Dr. Fein- And Swedesboro makes three...

An interesting series of posts regarding diversion of classified drug products...

The GMP concept of "State of Control" appears to extend further through the supply chain than just manufacturing...


link to full article

drug channels blog

China Shuts Down Leukemia Drug Maker

perhaps the Chinese understand that they need to make serious progress on this issue...

SHANGHAI, China (AP) -- China's food and drug safety agency has revoked the license of a company responsible for making tainted leukemia drugs blamed for causing leg pains and partial paralysis among dozens of patients.

State-owned Shanghai Hualian Pharmaceutical Co., a unit of China's biggest drug maker Shanghai Pharmaceutical (Group) Co., will also be fined the highest amount allowed under law and profits from the sale of the contaminated drugs will be confiscated, the State Food and Drug Administration said in a statement on its Web site seen Thursday.

Some Shanghai Hualian executives were detained by police on suspicion they deliberately withheld information about violations of production standards during the investigation, the SFDA's statement said.

A report in the state-run newspaper Shanghai Daily said the maximum fine for a breach of regulations was only $4,000.

Shanghai city government officials said they were cooperating with the SFDA in resolving the case.

Calls to Shanghai Pharmaceutical rang unanswered Thursday morning. Calls to numbers listed for Shanghai Hualian Pharmaceutical were answered with a "this number does not exist" recording.

The investigation into Shanghai Hualian Pharmaceutical was one of a slew of cases involving contaminated or bogus drugs and foods that have prompted tighter enforcement of safety regulations

link to full article

Brain 'irrelevance filter' found

this may explain a lot, especially for some people we all wonder about...

Scientists believe they have located a new brain area essential for good memory - the "irrelevance filter".

People who are good at remembering things, even with distractions, have more activity in the basal ganglia on brain scans, the Swedish team found.

The work in Nature Neuroscience could help explain why some people are better at remembering things than others.

Clinically, it could also aid the understanding of attention deficit hyperactivity disorder (ADHD).

The ability to hold information in the mind so that it is immediately accessible is known as working memory.

We use working memory all of the time - for example, when doing a simple maths calculation in our head or recalling a telephone number.

Working memory is important because it gives a mental workspace in which we can hold information whilst mentally engaged in other relevant tasks, which is crucial for learning.

Its capacity is limited and seems to vary from person to person.


These variations are not just due to having a larger or smaller memory store, but also due to differences in how effectively irrelevant items are kept out of memory, the Karolinksa Institute researchers believe.

link to full article

Pfizer plans more off-shoring and outsourcing

More on the off-shoring trend...previous post here

Pfizer is looking to Asia for both R&D and manufacturing outsourcing and to help it cut costs in a bid to mitigate the effects of patent expiries and competition from generic drugs.

Pfizer announced plans to increase its R&D presence in Asia at its Hong Kong investor meeting on Friday, while saying it is also look to double the amount of manufacturing outsourcing to 30 per cent.

The pharma giant has struggled in the past year and the high profile clinical trial failure of its cholesterol-lowering drug Torcetrapib has only matters worse.

Torcetrapib would have enabled Pfizer to defend the patents its cholesterol drug Lipitor (atorvastatin) that are due to expire in 2011, potentially creating a $13bn hole in the company's revenues.

In addition, Pfizer's pipeline has been criticised from many quarters, with even the company's new president of global R&D stating "I'm the first to admit [the drug pipeline] is not as rich as I'd like it to be."

To help combat this Pfizer will look to bolster its Asian R&D, targeting China, India, Japan and South Korea.

New sites in these areas would help the company bolster its share of the Asian pharmaceutical market which is predicted to grow to $200bn by 2017.

link to full article

Newly-identified exercise gene could help with depression

In case you were trying to decide whether or not to go out for that jog...

New Haven, Conn.—Boosting an exercise-related gene in the brain works as a powerful anti-depressant in mice—a finding that could lead to a new anti-depressant drug target, according to a Yale School of Medicine report in Nature Medicine.

“The VGF exercise-related gene and target for drug development could be even better than chemical antidepressants because it is already present in the brain,” said Ronald Duman, professor of psychiatry and senior author of the study.

Depression affects 16 percent of the population in the United States, at a related cost of $83 billion each year. Currently available anti-depressants help 65 percent of patients and require weeks to months before the patients experience relief.

Duman said it is known that exercise improves brain function and mental health, and provides protective benefits in the event of a brain injury or disease, but how this all happens in the brain is not well understood. He said the fact that existing medications take so long to work indicates that some neuronal adaptation or plasticity is needed.

link to full article

Offshoring Manufacturing Facilities...

Merck goes to Ireland...

Sanofi goes to China...

Who is going to go to India?...

Regulators cite 'lack of knowledge and understanding'

A suggestion for a new SOP...

all process equipment should be cleaned at least every 5 years, or so...

The tank, in fact, was not cleaned at all between 2001 and the end of the company's April 2006 production run.

Following non-routine maintenance, the holding tank was then cleaned using ethanol according to SOP guidelines. Crucially, however, the tank was not dried afterwards to rid it of any residual ethanol.

The tank therefore still contained the alcohol when it was charged with the starting material, MSA. This resulted in a reaction that caused high levels of EMS in the Viracept starting material.

The official report into good manufacturing practice (GMP) failures that caused dangerous contamination and a Europe-wide recall of Roche's HIV drug Viracept (nelfinavir) claims the firm simply did not understand its own manufacturing processes.

The Committee for Medicinal Products for Human Use (CHMP) published its assessment yesterday, recounting the inspections and discussions that took place in the wake of the June recall and noting the "critical GMP deficiencies" that resulted in the suspension of Roche's Viracept marketing authorisation.

The European Medicines Agency (EMEA) carried out an inspection of Roche's active ingredient manufacturing facility in Basel in collaboration with Swiss regulators Swissmedic, to assess conditions at the plant where the contamination occurred.

Their examination revealed violations that not only led to the high-level contamination reported over the summer, but also led to questions regarding regular manufacturing processes and concerns over "the quality of Viracept and its safety under normal conditions of use."

link to full article

Stem cell breakthrough uses no embryos

Follow-up to the story below and others...

NEW YORK - Scientists have made ordinary human skin cells take on the chameleon-like powers of embryonic stem cells, a startling breakthrough that might someday deliver the medical payoffs of embryo cloning without the controversy.

Laboratory teams on two continents report success in a pair of landmark papers released Tuesday. It's a neck-and-neck finish to a race that made headlines five months ago, when scientists announced that the feat had been accomplished in mice.

The "direct reprogramming" technique avoids the swarm of ethical, political and practical obstacles that have stymied attempts to produce human stem cells by cloning embryos.

Scientists familiar with the work said scientific questions remain and that it's still important to pursue the cloning strategy, but that the new work is a major coup.

"This work represents a tremendous scientific milestone — the biological equivalent of the Wright Brothers' first airplane," said Dr. Robert Lanza, chief science officer of Advanced Cell Technology, which has been trying to extract stem cells from cloned human embryos.

"It's a bit like learning how to turn lead into gold," said Lanza, while cautioning that the work

link to full article

UK Dolly Creator Gives Up Cloning Method

I couldn't decide to go with a "the more things change, the more they stay the same" or a joke about "evolution"...


LONDON - The Scottish scientist who created Dolly the sheep more than a decade ago said he is abandoning the cloning technique that he pioneered, according to an interview published Saturday.

Ian Wilmut, who led the team that created Dolly in 1996, told The Daily Telegraph that he is abandoning cloning to pursue a new technique that can create stem cells without an embryo.

Wilmut's announcement could mark the end of therapeutic cloning, in which DNA is inserted into an unfertilized egg, an embryo is produced and stem cells are harvested, the newspaper said. Tens of millions of dollars have been spent worldwide on therapeutic cloning research in the past decade, but nobody has made it work in humans.

Wilmut believes a rival method pioneered in Japan that creates stem cells from fragments of skin is better for growing tissue that can be used to treat people who are paralyzed or have illnesses ranging from diabetes to Parkinson's disease.

He said the Japanese method does not require human eggs, making it "easier to accept socially" than his Dolly method, known as "nuclear transfer." The Japanese method removes the need to destroy embryos - an action many people oppose and that has become a major stumbling block for funding and regulating research.

"I decided a few weeks ago not to pursue nuclear transfer," Wilmut was quoted as saying.

link to full article

Merck tells AIDS vaccine volunteers who got jab

I have always wondered how they got people to volunteer for this type of study...

because of this exact issue...

WASHINGTON (Reuters) - Thousands of people who volunteered to test an experimental AIDS vaccine that may have actually raised the risk of infection will be told if they got the actual shot, researchers said on Tuesday.

Merck & Co. Inc. and academic researchers said they would "unblind" the study, meaning everyone would find out who got the active shot and who got a dummy injection.

Two international trials of the experimental vaccine were stopped in September after it became clear the vaccine did not prevent infection with the AIDS virus.

The trials were conducted in the United States, Peru, Brazil, Dominican Republic, Haiti, Jamaica, Australia and South Africa.

Earlier this month, researchers said they saw some worrying indications that the vaccine somehow raised the risk of infection, although they stressed the vaccine could not itself cause HIV infection.

link to full article

Not everyone is willing to take the "Snooze/ Lose" approach

to job creation...that is...

unlike New Jersey, other states are investing...

Alabama...$65 million biotech wing opens

or private investment to complement public spending...Pfizer's Biotech Center

I'm sure there are others...

New Jersey Voters Defeat Stem Cell Measure

TRENTON, Nov. 6 — In a stunning defeat for Gov. Jon S. Corzine, New Jersey voters on Tuesday rejected a ballot measure that would have permitted the state to borrow $450 million for stem cell research.

The sound defeat, coupled with the failure of another initiative that would have set aside more money for property tax rebates, marked the first time in 17 years that voters in New Jersey had defeated any statewide ballot question.

The ballot questions offered a rare surprise on a day in which Democrats maintained their control over both houses in the State Legislature. As of midnight, Democrats appeared poised to add one seat to their 22-18 majority in the Senate by winning seats in Atlantic City and Cape May Counties that had been in the hands of Republicans. In the Assembly, Republicans appeared to chip one or two seats from the Democrats’ current 50-30 majority.

But it was the defeat of the stem cell measure by a resounding 53-47 percent margin that dealt a sharp blow to Mr. Corzine, who had campaigned heavily for it and had contributed $150,000 to the effort.

Supporters had argued that the borrowing would help pay for research that could help deliver New Jersey from financial distress by bringing additional tax revenue and tens of thousands of jobs to the state. Critics, by contrast, said that New Jersey could not afford to add to the state’s surging debt load of $30 billion.

link to full article

China Biotech 2008

and China weighs in on the biotech front...

An executive report on the emerging companies, government incentives and recent investments that are defining China's burgeoning biotech industry. Plus, access to China Biotechnology database!

China Biotech 2008, a new report written by General Biologic and published by BioWorld Today, provides an unprecedented look at biotechnology activities in China. This report provides an in-depth review of the biotech industry mix (service provider, innovators and biogenerics companies), provides an analysis of the Chinese government's role in biotech, and investigates the fundamentals of success and failures present within the commercial enterprise sector.

Hundreds of new biotech companies have recently emerged in China, and several have even listed shares on the U.S. capital markets – a bold sign of things to come. Indeed, biotechnology services, innovation and generics have thrived despite a number of significant obstacles. This report reviews these obstacles and illustrates the tenacity of China's companies to succeed. We review how these different areas in China are being shaped by different forces and how each one will play an important role on the global biotech stage.

link to report page

FDA Says Consumers Continue to Buy Risky Drugs Online

Who has any reason to be doing this?...

Self-medication a concern; FDA-approved generics may be cheaper alternative

A yearlong U.S. Food and Drug Administration (FDA) investigation into drugs mailed to the United States from foreign countries suggests that consumers may be buying drugs online to avoid the need for a prescription from their physician. The FDA sampling of imported drugs also indicates that consumers continue to spend money unnecessarily on potentially risky drug products bought over the Internet.

The investigation found 88 percent of the 2,069 drug packages examined appeared to be prescription medicines available in the United States. Of the remaining products, some were dietary supplements, some were foreign products with labeling that was illegible or incomprehensible, and some were medications not available in the United States. More than half (53 percent) of the products sampled have FDA-approved generic versions, likely sold at lower costs, according to earlier studies that have shown generics in the United States to be generally cheaper than a comparable drug in Canada or Western Europe. In fact, approved generic versions of approximately half (47 percent) of the sampled products can be bought for $4 at several national chain pharmacies, a price often lower than the shipping costs for the same drugs purchased online.

"The data lead us to believe that many people are buying drugs online not to save money but to bypass the need for a prescription from their doctor since these Web sites typically do not require the purchaser to have a prescription," said Randall Lutter, Ph.D., FDA's deputy commissioner for policy. "In essence, they seem to be getting and using prescription drugs without a prescription, an intrinsically risky practice."

link to full article

Fun E Pharm

Another perfect day...

Back at the Fun E Pharm...The Series...

The real life fictional action drama documentary mini-series that dares to show us the pudgy underbelly of the Life Sciences industry...

Additional links are provided in the sidebar...




Note: Thanks to Motorhead for the insiration for the title...

Blogging ISPE 2007

Unfortunatly, I will not be in attendance this year for the ISPE Annual Meeting in Las Vegas...

coverage this year will be limited to providing links to other coverage of the event...

Updating Blogrolls...

The Blog rolls have been updated...they were not very up to date to start with, and the existing links were lost during the conversion to the new Blogger update...

A few thoughts...

1- Quantity- Wow, there are a lot more people blogging about this stuff than there used to be...A couple of years ago it was hard to find anyone else covering these topics...(although maybe I just wasn't looking hard enough)...Now you can't swing a WIP sample without hitting another Pharma blog...which is good news, I guess...the more the merrier...

2- That's Punny- There are only so many funny ways you can spin the Pharm/ Farm pun...but that certainly hasn't stopped people from trying...

3- Pharma versus Biotech- There seem to be a lot more people focused on the Pharma market than the Biotech market- Why the distinct separation???- they are converging faster than you think...

4- Corporate Blogs- Congrats to Johnson and Johnson for their "three dimensional view" blog...let's see if anyone follows suit.

IMS: US Drug Sales Will Fall 17 Percent

Maybe this article will affect the voting for the current Poll question...

WASHINGTON (AP) -- Pharmaceutical sales in the U.S. will drop to a third of global sales in 2008, from a 50 percent share two years ago, a report released Thursday says.

Prescription drugs sales in emerging economies in China, Brazil, Turkey, Mexico and elsewhere are booming but the gains will be offset by the loss of patent protection for profitable drugs worth $20 billion in annual sales in 2008, predicts health care research firm IMS Health.

Expected global sales growth of 5 percent to 6 percent, worth between $735 billion to $745 billion, in 2008 compares with 6 percent to 7 percent growth in 2006 that netted between $695 billion to $705 billion.

In the U.S., prescription drug sales growth of 4 percent to 5 percent, or $295 billion to $305 billion, is forecast by IMS Health.

U.S. patents for Johnson & Johnson's schizophrenia treatment Risperdal and Merck & Co. Inc.'s osteoporosis medicine Fosamax will likely expire, helping drive global sales growth in generic drugs of 15 percent to $70 billion.

IMS expects 29 new drugs to launch next year, but most of them will target less common diseases, not offsetting lost sales of drugs like Merck's Zocor, a widely used cholesterol-lowering drug that lost patent protection this year.

link to full article

Once-weekly diabetes treatment looking good

good news for diabetics...

A once-weekly Type II diabetes treatment has shown promise when compared to its twice-daily counterpart.

Amylin Pharmaceuticals, Eli Lilly and Alkermes have developed a long-acting release formulation of exenatide, which is currently marketed as Byetta, a twice-daily injection.

The results from a 30-week comparator study of the two products showed a "statistically significant improvement" in the A1C test, which gives a picture of average blood glucose control over a two to three month period to indicate how well diabetes treatment is working.

According to the companies, the once-weekly formulation showed an improvement in A1C of approximately 1.9 percentage points from baseline, compared to an improvement of approximately 1.5 percentage points for Byetta. Approximately three out of four subjects treated with once-weekly exenatide achieved an A1C of seven per cent or less. A1C of less than seven per cent is the target for good glucose control as recommended by the American Diabetes Association.

During the study, both treatments showed an average weight loss in the subjects of approximately eight pounds.

link to full article

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.”

link to full article

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.

link to full article

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.”

link to full article

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."

link to full article

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.

link to full article

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.

link to full article

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.

link to full article

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.

link to full article

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.

link to full article

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.

link to full article

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.

link to full article

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.

link to full article

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.

link to full article

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.

link to full article

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.

link to full article

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.

link to full article

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.

link to full article

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.


link to full article

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.”

link to full article

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.

link to full article

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.

link to full article

Drug Makers, FDA Partner on Drug Safety

TRENTON, N.J. -
A rare collaboration of top pharmaceutical companies, regulators and university researchers has begun attacking one of the toughest problems in medicine: why severe drug side effects strike a small percentage of patients.

Dubbed the International Severe Adverse Events Consortium, the project will use genetic data to try to design safer drugs and to identify patients at risk of dangerous side effects because of a variation in their genetic makeup.

"This is what personalized medicine is really about, finding out for the individual, not just the general population ... what their risks are," said Dr. Janet Woodcock, deputy commissioner for operations at the Food and Drug Administration, which is under growing pressure to ensure drugs are safe. "Up until now we've been kind of helpless" in dealing with adverse effects, she said.

Reports of such events are on the rise, jumping 150 percent from 1998 to 2005, a recent study found.

The project, to be officially announced Thursday, could bring breakthroughs that change patient care in as little as five years, the consortium's chief executive, Arthur Holden, said Wednesday. Independent experts agreed, but said the researchers will need a little luck along the way.

link to full article

Mercury-Containing Vaccine Vindicated

We all got a lot of work out of this issue...

New Research Clears Thimerosal; Some Vaccine Efforts Say Ban Was Premature

As federal health officials offer more evidence that the mercury-containing vaccine preservative thimerosal is safe, many vaccine experts say in retrospect that the U.S. Food and Drug Administration's decision to remove it from childhood vaccines may have done more harm than good by raising public fears.

And still others argue that research and funds still being spent on exploring the risks of thimerosal could be directed to more productive enterprises.

A new study published in the New England Journal of Medicine concludes that early exposure to thimerosal does not cause any neurological problems. Thimerosal, used in vaccines since the 1930s, has been a topic of controversy since the FDA banned it in 1999.

Some claim that the additive causes autism and other brain development disorders in children. But the latest study joins a growing body of literature that shows thimerosal is safe and causes no long-term negative effects on children's health.

Although no concrete evidence at the time showed that thimerosal was harmful, the Centers for Disease Control and Prevention and the American Academy of Pediatrics pushed for its elimination to quell the fears of parents who might otherwise not get their children vaccinated.

link to full article

Wal-Mart Expands $4 Drugs Program

Good morning...and welcome to your pharmacy...(smile...)...

Wal-Mart Stores Inc. is expanding its national $4 generic prescription drug program by about 10 percent, adding drugs for some new conditions.
The world's largest retailer said Thursday it has added drugs covering glaucoma, attention deficit disorder, attention deficit hyperactivity disorder, fungal infections and acne.

Two prescription birth control drugs and one fertility drug were added at $9, reflecting a higher cost that the company said could not be brought down further.

The Bentonville, Ark.-based retailer launched the $4 generics program late last year as it pushed a variety of health and environmental initiatives to counter political pressure led by union groups over its labor practices, including health insurance.

"We have taken what we do best, working with suppliers, driving costs out of the supply chain and passing those savings to our customers. Now we're applying that to health care," chief operating officer Bill Simon said on a conference call for reporters and analysts.

link to full article

Industry events in India- Interphex

I had a recent posting regarding the ISPE meeting in India...

ISPE and Bio Pharm Industry in India

I didn't find much feedback on the event on the web...

but check out Interphex India

and, even better, some coverage of the event by Outsourcing-Pharma.com...covering the keynote speech by Satish Reddy, managing director and chief operating officer of Dr Reddys

Innovation 'key' to India's pharma future

Phoenix vision for new biotech campus poised to expand

More job creation investments...

Phoenix has bulked up its vision for a sprawling new biotech campus.

A string of high-rise buildings, triple the size of the city's earlier plans, would stretch across the heart of downtown over the next 25 years.

But the looming state budget crunch could take the wind out of a $470 million pitch for the next phase of the project, which goes before the Arizona Board of Regents next week.

If approved, the spending request then moves to the state Legislature, where it may receive a rocky reception. Lawmakers may balk at the staggering price tag to build a medical-education building, a mid- or high-rise research building and a mixed-use building that would include parking.

The state has been pursuing ways to expand the state's bioscience industry for years. It is seen as a key to bring high-wage jobs to the region, expand educational opportunities and diversify the state's economic base.

link to full article

Genzyme to begin $150m expansion of Allston plant

Northeast job creation!!!

Genzyme Corp., the Cambridge biotechnology giant, is planning a ground-breaking ceremony Tuesday morning for a $150 million expansion of its Allston manufacturing plant along the Charles River.

A Genzyme spokesman said the work is expected to take two years and will boost the size of the building by nearly two-thirds, to 300,000 square feet. The additional space will be used for offices and manufacturing support, and an underground steam and electrical generation system will be added to power the facility.

The mostly glass addition at 500 Soldiers Field Road will be visible to thousands of drivers daily because of its proximity to the Massachusetts Turnpike's Allston/Cambridge on-ramp. It was designed by Architectural Resources Cambridge, the same firm that worked on the original building.

Genzyme executives plan to add 90 workers to the 400 now at the building.

Tuesday's ceremony is scheduled to feature Governor Deval L. Patrick, Boston Mayor Thomas M. Menino, and Genzyme chief executive Henri A. Termeer.

Nanotech is promising, but faces hurdles

The latest editorial from John Carroll at FierceBio, as usual, an interesting read...

Dwight Seferos, PhD, a researcher at the International Institute for Nanotechnology at Northwestern University, held a sizable audience in thrall for nearly an hour at the 13th European Federation of Biotechnology meeting in Barcelona.

He had a good topic. Researchers at the institute have used oligonucleotides--a short piece of DNA known for its ability to bind to complementary DNA--to effectively disperse nanomaterials inside a variety of cell lines. There's good potential to use this technology to dispatch nanoparticles inside a patient's body to deliver therapeutic agents, Seferos told the group. The same approach, for example, could be effective in targeting cancer cells, killing them or leaving them vulnerable to chemotherapy.

Chad Mirkin, the director of the institute and a founder of Nanosphere and NanoInk, has been a leader in using atomic force microscope tips to make nanoscale materials, putting on one atomic layer at a time as he delves into a world that is one to 100 nanometers in size.

Translating that kind of technology to the bedside won't be easy, though--particularly in Europe, where government regulators have turned a cold shoulder to expensive new therapies. That message was sent loud and clear just a few hours after Seferos wrapped his presentation.

link to full article

Scientists Find Clues to Crack Brain's "Neural Code"

New Study in Nature Suggests Timing of Electrical Pulses Is Key to Understanding How Brain Cells Communicate

NEW YORK (Sept. 11, 2007) — Decoding the complex electrical signals that brain cells use to "talk" to each other is a new and important frontier in neuroscience, one that could revolutionize the diagnosis and treatment of neurological and psychiatric disease.

Now, a multicenter team, led by a researcher at Weill Cornell Medical College in New York City, says they have uncovered a vital clue to help decode that neural language.

The groundbreaking work is published in Nature.

"We discovered that the specific timing of these electrical pulses is crucial to interpreting how the neural code works as the brain represents what it sees in the natural environment. Understanding the 'time scales' that matter to the brain gives us insight into which units of the neural code we need to focus on if we ever hope to decode it," explains lead author Dr. Daniel A. Butts, who is an Institute Fellow and instructor of computational neuroscience at the HRH Prince Alwaleed Bin Talal Bin Abdulaziz Alsaud Institute for Computational Biomedicine at Weill Cornell.

The term "neural code" may be unfamiliar to most people, but it underlies nearly everything the brain's trillions of cells do each millisecond.

"The neural code is the key to understanding the patterns of electrical impulses that neurons use to communicate. These electrical patterns allow the brain to make sense of incoming stimuli, make decisions based on that information, and coordinate its activities to carry out tasks," Dr. Butts explains.

Trouble is, right now scientists have no way of interpreting this neural language.

"It's like we're hearing Morse code, but have no training in understanding what the separate beeps and dashes mean," Dr. Butts says. "And the brain's neural code is infinitely more complex than Morse code."

Unraveling the neural code would undoubtedly be a major milestone for science.

link to full article

Stem cells show potential to repair lungs

in mice, that is...still good news...

British researchers have successfully implanted lung cells grown from embryonic stem cells into the lungs of mice in a move that may one day provide treatments for humans with severe breathing problems.

Until now, stem cells have been seen as a promising avenue for conditions like diabetes and Parkinson's disease, but respiratory ailments have not featured because of the highly complex nature of lung tissue.

link to full article

Massive counterfeit drug ring cracked

The biggest counterfeit drugs conspiracy ever to be encountered in the UK was crushed this week, as gang members were found guilty of conspiracy by a UK court following a lengthy investigation by the authorities.

The massive fake drugs operation resulted in millions of pounds' worth of bogus medicines making their way over to the UK from a network of manufacturing setups around the world.

The men under investigation were part of the UK distribution arm of a global counterfeiting ring, with the majority of the fake medicines being produced in China and India, although the operations also stretched to Pakistan, the Caribbean and the US.

The counterfeiters focused on fake versions of Merck's hair loss product Propecia (finasteride), as well as the prime earners in the drug faker's portfolio - Pfizer's Viagra (sildenafil citrate) and Lilly's Cialis (tadalafil).

link to full story

Scientists reveal DNA-enzyme interaction with first ever real time footage

Why isn't this on Youtube?...

For the first time scientists have been able to film, in real-time, the nanoscale interaction of an enzyme and a DNA strand from an attacking virus. Researchers from the University of Cambridge have used a revolutionary Scanning Atomic Force Microscope in Japan to produce amazing footage of a protective enzyme unravelling the DNA of a virus trying to infect a bacterial host.

link to full story

link to video

China recalls leukaemia drugs in safety scare

How many times are we going to see headlines like these?...

as if luekemia patients didn't have enough to deal with...

BEIJING (Reuters) - China has recalled leukaemia drugs produced by a Shanghai drug company after several children suffered side effects, the latest in a series of product safety scares to hit China, Xinhua news agency reported on Sunday.

Xinhua said "most" of the relevant drugs produced by Hualian Pharmaceutical Co had been recalled, according to the Shanghai municipal government media office.

Earlier this month, the government suspended production and sale of the generic drugs -- methotrexate and cytarabin hydrochloride.

Xinhua did not say how widely the drugs had been distributed or whether any had been exported.

Several children suffering from leukaemia in three hospitals of Guangxi Zhuang Autonomous Region and Shanghai City felt pain in their legs and some had difficulty walking after being injected with the methotrexate drug in early July, according to the report.

Investigations showed several batches of the two drugs had been contaminated during production, Xinhua said. The factories were closed pending the outcome of the investigation.

China has come under pressure from Washington and elsewhere regarding the safety of exports ranging from toys to toothpaste.

In the wake of several widely publicized product recalls, Beijing has launched a nationwide campaign to improve product quality and food safety.

Xinhua also said authorities had reprimanded dozens of factories in eastern Zhejiang province after finding that 40 percent of the children's clothing they produced did not meet quality standards.

link to full article

Betting on Nanotech Therapies

I'm hoping nanotechnology comes up with some breakthroughs...

"There's an entire wave of important therapeutics [coming] using nanotechnology," said Jim Matheson, general partner of Flagship Ventures, Cambridge, Mass., which is contributing funding for one such venture.

By packaging drugs with nano-agents that home in on tumors directly, several start-ups hope to knock out cancer cells while triggering relatively few side effects. A number of these companies plan to begin clinical trials shortly.

These companies' work represents some of the latest strategies in the long quest to better target drugs with agents known as nanoparticles. A milestone came in 1995 with the U.S. approval of Doxil, which encapsulates the chemotherapy doxorubicin into a tiny fat bubble, or liposome, and another layer of hair-like strands made from a type of rubber.

link to full article

Lab pipe caused foot-and-mouth outbreak

Tree roots???!!!...

that kind of stuff happens at my house...you wouldn't think a research lab would struggle with the same kind of issues...

How would you like to be the plumber that gets called to snake out that drain line?

LONDON - Investigators have determined a pipe at a research laboratory in southern England caused last month’s outbreak of foot-and-mouth disease, the British Broadcasting Corp. reported Wednesday.

Britain’s Health and Safety Executive found there were biosecurity lapses at the facility in Pirbright, Surrey, the BBC reported. The investigators’ official report was due to be published Friday.

The Environment Department would not comment on the report Wednesday.

The lab complex houses vaccine-maker Merial Animal Health — the British arm of U.S.-French pharmaceutical firm Merial Ltd. — and the government’s Institute of Animal Health.

Virus traces were found in a pipe running from Merial’s lab to a treatment plant operated by the government-run lab, the BBC reported, adding the pipe may have been damaged by tree roots.

Investigators found contractors working at Pirbright traveled to and from the site using a country road next to the farm where the first outbreak occurred, the BBC said.

Foot-and-mouth disease affects cloven-hoofed animals including cows, sheep, pigs and goats. It does not typically infect humans, but its appearance among farm animals can have a far-reaching economic impact.


link to full article

China persists with pharma reforms

I do not buy this at all...I think the word I'm looking for is "white-wash"

China has confirmed the target areas of planned sweeping pharmaceutical industry reforms and also handed down the latest in a string of sentences to corrupt former drug officials.

The country's State Food and Drug Administration (SFDA) has said it will place a particular emphasis on the scrutiny of the manufacturing of injectable drug products by upping the number of its staff at such production sites.

Injectable drugs are particularly sensitive to contamination and carry greater safety risks than drugs delivered by other methods and so the agency said it plans to take particular care to ensure that the formulation and ingredients and production techniques for these drugs adhere to good manufacturing practice (GMP).

In addition, the agency will crack down on wholesalers and distributors of pharmaceutical ingredients, checking the licenses of anyone who started operating as of 2006, and will also carefully monitor those involved at all stages of the supply chain of highly restricted substances, according to news agency Interfax China.

Meanwhile, the latest in a string of former drug officials has been sentenced by a Chinese court for corruption.

Zheng Shangjin, ex-head of the Food and Drug Administration in Zhejiang province, was sentenced to four years in prison, it was reported by China's Xinhua news agency.

During 2003 to 2006, Zheng received $13,245 in bribes and a car worth $76,821 from Zhejiang Kangliyuan Investment Group, the owner of owns several pharmaceutical companies who was awarded a Good Manufacturing Practice certificate by Zheng's agency in 2002 and was subsequently granted over 100 new drug certificates per year.

link to full article

Humans' DNA Not Quite So Similar

Then why do I feel so different???...

NEW YORK - People are less alike than scientists had thought when it comes to the billions of building blocks that make up each individual's DNA, according to a new analysis.

"Instead of 99.9 percent identical, maybe we're only 99 percent (alike)," said J. Craig Venter, an author of the study - and the person whose DNA was analyzed for it.

Several previous studies have argued for lowering the 99.9 percent estimate. Venter says this new analysis "proves the point."

The new work, in the latest issue of PLoS Biology, marks the first time a scientific journal has presented the entire DNA makeup, or human genome, of an individual. However, James D. Watson - co-discoverer of DNA's molecular structure - received his own personal DNA map from scientists a few months ago. And the genomes for both him and Venter are already posted on scientific Web sites.

link to full article

Greater Philadelphia Life Sciences Guide

more virtual neighbors...

lot's of good info here...

Greater Philadelphia Life Sciences Guide

FDA Considers Outsourcing 300 Jobs

I can't wait to see the action this one gets in the broader media market...

Lou Dobbs, for instance, is some one who should have a field day with this one...

WASHINGTON - The Food and Drug Administration may outsource hundreds of jobs to private companies, according to agency officials.

The government's chief health regulatory agency is reviewing more than 300 positions in more than 20 cities to determine whether they could be performed cheaper and better by the private sector. A decision is expected next month, according to FDA documents.

An initial list of positions under review included lab technicians and field office workers who work at FDA facilities where food and medical products are inspected for safety.

However, the FDA revised the list to include only administrative jobs that aren't directly involved in food safety inspections, Chris Kelly, an FDA spokesman said Wednesday.

The FDA's outsourcing effort comes amid increased public fears about the safety of imported food and other products. In July, the White House formed an Import Safety Working Group after a string of tainted products, including toothpaste, seafood and pet food, entered the U.S. from China.

link to full article

India had it going on!!!

but, apparently, some people have gotten their noses out of joint based on the outcome of some recent court cases regarding patent protection for drug discovery...

PhRMA meet OPPI, OPPI meet PhRMA...

Big Pharma hits back at Indian patent laws

link to full article

Bird Flu Mutations

Study finds key markers for bird flu change

WASHINGTON (Reuters) - Researchers have found some of the changes that a flu virus needs to become a deadly pandemic strain, and said on Tuesday the H5N1 avian influenza virus has so far made only a few of them.

They said their study can help scientists watch for the mutations most likely to make H5N1 a global threat.

David Finkelstein of St. Jude Children's Research Hospital in Memphis, Tennessee, and colleagues looked at H5N1 virus samples from people who had been infected.

They found none were anywhere near as mutated as flu viruses that caused the three most recent pandemics, notably the 1918 "Spanish flu" that killed millions worldwide.

Writing in the Journal of Virology, Finkelstein's team said they identified 32 clear-cut changes in influenza viruses that differentiated a human flu from a bird flu.

Even when H5N1 viruses infected people, each one had made one or two of these changes at the most, Finkelstein said.

"We think they need to get to 13 to be truly dangerous," Finkelstein said in a telephone interview. "We never saw anything that approached the 13 that we saw in the Spanish flu."


link to full article

Chinese Drug Quality

Recalling drug products missing the active ingredient!!!

and the explanation is "Sophisticated trans-national gangs..."!!!

Sophisticated trans-national gangs are thought to be behind the counterfeit drugs, a fast-growing multibillion dollar business.

sounds more like the trans-national gangs are the Chinese drug commpanies...

link to full article

Big Pharma Blog...

Kudos to J+J and their corporate blog JNJ BTW

We've all heard of Corporate America's arm's length relationship with the blogosphere...and the intensely conservative Big Pharma, even more so...

I think the Red Cross lawsuit will provide an excellant test case to watch, even if it turns into a "baptism by fire"... for Marc and company...and the larger corporate community...

Evolution as a treatment?

Another interesting article by John Carrol at FierceBiotech...

The article focusses mostly on the financial aspects of the firm in question...a lot of the coverage of the biotech arena is primariliy finincial in nature, who's getting another round of financing, who's entering into what drug development deal, who's getting purchased by whom...etc, etc...all good stuff, especially if you're trying to turn a buck in this industry...

Take a moment to read thru to the second half of the article or so...

The treatment in question uses successive generation of virus mutations as a methodology of treating the disease...I find this kind of stuff facinating...I may not understand it but this industry never ceases to amaze me...

This is the type of groundbreaking innovation that should have far-reaching impact beyond the specific case being mentioned here...here's hoping the research pans out...

New vaccine may beat bird flu before it starts

WASHINGTON (Reuters) - Researchers studying bird flu viruses said on Thursday they may have come up with a way to vaccinate people before a feared influenza pandemic.

Experts have long said there is no way to vaccinate people against a new strain of influenza until that strain evolves. That could mean months or even years of disease and death before a vaccination campaign began.

But a team at the National Institute of Allergy and Infectious Diseases in Maryland and the Emory University School of Medicine in Atlanta said they may have found a short-cut.

The vaccine might protect people against the mutation that would change the H5N1 avian flu virus from a germ affecting mostly birds to one that infects people easily, the NIAID's Dr. Gary Nabel and colleagues report in Friday's issue of the journal Science.

"If we can define what changes need to be made to make that jump then we can target the immune system to that spot on the virus," Nabel said in a telephone interview.

"It gives us a chance to develop vaccines or monoclonal antibodies ... to really work in a preemptive way to be prepared."

Monoclonal antibodies, often used against cancer, are engineered immune system proteins that specifically attack proteins on a tumor or, in this case, on the flu virus.

"While nobody knows if and when H5N1 will jump from birds to humans, they have come up with a way to anticipate how that jump might occur and ways to respond to it," National Institutes of Health Director Dr. Elias Zerhouni said in a statement.

link to full article

More on India and Asia...

I particularly like the name of the PWC report...Gearing up for a global gravity shift

Asian countries push big pharma boom

Industry grows at more than 35 percent, aims for $40 billion by 2015

The center of gravity for the pharm industry has always been the Delaware Valley...but you can drive up Route 1 and see the formar pharma facilities all up for rent...I guess the rent/ labor costs finally got to be too much, even for Big Pharma...

Bio is harder to determine the real center...

but nothing stays the same but the changes...

Increasing Indian Influence...

and that's not neccesarily a bad thing...

for one, I'll bet we won't have the same type of quality issues we see with other countries...perhaps the Chinese need to take a look at their neighbor for some quality lessons...

Indian law on generic drugs is upheld

NEW DELHI: Indian pharmaceutical companies can continue making low-cost generic drugs, ensuring their flow to patients in the developing world, after a seminal challenge to patent laws in India was rejected Monday.

Aid organizations declared the ruling a victory for the "rights of patients over patents," but the Swiss drug company Novartis, which filed the case, warned that the judgment would "discourage investments in innovation" and would undermine efforts by drug companies to improve their products.

Despite disagreeing, Novartis said that it was unlikely to appeal.

The test case mounted by Novartis last year asked the High Court in Madras to clarify a significant element of India's 2005 patent legislation, arguing that it breached the Indian Constitution. At issue was the question of granting patents for incremental developments.

The full text of the judgment was not immediately released, but Reuters reported that the judge said the court had no jurisdiction over whether Indian patent laws complied with the World Trade Organization guidelines on intellectual property law.

link to full article

Daily Pharma Updates from Fierce

Lot's of good info here...Fierce Pharma

and the sister publication... Fierce Biotech

East and West...

This site has recently added Google Analytics which provides reporting features on the people who visit the blog...which has lead to some interesting discoveries

Locally speaking, (by this I mean North America)the largest single source of hits is the western coast of the US, more specifically, the state of California...this is followed closely by what I consider honme base...the Delaware Valley, comprised of New Jersey, Pennsylvania, and Delaware, with activity in New York and Maryland...

Globally speaking, (by this I mean the world) the second largest geographical area for readership is India...the largest number of readers comes from the US...

While I don't think this is tied to geopgrapghy, it is reflective of the long-standing areas of activity...San Francisco, and maybe some of the new growth areas for the industry, i.e. India and China...

The data-gathering has not be going on for long enough to determine if this is a long-term trend or just a tarnsianet result of some recent posting regarding the India Chapter of the ISPE...

I'll have to keep looking at it...

Piling On to Avandia

The FDA now thinks that Avandia should be pulled from the market based on increased risks and no signifcant benefits not offered by other products...

At risk of piling on, how come this drug was on the market in the first place...

Note to manufacturer's: if you're the first, I guess the FDA will accept the risks because no other treatment is available...the bar seems to be raised, even if retroactively in this particular case, for those who follow on...

Expert: Diabetes drug should be pulled

WASHINGTON - The widely used diabetes drug Avandia should be pulled from the market because of heart risks, a federal scientist said Monday.

Those risks, combined with no unique short-term benefits in helping diabetics control blood-sugar levels, fail to justify keeping Avandia on the market, according to a copy of a slide presentation by Food and Drug Administration scientist Dr. David Graham.

The document was distributed at the onset of a daylong meeting of a joint panel of outside experts convened to consider whether the drug should be restricted to use in select patients and branded with prominent warnings or removed altogether from sale. Previously, the FDA said information from dozens of studies of the GlaxoSmithKline PLC drug points to an increased risk of heart attack.

Glaxo officials, meanwhile, disputed that claim, citing their own analyses of studies of Avandia, also called rosiglitazone.

"The number of myocardial infarctions is small, the data are inconsistent and there is no overall evidence rosiglitazone is different from any other oral antidiabetes agents," said Dr. Ronald Krall, the company's senior vice president and chief medical officer.

The FDA isn't required to follow the advice of its advisory committees but usually does.

The FDA moved up the date of Monday's meeting following the May publication of a study by The New England Journal of Medicine that generated new concerns about Avandia's safety. The pooled analysis of 42 studies revealed a 43 percent higher risk of heart attack for those taking Avandia compared with people taking other diabetes drugs or no diabetes medication.

link to full article

10 Questions: Guy Kawasaki- Moira Gunn- Biotech

good interview...Guy doesn't normally cover the biotech industry...
I'm gladd to see he didn't fall in to any of the normal boring questions...

Ten Questions with Moira Gunn: How Does an Internet Babe* Make the Leap to Biotech?

Tech Nation

FDA probing death in gene therapy trial

The human genome has not yet realized it's promise...or yeiled all it's secrets...

WASHINGTON (Reuters) - A patient who became ill following two experimental gene therapy injections for arthritis has died and U.S. health regulators are investigating the cause, officials said on Thursday.

The gene therapy trial by Targeted Genetics Corp. was placed on hold before the death, after the patient suffered a serious, unidentified health problem.

The hold means that no one else can receive the treatment, called tgAAC94, and no new patients can be enrolled in the study, the Food and Drug Administration said.

The company and the FDA said they were working to determine the cause of the death. "The investigation into the cause of the patient's illness and subsequent death is intensive and ongoing," an FDA statement said.

The incident will be discussed at a September meeting of a National Institutes of Health advisory panel, the FDA said.

Gene therapy aims to replace a faulty gene with a healthy one. Often a virus is used to carry a new gene into cells.

link to full article

FDA Regulations- the hits just keep coming...

The FDA has enough on it's plate lately...imported food inspections, drug safety, internal direction and leadership, etc. etc...without having another whole area to begin to regulate...

but that's exactly what's happening with the wonderful world of the very small...nanotechnology, for the rest of us...

FDA press release regarding regulation of nanotech issues...

The U.S. Food and Drug Administration (FDA)'s Nanotechnology Task Force today released a report that recommends the agency consider developing guidance and taking other steps to address the benefits and risks of drugs and medical devices using nanotechnology.

It looks like it's gonna be busy times at the FDA...

enjoy...

My Recent Mail- Drug Safety Information

I got an e-mail from Karl Uhlendorf of the Pharmaceutical Research and Manufacturers of America (PhRMA) organization with a link to their website, PhRMA.org

Karl's e-mail indicated that new information had been added to the site regarding drug and patient safety...

While this does represent the industry viewpoint, and I'm sure there are plenty of people out there who will disagree, I am glad to see this issue being addressed...

Drug safety needs to be our prime focus, no matter what part of the industry you represent...

Drug Safety Issues

A good editorial piece by John Carroll over at Fierce Biotech regarding indivduals in the medical profession and drug safety...

Pharma's love/hate relationship with Dr. Nissen

I think we've all been focused on China's food and drug safety issues lately. Let's not forget that it's real issue here at home...the influence of big pharma, the regulators, and certain high profile individuals like Dr. Nissen all play a part...dare we include Michael Moore?

the pharma blogosphere is certainly filling up with other people interested in commenting; but that's a whole 'nother issue...

Governor files $1B biotech bill

Massachusetts Governor Deval Patrick (D) has filed a 10-year, $1 billion biotech investment bill designed to help the state keep its lead in the industry. At the center of the proposal is $500 million in capital funds to build the world's largest stem cell bank, which would contain 30 stem cell lines available to both the public and private sectors. In addition, the bill calls for an RNAi center to expand on the work of Nobel Laureate Craig Mello. The bill also calls for $25 million a year for research and training grants and an additional $25 million in tax incentives for the industry.

"With this legislation we can begin a robust stage in our own long march toward investment in innovation and infrastructure throughout the region and in every region of the Commonwealth," the governor said. "We want to create a pipeline of ideas to cures, from inspiration to commercialization." Patrick first announced the funding at BIO 2007 in May. Massachusetts lawmakers expressed support for the bill but worried that the price may be too steep.

link to full article

Biotech manufacturing jobs are desirable

San Diego County's biggest biotech manufacturing plant is officially in business. Biotech giant Genentech Inc. is also providing hundreds of well-paying jobs and boosting North County's economy.

The plant, bought for $408 million by Genentech in 2005, recently received government approval to make Avastin, its blockbuster cancer drug.

A building that looks like many commercial office buildings, the plant has something very different at its core ---- huge, spotless metal fermentation tanks resembling those found in a brewery. The tanks are so large that they begin on one floor and end on another.


These carefully monitored tanks, deep within the building and not open to the public, are now fermenting Avastin, far more valuable than beer. Avastin, which treats colorectal cancer, brings Genentech sales of $1.7 billion a year.

The plant, in eastern Oceanside, is expected to help Genentech, based in South San Francisco, bring in even more revenue. Its tanks have a capacity of 90,000 liters, one-third of Genentech's Avastin manufacturing capacity.

This plant, which employs 590, adds the last element missing from the region's biotech industry: large-scale commercial drug manufacturing. Local scientists have long researched drugs here. But production was usually handled by a large pharmaceutical partner that manufactured elsewhere. Local business leaders want those jobs, which pay much more than typical manufacturing jobs.

link to full article

When it Comes to Walking, it's all Good, Says Mayo Clinic Researcher

Maybe I'm not as crazy as I seem, when I'm out walking at lunch...

ROCHESTER, Minn. -- These days, it's easy for people to get confused about exercise -- how many minutes a day should they spend working out, for how long and at what exertion level? Conflicting facts and opinions abound, but one Mayo Clinic physician says the bottom line is this: walking is good, whether the outcome measurement is blood pressure, diabetes, cardiovascular disease, joint problems or mental health.

"Getting out there and taking a walk is what it's all about," says James Levine, M.D., Ph.D., and a Mayo Clinic expert on obesity. "You don't have to join a gym, you don't have to check your pulse. You just have to switch off the TV, get off the sofa and go for a walk."

The health benefit associated with walking is the subject of Dr. Levine's editorial in the July issue of Mayo Clinic Proceedings. Dr. Levine's piece is entitled, "Exercise: A Walk in the Park?" and accompanies a Proceedings article that showcases the merits of walking as beneficial exercise.

link to http://www.mayoclinic.org/news2007-rst/4133.html

Life Sciences Greenhouse of Central Pennsylvania

sometimes our virtual neighbors are on the other side of the world...
sometimes they're next door...

like the Life Sciences Greenhouse of Central Pennsylvania

I normally don't post much above the financial aspects of the industry, others do that so much better...but this site is paid for by the tobacco industry, so I'm good to go with it...



I am a bit surprised by their geographical limitations...