Friday.

From next autumn, girls will receive three injections at school over six months in a move that could save up to 400 lives each year, the Department of Health said.

Teenagers up to the age 18 will also be vaccinated during a one-off programme lasting two years. The scheme is also expected to be adopted in Scotland, Wales and Northern Ireland.

"As a society, we need to do more to prevent disease and not just treat it," Health Secretary Alan Johnson said in a statement.

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Stanford researchers get precise picture of cell target for drugs

It's too bad they didn't include the picture in the press release...

STANFORD, Calif. — More than half of all drugs given to patients work by targeting a particular type of “docking station,” or receptor, found on body cells, to steer the cell’s machinery toward healing an illness. Researchers from Stanford University School of Medicine and the Scripps Research Institute have determined what one of those receptors looks like at the molecular level, giving them the keys to greater control of the process.

A scientific feat, identifying the structure of these docking stations—called G protein-coupled receptors—can direct the future design of drugs that will precisely bind to specific receptors. Precise binding by a drug can stimulate or block that particular receptor’s normal activity, leading to more powerful treatment while minimizing bothersome side effects.

“The majority of hormones and neurotransmitters work through one of these receptors,” said Brian Kobilka, MD, the senior author of three new publications devoted to the structure of a particular G protein-coupled receptor called beta 2-adrenergic receptor. “All these receptors are structurally related, which means that knowing more about a specific one will advance the whole field.”

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Controversial DNA scientist retires

It's a shame that this will be how this person will be remembered...

in the meantime...don't let the door hit you on your way out...

NEW YORK - James Watson, famous for DNA research but widely condemned for recent comments about intelligence levels among blacks, retired Thursday from his post at a prestigious research institution.

Watson, 79, and the Cold Spring Harbor Laboratory in New York announced his departure a week after the lab suspended him. He was chancellor of the institution, and his retirement took effect immediately.

Watson shared a Nobel Prize with Francis Crick and Maurice Wilkins in 1962 for co-discovering the structure of the DNA molecule. He is one of America's most prominent scientists.

In his statement Thursday, Watson said that because of his age, his retirement was "more than overdue. The circumstances in which this transfer is occurring, however, are not those which I could ever have anticipated or desired."

Watson, who has a long history of making provocative statements, ran into trouble last week for remarks he made in the Sunday Times Magazine of London. A profile quoted him as saying that he's "inherently gloomy about the prospect of Africa" because "all our social policies are based on the fact that their intelligence is the same as ours — whereas all the testing says not really."

He said that while he hopes everyone is equal, "people who have to deal with black employees find this is not true." He also said people should not be discriminated against because of their color, adding that "there are many people of color who are very talented."

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California Fires impact Pharm Bio Industry...

Pfizer not alone in feeling the heat of California fires

As the fires in California continue to rage, Pfizer and other pharma and biotech companies all over Southern California are bracing themselves for closures and even evacuations of their facilities.

This never dawned on me...but it represents a very real threat...

As if Pfizer isn't feeling the heat enough this week thanks to its disappointing financial results and its decision to drop Exubera (inhalable insulin), the world's biggest pharma company has today closed its La Jolla research and development (R&D) site in San Diego.

The decision will be re-evaluated daily but the head of the La Jolla campus, Kitty Mackey, said that it was important the 1,000 employees there "take the time to care for their families and loved ones," as many of them live in areas impacted by the fire emergency.

Pfizer is hardly alone in their problems though - within a 10-mile radius of the La Jolla campus are many major educational and research facilities such as the University of California at San Diego (UCSD), The Scripps Research Institute, the Salk Institute for Biological Studies and some 200 biotech firms.

Acros the whole of San Diego County, there are more than 500 life science companies employing more than 36,000 people, according to industry association Biocom. The companies range from small biotechs to some of the 'biggest names' in drug development, such as Johnson & Johnson (J&J), Bristol-Myers Squibb (BMS), Amgen, Biogen Idec, Genentech and, of course, Pfizer. Between them, they generate over $23m (€16.2m) for the economy every day and so the financial impact of closures should not be underestimated.

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New nerves grown from fat cells

I should be ok then...plenty of supply...

New nerves grown from stem cells taken from a patient's fat could be available by 2011, researchers have said.

They could potentially be used to repair peripheral nerves left severed by surgery or accidents.

Manchester University scientists plan to place the new nerve tissue inside a biodegradable plastic tube, which can be used to rejoin the two broken ends.

The findings of their study on rats, in Experimental Neurology, could help hundreds of people a year, they say.

The patients will not be able to tell that they had ever 'lost' [the feeling to] their limb

At the moment, only limited techniques are available to help repair nerves outside the spinal cord, even though they have a limited capacity to regrow.

Other nerves from elsewhere in the patient are often used, which does not restore perfect function and can cause further damage.

The Manchester technique uses stem cells - immature cells which the body naturally uses to create different tissue types.

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Improving Product Safety...

With aspirin leading the way, more and more products are coming out in fiercely protective packaging designed to prevent consumers from consuming them. These days you have to open almost every consumer item by gnawing on the packaging.

Go to any typical consumer household and you'll note most of the products- food, medicine, compact discs, appliances, furnitue- are covered with bite marks, as though the house is infested with crazed beavers. The floor will be gritty with little chips of consumer teeth.

Many consumers are also getting good results by stabbing their products with knives. (Note: this practice is not recommended...)

Fifty-eight percent of all serious household accidents result from consumers assaulting packaging designed to improve consumer safety...




Thanks to Dave Barry for helping us celebrate our 500th post...

Indian firm takes over German biologics plant

India just keeps coming...

An Indian firm has taken over the contract biologics manufacturing business of German corporation Siegfried.

The deal is a further sign of the ambition of Indian firms to break into the burgeoning biopharmaceuticals market, which was identified as a key target growth area for India at the recent Interphex show in Mumbai, and is tipped to generate $5bn (€3.5bn) in revenue in the country by 2010, up from its current figure of $1.5bn.

India's Avesta Biotherapeutics and Research is now the new owner of Berlin-based Siegfried Biologics and its 50 employees, gaining a capability in developing biologics, from cell line generation, upstream process development, through to manufacturing.

Avesta plans to use the facility to make an entry into the world of making good manufacturing practice (GMP)-compliant biopharmaceuticals for the regulated US and European markets.

However, the Bangalore-based firm said it will initially concentrate on manufacturing biologics for the semi-regulated markets of Brazil, Russia, India and China, where small molecule drugs prevail in the market.

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Biotech industry facing closer scrutiny

Florida weighs in...

and new Jersey gets a mantion...'cause we're talking about regulations...

Biotechnology as an industry is growing, but with its higher profile has come greater scrutiny from government, which also is one of its biggest customers.

Industry lobbyists meeting here Wednesday on the second and final day of the 10th annual BioFlorida conference outlined the increased regulatory activity biotech companies are running into from federal and state governments.

Forty-six states, including Florida, enacted "anti-industry" legislation last year, said Christopher Badgley, vice president of the Pharmaceutical Research and Manufacturers of America.

The industry faces drug-price controls, limits on patient access to new treatments, drug-safety concerns, mounting clinical-trial disclosure rules and changes to intellectual-property laws, he said.

"Public policy is often emotion-based. It has less to do with what's the best policy and more with what gets (officials) elected," he said.

According to the lobbyists, New Jersey's attorney general has formed a task force to investigate compensation drug and biotech companies pay to some doctors who test new treatments. In Washington state, the legislature established a board to review a new medical technology or treatment and to recommend whether it should be supported by state employee health coverage.

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Chemists turn killer gas into medical cure

fascinating stuff...

the stunning stuff is in the fifth paragragh when they start taking about "refining the design of the molecules


SHEFFIELD, England, Oct. 16 (UPI) -- British scientists have developed a technology that uses small amounts of carbon monoxide to help people undergoing heart surgery or organ transplants.

Despite its deadly reputation, carbon monoxide can boost the health of such patients, as well as people suffering from high blood pressure, by reducing inflammation and increasing blood flow.

The problem has been in how to safely deliver the correct amount of CO into the body.

University of Sheffield researchers have developed water-soluble molecules that, when swallowed or injected, safely release small amounts of CO inside the body.

"The molecules dissolve in water, so they can be made available in an easy-to-ingest, liquid form that quickly passes into the bloodstream," said Professor Brian Mann, who led the research. "As well as making it simple to control how much CO is introduced into a patient's body, it will be possible to refine the design of the molecules so that they target a particular place while leaving the rest of the body unaffected."

The new CO-releasing molecules were developed in partnership with Dr. Roberto Motterlini at the Northwick Park Institute for Medical Research and with funding from Britain's Engineering and Physical Sciences Research Council.

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Global biotech firms on India quest

more on India...

Indian shores turn attractive for clinical trials.

Close on the heels of global pharmaceutical giants, international biotechnology companies are also finding India an irresistible attraction, though for different reasons.

If the low-cost availability of raw materials was the major reason for global generic pharmaceutical majors such as Teva, Mylan and Actavis to have an Indian base, the emerging opportunities in clinical trials is driving the biotech majors towards the country.

Of the top-10 global biotech companies, the biggest two — Amgen and Biogen — have already set up wholly owned subsidiaries in the country.

Others, such as Genentech, Serono, Chiron, Gilead, among others already have their presence in India through marketing partners and are in the process of exploring business opportunities in a big way.

For instance, Biogen Idec, the oldest biotech company in the US, announced the setting up of its wholly owned domestic subsidiary Biogen Idec Biotech India last month. Biogen, which had a sales of $2.7 million in 2006, also indicated its commitment of significant investments in the Indian R&D segment.

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MAbs are hottest segment of biotech industry

a good explanation of the pharm biotech market relative to how patent expiration will impact growth from FierceBiotech and Datamonitor

Looking for the hottest segment of the biotech industry? Then take a look at monoclonal antibodies (mAbs). A new Datamonitor report projects 14 percent annual growth in the market for the antibody drugs, which mimic the body's own immune system. That's by far the fastest-growing segment of the industry. MAbs currently generate global revenues of around $20 billion and include such blockbusters as Avastin, Herceptin, Remicade, Rituxan, Humira and Erbitux.

A major revolution in the mAb market came when drug developers moved away from murine (mouse) antibodies to partially or fully humanized antibodies, which are safer and more effective and allowed mAbs to gain wider usage among patients. And many current mAb therapies are effective for a large number of diseases, making them even more attractive to drug developers.

link to article

Study Reveals How Stem Cells Decide To Become Either Skeletal or Smooth Muscle

I haven't been to Rochester in years...

Researchers have discovered a key protein that controls how stem cells “choose” to become either skeletal muscle cells that move limbs, or smooth muscle cells that support blood vessels, according to a study published today in the Proceedings of the National Academy of Sciences (PNAS). The results not only provide insight into the development of muscle types in the human fetus, but also suggest new ways to treat atherosclerosis and cancer, diseases that involve the creation of new blood vessels from stem cell reserves that would otherwise replace worn out skeletal muscle. The newly discovered mechanism also suggests that some current cancer treatments may weaken muscle, and that physician researchers should start watching to see if a previously undetected side effect exists.

Thanks to stem cells, humans develop from a single cell into a complex being with as many as 400 cell types in millions of combinations. The original, single human stem cell, the fertilized embryo, has the potential to develop into every kind of human cell. As we develop in the womb, successive generations of stem cells specialize (differentiate), with each group able to become fewer and fewer cell types. One set of mostly differentiated stem cells has the ability to become bone, blood, skeletal muscle or smooth muscle. Many human tissues keep a reserve of stem cells on hand in adulthood, ready to differentiate into replacement parts depending on the stimuli they receive. If body signals that skeletal muscle needs replacing, the stem cells take that route. If tissues signal for more blood vessels, the same stem cells may become smooth muscle that supports the lining of blood vessels.

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Mathematicians help unlock secrets of the immune system

A group of scientists, led by mathematicians, has taken on the challenge of building a common model of immune responses. Their work will radically improve our understanding of the human immune system by allowing all the scientific disciplines working on it to have a common reference point and language. The mathematicians, funded by the Biotechnology and Biological Sciences Research Council (BBSRC), will investigate how the different cellular components of the immune system work together and devise a theoretical and computational model that can be used by immunologists, mathematicians, computer scientists, physicists and engineers.

The model promises to help a multi-disciplinary research community work together to bring about medical advances for patients. The project, the Immunology Imaging and Modelling (I2M) Network, is highlighted in the quarterly research highlights magazine of the Biotechnology and Biological Sciences Research Council (BBSRC) this week.

The immune system is one of the most fascinating and complex systems in the human body and scientists still do not fully understand how it works. Immunology has traditionally been a qualitative science, describing the cellular and molecular components of the immune system and their functions. However, to advance our understanding of how the body fights disease there is a pressing need to better understand how the components work together as a whole and provide this information in a quantitative format which can be accessed by the entire scientific community.

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FDA Announces Initiative to Bolster Generic Drug Program

The U.S. Food and Drug Administration today outlined a program aimed at increasing the number and variety of generic drug products available to consumers and health care providers. Generic drugs generally cost less than their brand-name counterparts and competition among generics has been a key factor in lowering drug prices. The Generic Initiative for Value and Efficiency, or GIVE, will help the FDA modernize and streamline its generic drug approval process.

The agency approved or tentatively approved a record of 682 generic drugs products in fiscal year 2007, over 30 percent more than the previous year.

“To keep pace with the increasing number of generic drug applications, FDA will implement some changes to the generic drug approval process,” said Gary Buehler, director of FDA’s Office of Generic Drugs. “The GIVE plan outlines ways to maximize the use of our resources so that FDA can review and approve even more high quality generic drugs during the upcoming fiscal year than it did in 2007.”

As part of the GIVE efforts, FDA is revising the review order for certain drug applications. For example, first generic products, for which there are no blocking patents or exclusivity protections on the reference listed drug, are identified at the time of submission for expedited review. This will mean that these products, for which there are currently no generic products on the market, may reach the consumer much faster.

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Fathers of 'targeted genetics' scoop Nobel prize

08/10/2007 - The discoverer of embryonic stem cells (ES cells) and two other scientists have won a Nobel Prize for their work to develop a 'magic wand' to modify the mouse genome.

The pioneering research by the trio has allowed scientists both to discover the function of a gene and create of animal models of human disease.

Professor Sir Martin Evans of Cardiff University shares the 2007 Nobel Prize in Physiology or Medicine with a second UK scientist, Oliver Smithies, and the Italian Mario Capecchi "for their discoveries of principles for introducing specific gene modifications in mice by the use of embryonic stem cells".

The trio have been tipped to win the Nobel for several years after winning the 2001 Lasker Award for 'Basic Medical Research'. These awards are also known as 'America's Nobels' and are one of the most coveted accolades in medical science. There are literally dozens of examples of eminent researchers winning both during their careers.

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Texas Investor Eyes Space Station as Orbiting Pharma Lab

Cool!!!...

even if it makes no sense...

MOFFETT FIELD, California -- A swaggering Texas investor with a famous name wants Big Pharma to pick up the tab for the International Space Station when NASA eases off.

Thomas Pickens III thinks the pharmaceutical industry and the space station need each other.

Drug discovery is an arduous and extremely expensive project. But in space, molecules do miraculous things. Disease-causing proteins crystallize so well -- growing larger and clearer -- that finding a drug to stop the protein's damaging activities could happen months, if not years, faster.

Scientists have known for decades that some science works better in space -- but it hasn't been easy to get experiments up there. Now, with NASA planning to reduce its $2.6 billion annual investment beginning in 2015, the agency is throwing the space station open for private enterprise. And the Texas financial scion and multimillionaire is ready to transform space science with an injection of capitalism.

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Officials say drug caused Nigeria polio

not good news...

LONDON - A polio outbreak in Nigeria was caused by the vaccine designed to stop it, international health officials say, leaving at least 69 children paralyzed.

It is a frightening paradox in a part of the world that already distrusts western vaccines, making it even tougher to stamp out age-old diseases.

The outbreak was caused by the live polio virus that is used in vaccines given orally — the preferred method in developing countries because it is cheaper and doesn't require medical training to dispense.

"This vaccine is the most effective tool we have against the virus, but it's like fighting fire with fire," said Olen Kew, a virologist at the U.S. Centers for Disease Control and Prevention.

The CDC and the World Health Organization announced the cause of the polio outbreak last week, even though they knew about it last year.

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Amgen shelves plans for plant in Ireland

DUBLIN, Oct 3 (Reuters) - U.S. biotechnology company Amgen Inc (AMGN.O: Quote, Profile, Research) said on Wednesday it had shelved plans for a production plant in southern Ireland which would have generated 1,100 jobs. Amgen said the decision to postpone indefinitely the building of the factory in County Cork was "based purely on developments relating to Amgen's global business" and was no reflection on Ireland.

In a statement, the company said it would keep the site on which the new plant -- intended mainly to supply the European market -- was to be built. Amgen, whose business has been affected by tighter regulatory restrictions on drugs, has embarked on a cost-cutting programme that includes reducing its global workforce by up to 14 percent.

Plans for the Cork facility were announced last year. It had been expected to be operational by 2012.

Drugs made by Amgen, which is headquartered in California, include Vectibix for cancer and arthritis treatment Enbrel.

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Vulnerable germ labs tough to identify

WASHINGTON - Federal terror-fighting agencies can't identify all the American research laboratories that could become targets of attackers, congressional investigators have found.

The Government Accountability Office asked a dozen agencies whether they kept track of all the labs handling dangerous germs and toxins, or knew the number. All responded negatively.

Combine this with the previous story

WASHINGTON - American laboratories handling the world's deadliest germs and toxins have experienced more than 100 accidents and missing shipments since 2003, and the number is increasing steadily as more labs across the country are approved to do the work.

The findings were prepared for a House Energy and Commerce Committee hearing Thursday.

The government regulates 409 laboratories approved to work with 72 of the world's deadliest organisms and poisons, including anthrax, bird flu virus, monkeypox and plague-causing bacteria.

But less is known about other labs that work with organisms that cause whooping cough, tuberculosis, gonorrhea, meningitis, typhoid fever, hepatitis, herpes, several strains of flu, rabies, HIV and SARS.

The GAO said U.S. intelligence agencies, including the FBI, told its investigators they need to track all labs that could be vulnerable to terrorism.

U.S. intelligence agencies said they already are handicapped by the failure of some foreign countries to regulate the shipment or possession of biological agents.

The Associated Press reported this week that American laboratories handling the world's deadliest germs and toxins have experienced more than 100 accidents and missing shipments since 2003, and the number is increasing as more labs do the work.


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When Thinking about 21st Century Biotech, Don’t Overlook Georgia

another region weighing into the biotech industry as the source of new jobs...

RESEARCH TRIANGLE PARK - Quick quiz: Which state does this phrase most apply:

“21st Century Bioeconomy”

North Carolina comes to mind. California, certainly. Massachusetts, of course.

What about Georgia?

Yes, the Peach State is conceding no ground in development of a biotech industry with applications in pharmaceutical development, biofuels and much more. For example, last month, state and local officials announced plans to turn part of U.S. Army base Fort McPherson into a biotech campus.

The goal: Produce a technology hub similar to Research Triangle Park or MIT.

While North Carolina justifiably takes pride in its booming biotech industry (more than 400 companies, more than 40,000 jobs), leaders in the biotech sector constantly warn that the state can’t take the sector for granted. Other states – especially Georgia – have targeted life sciences and biotech as major economic growth objectives.

Georgia’s drive was highlighted this week at the annual Georgia Bio conference and the release of the Georgia Bio organization’s second annual report on the state’s life science sector. It’s title speaks to Georgia’s public and private sector commitment to biotech: “Shaping Infinity.”

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Novartis And MIT Study Drug Production

Maybe we can all get some new work in bulk API production...

Ten-year agreement targets continuous pharmaceutical manufacturing

Novartis and MIT have launched a partnership aimed at transforming pharmaceutical manufacturing. Novartis hopes the pact will allow it to convert its drug production infrastructure from multisite batch operations to continuous ones that consolidate chemical synthesis, formulation, and packaging in one location.

The drug company is investing $65 million in research at MIT over the 10-year period of the partnership. The project will involve seven to 10 MIT faculty members, as well as students, postdoctoral fellows, MIT staff scientists, and Novartis engineers and scientists. Research will be conducted primarily through MIT Ph.D. programs and then transferred to Novartis for further development to industrial-scale projects.

Novartis aims to convert batch manufacturing operations, such as this one in Switzerland, to continuous ones."This partnership demonstrates our commitment to lead not only in discovering innovative treatments for patients, but also in improving manufacturing processes, which are critical to ensuring a high-quality, efficient, and reliable supply of medicines to patients," says Novartis CEO Daniel Vasella.

Thomas Van Larr, head of global technology operations for Novartis, says the drug industry's heritage in batch manufacturing stems in part from the relatively small volumes of high-value active ingredients needed to make drugs. However, many products, such as Novartis' blood pressure medication Diovan, are produced at a volume that could support continuous chemical production, according to Van Larr.

"To truly go continuous is going to involve a massive effort employing new technology," he says. The 10-year project, he adds, is designed to develop technologies that will be implemented over a longer time frame, up to 20 years.

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U.S. labs mishandling deadly germs

I have had some limited discussions with people knowledgeable in this subject...

the drive to construct these sophisticated research facilties has led to a dramtic shortfall in the availablity of personnel that have the proper training and experience required to function in these demanding environments...

WASHINGTON - American laboratories handling the world's deadliest germs and toxins have experienced more than 100 accidents and missing shipments since 2003, and the number is increasing steadily as more labs across the country are approved to do the work.

No one died, and regulators said the public was never at risk during these incidents. But the documented cases reflect poorly on procedures and oversight at high-security labs, some of which work with organisms and poisons so dangerous that illnesses they cause have no cure. In some cases, labs have failed to report accidents as required by law.

The mishaps include workers bitten or scratched by infected animals, skin cuts, needle sticks and more, according to a review by The Associated Press of confidential reports submitted to federal regulators. They describe accidents involving anthrax, bird flu virus, monkeypox and plague-causing bacteria at 44 labs in 24 states. More than two-dozen incidents were still under investigation.

The number of accidents has risen steadily. Through August, the most recent period covered in the reports obtained by the AP, labs reported 36 accidents and lost shipments during 2007 — nearly double the number reported during all of 2004.

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