Finally, a reason to start drinking alcohol

As if you needed one...

WASHINGTON (Reuters) - People who do not drink alcohol may finally have a reason to start -- a study published on Friday shows non-drinkers who begin taking the occasional tipple live longer and are less likely to develop heart disease.

People who started drinking in middle age were 38 percent less likely to have a heart attack or other serious heart event than abstainers -- even if they were overweight, had diabetes, high blood pressure or other heart risks, Dr. Dana King of the Medical University of South Carolina in Charleston and colleagues found.

link to full article

March Madness...

It's that time of year again...only in Philly...

Interphex

March 26-28...

The Baxter Heparin Saga...pick your spin...

There are a lot of different ways to look at this issue...

- Writer's Scare Tatics..."Tampering possible in China"

- Troubleshooting drug safety is scientific challenge...heparin-like molecules

- FDA and manufacturer cooperate to maintain drug supply...Earlier this month, the firm stopped production, but the FDA wanted to keep the existing Baxter heparin in doctors' hands because it did not want to cause a shortage of the life-saving drug. Agency officials said increased production by the other heparin manufacturer can now satisfy the demand.

- FDA doesn't inspect overseas manufacturing sites...The FDA has averaged just 15 inspections in China in each of the last five years

- Lack of FDA oversight on imports...Flood of drugs, little oversight by regulators

- Outsourcing causes quality problems...Baxter’s Heparin Problems May Have China Connection

- Chinese quality control...Baxter tests point to Chinese problem

- Realtime crisis management...Call to action at Baxter

Manufacturer intitiates recall...Baxter Issues Urgent Nationwide Voluntary Recall of Heparin

Before you decide on which drum you think should be beat on, just remeber that these issues are harder to solve than you might think...

Operation Jupiter rains on fake antimalarials

anti-counterfeiting operations...sounds exciting...

A multinational, multidisciplinary initiative involving scientists, public health workers, police and government officials could provide a cogent model for rooting out and stamping out counterfeiting of essential and lifesaving drugs.

But replicating 'Operation Jupiter', which employed a battery of forensic tests ranging from mass spectrometry to palynology (pollen analysis) to track down a source of fake artesunate in southern China, would require technical capacity and resources as well as collaborative efforts that at present are sorely lacking in the countries most affected by counterfeiting.

In the developed countries where fake pharmaceuticals are still at a relatively low ebb, counterfeiting can infiltrate a wide range of drugs, but in particular lifestyle products such as the erectile dysfunction treatments Viagra (sildenafil citrate, Pfizer) and Cialis (tadalafil, Eli Lilly).

The focus of the operation co-ordinated by the World Heath Organization's (WHO) Western Pacific Regional Office, the International Criminal Police Organisation (INTERPOL) and the Wellcome Trust-University of Oxford South-east Asian Tropical Medicine Research Programme, in close co-operation with the Chinese authorities, was a generic medicine for a tropical disease that threatens some 40 per cent of the world's population and still claims over a million lives a year.

link to full article

FDA plans new post-approval drug safety effort

A step in the right direction...Hopefully the FDA will start to knock these issues off one at a time...hopefully, the follow-through doesn't bog down in bureaucracy...

WASHINGTON (Reuters) - The U.S. Food and Drug Administration is launching a new effort meant to strengthen its oversight of prescription drugs after they win approval, an agency official said on Tuesday.

The plan, called "Safety First," includes creation of a new database of possible side effects from medicines, plus clear schedules for following up on concerns about them.

The effort was first reported by the Wall Street Journal. FDA spokesman Christopher DiFrancesco confirmed the information in the Journal's story.

The action is the FDA's latest move to address charges that the agency has been slow to respond to potential side effects that emerge after a medicine reaches the market.

link to full article

Novel genetic technique 'creates' stem cells

Scientists can now transform adult cells to a stem cell-like state without using a cancer inducing gene. Researchers at Harvard University said they can now map the stages of the reprogramming which had thus far been a mystery.

"By defining cellular intermediates of the reprogramming process, our work provides reference points for understanding the molecular mechanisms underlying pluripotent (iPS) cell generation," said Dr. Matthias Stadtfeld, one of researchers on the project.

"For example, one can now take the whole reprogramming process apart into different stages and ask what enzymes or genes are important for the different stages to be initiated and completed."

The team at Harvard Stem Cell Institute and Massachusetts General Hospital have been studying the conversion of mouse adult cells to embryonic-like states by using four genes. The general way to induce iPS cells is to use cancer causing genes to initiate the process and use retroviruses to insert the genes into the target cells - retroviruses which could activate the cancer cells. The use of either oncogenes or retroviruses would make it impossible to use these cells in patients.

link to full article

Baxter unaware plant not inspected

Baxter International Inc. does not monitor its supply chain to the extent that it would know that a supplier in China was never inspected before it began shipment of the blood-thinning drug heparin, which is linked to more than 300 illnesses in the U.S., the company's chief executive said Wednesday.

Baxter contracted with a Wisconsin supplier, Scientific Protein Laboratories, and not with that company's Chinese affiliate, Baxter CEO Robert Parkinson said Wednesday in his first interview since the heparin problems surfaced.

"It's not unusual for us not to know that the FDA hasn't inspected a supplier to a supplier," Parkinson said.

Deerfield-based Baxter's troubles with heparin highlight the concerns many U.S. companies and consumers have about their vulnerability to errors by suppliers from China and other less-developed countries. Problems with tainted toys, toothpaste, tires and pet food from China in the last year preceded Baxter's issues with heparin, made from an active ingredient imported from China.

link to full article

Amgen calls Roche 'snake-oil salesman'

I can't wait for the response...in the headline of the Street Journal...

"and you're a big doo-doo head!!!...so there..."

No way, Roche. Amgen rejected a royalty offer from the Swiss drugmaker, which wants to sell an anemia drug that would compete against Amgen's signature blockbusters. Mircera, Roche's version, was approved by the FDA in November, but a jury ruled that the drug would infringe on Amgen's patents. Despite a juicy royalty offer of some 20 percent--twice that paid by Johnson & Johnson for its Procrit med--Amgen is holding fast.

In fact, according to court documents, the California company is scrapping for the fight. After likening Roche to a "snake-oil salesman," Amgen says in court documents, "The only thing more astonishing than Roche's false assertions of its public interests is it chutzpah now in proposing that the Court order a license at a royalty rate of 20 percent."

link to full article

FDA Says It Approved The Wrong Drug Plant

and things go from bad to worse...

sometimes the last thing you want to do is find out what is really going on...'cause it might be scary to contemplate...

Heparin Probe Sends Inspectors to China

The Chinese facility that supplies the active ingredient of the widely used blood thinner heparin was never inspected by the Food and Drug Administration because the agency confused its name with another just like it, agency officials said yesterday.

The FDA said that a team of inspectors is headed now to China to inspect the plant as part of an effort to determine what may have caused a sudden spike in serious problems with the drug, which has been on the market since the 1930s.

link to full article

Congressman: FDA chief should resign

Now that Congress has solved the "steriods in baseball issue", they can move on to bigger and better things...

politicizing the FDA!!!...

The heparin pile-on has begun--but this time, the FDA is at the bottom, not the drugmaker. As Baxter analyzes product samples for impurities that might have caused 350 adverse reactions, including four deaths, Congress and other critics are pointing fingers at the watchdog agency. And the FDA itself admits that yes, it violated its own procedures in approving the drug for sale without inspecting the Chinese plant where its active ingredient was made. One key Congressional critic is even asking FDA chief Andrew von Eschenbach to step down.

Baxter, of course, isn't getting off scot free. Its internal investigation is squarely under the media spotlight. So far, the company has found some differences between problem heparin vials and controls, and some of the differing samples did come from China. But so far, said a company spokeswoman, "[I]t's unclear what the impact of these differences is."

Baxter also ID'd the supplier in question, which it had refused to do before. The API maker is Scientific Protein Laboratories, a Wisconsin company that makes bulk heparin at a Chinese factory and at another at HQ. SPL says both plants adhere to the same industry and FDA safeguards. The agency is prepping an inspection team to check out the Chinese plant, and Baxter plans to send its own investigators. But plant personnel know inspectors are coming. "We'll fully cooperate," said a quality-control manager at the Chinese plant.

The big question posed by lawmakers and consumer advocates alike: With most bulk drug ingredients made overseas now--and only 7 percent of foreign plants inspected a year--what else is falling though the cracks? Some even want lawmakers to bar Chinese-made pharma ingredients. "China is fundamentally incapable of safeguarding...safety and efficacy," one business ethicist told Pharmalot.

link to full article from fiercepharma

China Plant Played Role

I am glad to see that the FDA will be inspecting this facility "soon"...

I was discussing this issue with a colleague the other day...we had noted that the vials produced at the plant had tested negative for contaimination and endotoxins...with that infromation, the person I was discussing this with said something alog the lines of "Mark my words, there will be an issue with one or some of the ingredients coming from oversees..."


A Chinese facility that hasn't been inspected by the U.S. Food and Drug Administration made the active ingredient in much of the widely used Baxter International Inc. blood-thinner that is under investigation after reports of hundreds of allergic reactions and four deaths among the drug's users, the agency said yesterday.

The disclosure is likely to add to broad concerns about the safety and quality of products imported from China and elsewhere in the developing world. A tide of tainted goods ranging from pet food to children's toys has prompted recalls and increased scrutiny of Chinese-made wares around the world.

Although it isn't known whether the Chinese plant played a part in the drug's problems, its role as a supplier to Baxter is expected to fuel questions about U.S. regulators' ability to ensure the safety and quality of imported drugs and drug ingredients.

On Monday, Baxter announced that it had temporarily halted production of its version of the generic anticlotting drug heparin because of about 350 bad reactions potentially tied to the drug, including four fatalities, primarily in patients undergoing kidney dialysis and heart surgery.

Yesterday, both Baxter and the FDA said it wasn't clear that the ingredient from the Chinese supplier was tied to the bad reactions. "We honestly don't know" the cause, an FDA spokeswoman said.

link to full article

Governor visits Carlsbad to tout biotech industry

biotech as job creation...one of my favorite issues...go arnold...

As the state economy sputters, Gov. Arnold Schwarzenegger was in Carlsbad yesterday to shine the spotlight on biotechnology, an industry that is growing.

“We are here today to talk about job creation,” Schwarzenegger said after touring a stem cell lab and manufacturing facilities at Invitrogen, a publicly traded biotechnology company that makes tools for drug-discovery research.
While the state's unemployment rate has climbed to 6.1 percent, biotechnology has continued to sprout and grow, he said. Invitrogen, for example, has grown 5.5 percent in the past year and is expanding its manufacturing capacity by 50,000 square feet and hiring an additional 200 workers, Schwarzenegger said.
In California, 240,000 people are employed in 5,500 life-science companies, which include those that make therapies, medical devices, diagnostics and tools. The industry attracted $3.2 billion in venture-capital investment last year, which was half the nationwide total, the governor pointed out.
And California's $3 billion investment in stem cell research, known as Proposition 71, is helping research institutes attract the best and brightest talent from around the world and fuel potentially lifesaving research, he said.
Schwarzenegger said he wanted to use his appearance at Invitrogen for a round-table discussion with the region's business leaders. Specifically, he wanted to know what state government could do to further support the health and growth of an industry that provides high-skilled and high-wage jobs and is expected to continue growing for many years.
In the San Diego area, the biotech industry returned $8.5 billion to the economy, state Labor Secretary Victoria Bradshaw said.

link to full article

FEP Update

Invasion of the Document Snatchers- the Aftermath continues- The Quarterly Review

FDA looks for "boots on the ground" in China

First it was India...now China...

WASHINGTON (Reuters) - The United States is hoping to bolster the safety of food and other products imported from China by opening a new Food and Drug Administration office in the Asian nation.

"We will be able to continue to expand our own ability to leverage, beyond simply sending inspectors over, but to have people in place," FDA Commissioner Andrew von Eschenbach said during the Reuters Regulatory Summit here.

"We're boots on the ground," he said.

FDA officials see the office, which must be approved by the Chinese government and funded by Congress, as a model for outposts elsewhere, which in an era of globalized trade would shift much of the burden for safe imports to producer countries instead of relying on inspections at home.
Von Eschenbach said FDA officials in China, rather than regularly patrolling factories, would seek to create more stringent safety standards among producers and would look to strengthen regulation by Chinese government.

Basing officials in China would also allow the FDA to move quickly when problems do arise, rather than having to secure visas or make long trips before setting off to inspect problem facilities.

link to full article

US FDA budget seeks biotech generics, user fees

People are starting to talk about the impact of the political system on the FDA...

Not good to see this function impacted by politics...


WASHINGTON, Feb 4 (Reuters) - New fees for the Food and Drug Administration to speed review of generic pharmaceuticals and new authority to approve copycat versions of some biotech drugs were proposed in President George W. Bush's budget on Monday.
The White House requested an FDA budget of $2.4 billion for the 2009 fiscal year starting in October, a 5.7 percent increase over last year's budget.

The proposal comes as the FDA faces heightened criticism for inadequate staffing, lax oversight of drug and food safety and out-of-date technology. Last week, lawmakers met to discuss a report by an independent board that concluded lives are at risk because the agency is so underfunded and behind in cutting edge science.

"It's pretty disappointing, especially in light of the overall unanimity of concern over food safety and drug safety," said Bill Hubbard, an advisor to the Alliance for a Stronger FDA, and former associate FDA commissioner from the early 1990s through 2005. The Alliance is made up of industry, and consumers and patient groups.

Hubbard said that because FDA's costs are more aligned with medical costs, which are rising faster than overall consumer inflation, "it's barely half of what FDA needs just to keep pace with inflation."


link to full article

New Alzheimer's theory gains NASA backing

More cool stuff from NASA...I didn't know they did this kind of research...

A controversial new theory on the origins of Alzheimer's has divided opinion in the medical world, but if proved right could 'revolutionise' treatment.

Dr Shaohua Xu of Florida's Space Life Sciences Laboratory at Kennedy Space Center (KSC) and of Florida Tech has earned a $150,000 grant from Space Florida and a $30,000 cash injection from NASA's Aerospace Medicine and Occupational Health Branch to test his theory.

Conventional wisdom dictates that when tau protein joins together to form tangled fibres at the start of Alzheimer's, each tau molecule join to the fibre's tip. However, Xu has a different idea."

We find that it is a three-step process," he said. "First, molecules of the tau protein cluster together into spheres, each almost the same size. Next, the spheres join together in linear chains like beads on a string. In the third stage the beads merge together to form a uniform filament identical to those found in the brains of patients with the disease."

Using atomic force microscopy, Xu has been using purified protein to synthesis the fibres into their various forms. He first developed his theory over a decade ago. "

Shaohua's theory is revolutionary; his evidence is overwhelming. The medical implications are beyond anything in my experience," said advocate Dr Daniel Woodard at KSC, who was the first medical doctor to review Xu's work."

This could be the most important biomedical discovery ever made at Kennedy Space Center," echoed NASA physician David Tipton, chief of the Aerospace Medicine and Environmental Health Branch at KSC.

link to full article

Pot Vending Machines in LA

Now all we need to do is worry about the cancer cases...

LOS ANGELES (AP) — The city that popularized the fast food drive-thru has a new innovation: 24-hour medical marijuana vending machines.
Patients suffering from chronic pain, loss of appetite and other ailments that marijuana is said to alleviate can get their pot with a dose of convenience at the Herbal Nutrition Center, where a large machine will dole out the drug around the clock.
"Convenient access, lower prices, safety, anonymity," inventor and owner Vincent Mehdizadeh said, extolling the benefits of the machine.
But federal drug agents say the invention may need unplugging.
"Somebody owns (it), it's on a property and somebody fills it," said DEA Special Agent Jose Martinez. "Once we find out where it's at, we'll look into it and see if they're violating laws."
At least three dispensaries in the city, including two belonging to Mehdizadeh, have installed vending machines to distribute the drug to people who carry cards authorizing marijuana use.
Mehdizadeh said he spent seven months to develop and patent the black, armored box, which he calls the "PVM," or prescription vending machine.
A sliding fence protects the tinted windows of his dispensary, barely distinguishing it from a busy thoroughfare of strip malls, automobile dealers and furniture shops. A box resembling a large refrigerator stands inside the nearly empty shop, near a few shelves stocked with vitamins and herbs.
A guard in a black T-shirt emblazoned with the word "Security" on the front stands at the door. A poster of Bob Marley decorates a back room.
The computerized machine requires fingerprint identification and a prepaid card with a magnetic stripe. Once the card and fingerprint are verified, a bright green envelope with the pot drops down a slot.

link to full article

5 Cool Things You Can Do With Your DNA

5 Cool Things You Can Do With Your DNA

Vaccine for drug addiction could offer hope to users

From bad news to good...

CHICAGO (AFP) - In a search for what could be the ultimate cure for drug addiction, scientists have developed a vaccine which prevents the body from getting high.

The hope is that it can stop people from falling back into a spiral of addiction if they have a relapse.

The most promising results so far have been with cocaine, but researchers hope it could also one day be used to cure addiction to methamphetamine, heroin and even cigarettes.

"The vaccine slowly decreases the amount of cocaine that reaches the brain," said Thomas Kosten, a professor of psychiatry and neuroscience at Baylor College of Medicine in Houston, who has been working on the vaccine since 1995.

"It's a slow process, and patients do not go through any significant withdrawal symptoms."
The vaccine works by getting the body's immune system to recognize the drug as foreign and attack it in the blood stream.

It does so by injecting an altered version of the drug into the body which has been attached to a protein that the body will recognize as a threat.

link to full article

Good News, Bad News, and Worse News...

The Good News...(for people who don't like needles)

New Flu Vaccine May Not Need Needles


The Bad News...(for diabetics)

Coffee Bad For Diabetics, Study Suggests


The Worse news...(if you smoke dope)

Cannabis Bigger Cancer Risk Than Cigarettes

F.D.A. Plans to Post Inspectors Overseas

Guess you won't need to buy a house in Virginia if you work for the FDA...

WASHINGTON — The Food and Drug Administration intends to post inspectors to embassies and consulates throughout the developing world in hopes of improving the quality of the food and medicines increasingly flowing to the United States, a top official said Thursday.
The agency’s commissioner, Dr. Andrew C. von Eschenbach, said that he wanted to have “boots on the ground” in nations like India and China and regions like Central and South America and the Middle East.
The agency already sends inspectors to dozens of countries each year to inspect pharmaceutical plants and clinical trial sites. But Dr. von Eschenbach said in a briefing with reporters that he wanted the agency’s presence abroad to be on an “ongoing and continuous basis rather than episodic and periodic.”
“Right now, we come, we leave,” he said.
The inspectors would primarily “build capacity and bring others in to do inspections that are certified,” Dr. von Eschenbach said.

link to full article

JNJ Blog and the Corporate Membrane...

There have been some posts recently about various companies and the moves to set up shop in India...see previous posts here and here...and even the FDA...see post here...

Quite frankly, some of these moves seem to be born from panic, or more likely the corporate smokescreen executives put out to demonstrate "our new strategic direction" when all they really have is a desperate attempt at cost-cutting, which, in all likelihood, will wind up costing the corporation more...but that won't stop them from flailing away, or collecting the bonus they so richly deserve...

So what does this have to do with corporate blogging?

Recent articles regarding JNJ activity in India can lead you to their blog, JNJBTW...there you might find some recent posts regarding their history in India... not bragging, just giving out interesting tidbits... like the fact that JNJ has had interests in India since 1947...

Other links take you to the backstory of worldwide travel by the Johnsons to develop global strategies for corporate growth...interesting, but does this have anything to do with what JNJ is currently thinking?

It turns out it might, if you read about the latest efforts to develop growth strategies for the next 40 years...

the blog posts, the articles, the backstory...it all adds up to a coherent story about what JNJ is doing and why...available to anyone who wants to spend a few minutes on the web...which you were doing anyway, by the way...

the corporate membrane can be porous...

absent this infromation, you would be forced to draw your own conclusions about whether a company moving overseas was part of a coherent strategy, or just an act of desperation...JNJ does a pretty good job of making their case...I don't think the same can be said for all those other companies in such a rush to get to India...

California Employers Can Fire Medical Marijuana Users

I thought this article would be funnier than it actually turned out to be...I especially like the part about "not during working hours..."

The California Supreme Court ruled 5-2 Thursday that an employer can fire an employee who tests positive for marijuana, even if the worker has a note from a doctor stating the drug is needed for medical reasons.

The ruling comes in a lawsuit filed in 2002 by Sacramento attorney Stewart Katz on behalf of Gary Ross, a former systems administrator at RagingWire Telecommunications who suffers from chronic lower back pain and muscle spasms.

Ross first tried to treat his condition with muscle relaxants and traditional pain medications, but when these conventional medications failed to provide relief, his doctor recommended marijuana. Although Ross was a qualified patient under the Compassionate Use Act, approved by voters in 1996, he was terminated from his job at RagingWire in 2001 after a drug test showed detectable amounts of marijuana in his system.

He sued in 2002 for wrongful termination in violation of public policy, employment discrimination and breach of contract -- and lost at the trial court and appeals court levels before petitioning for review by the state's highest court.

The majority opinion Thursday noted the Compassionate Use Act makes no reference to employment law, so the court cannot rule on those grounds. The wrongful termination claim doesn't work either, the court said, because the employer's action can't be against public policy when marijuana use is against federal law, even with a prescription.

"Today's decision is a victory not only for employers, but for workers and customers of companies who want to be assured of a drug-free workplace," Deborah LaFetra, an attorney with the Sacramento-based Pacific Legal Foundation who filed a friend-of-the-court brief in the case, said in a statement. "

Drug-using employees are known to have impaired abilities, both mental and physical, that can alter their judgment and other necessary skills for their work. This decision promotes employer efforts to make safe, drug-free workplaces."

link to full article

'World's best microscope' up and running

I want one!!!...

The world's most powerful transmission electron microscope has been turned on in the US, with single-atom resolution bringing within reach the ability to analyse chemicals simply by looking at them.

The Transmission Electron Aberration-corrected Microscope (TEAM 0.5) has been installed at the Lawrence Berkeley National Laboratory, having been developed in collaboration with the US Department of Energy (DOE), the University of Illinois and two microscopy firms: the FEI Company and Germany's CEOS.
Traditionally TEM and scanning TEM microscopes have suffered from somewhat limited resolution that stopped frustratingly short of allowing researchers to study materials accurately at the atomic level. This latest development has managed to reach a resolution of 0.5 Angstroms (A) (0.05nm) or one quarter of the diameter of a carbon atom.
The increased resolution of the TEAM microscope should enable scientists in all disciplines to characterise atomic scale structure and chemistry more accurately than ever before.

The director of the TEAM Project, Uli Dahmen, explained that the microscope is the world's best thanks to the equipments resolution, improved contrast and low signal-to-noise ratio.

"[It] brings us within reach of meeting the great challenge posed by the famous physicist Richard Feynman in 1959: the ability to analyse any chemical substance simply by looking to see where the atoms are.

link to full article

FDA considering establishing Indian presence

Can this even be considered out-sourcing???...

The US Food and Drug Administration (FDA) is considering establishing a presence in India, amidst the country's growing ties with the US pharma industry.

FDA commissioner Andrew Von Eschenbach and US Health and Human Service (HHS) secretary Michael Leavitt have been visiting India to assess the manufacturing practices at some of the facilities there. The visit was largely initiated in response to mounting apprehension over the quality of both food and drugs and related ingredients being imported into the US. The current import protection system was described by Leavitt as "inadequate."

Some Indian media reports have also claimed that the visit was made because the FDA is planning on setting up an office in the country. On the flip side, other media reports have said that the FDA is not planning such a move. Outsourcing-Pharma.com confirmed with an FDA spokesperson that at this point the agency is just offering advice and guidance to the Indian authorities who are looking at setting up a regulatory body that is comparable to that of the FDA.

During his trip to India last week, Leavitt stated: "Basically, we would be glad to try to provide technical assistance to the Indian government as it further develops its new regulatory agency/ies."

He also said that "we are considering trying to establish an FDA presence/office in India," although no decision has been made as yet, the spokesperson advised.

link to full article

Nanoparticles Generate Supersonic Shock Waves to Target Cancer

I read the following article and found myself wondering how explosions were going to be used to treat cancer...I guess it's going to be a nanotech world...

By mixing nanomaterials that act as fuel and oxidizer, researchers have created a combustible nano explosive that can generate shock waves with Mach numbers up to 3.

The team of researchers, a collaboration from the University of Missouri-Columbia (UMC) and the U.S. Army, hope that this nano-sized “smart bomb” can target drug delivery to cancer cells, and leave healthy cells unharmed. Their study is published in a recent issue of Applied Physics Letters.

"Nanoengineered thermites can produce shock waves, and their properties are similar to some primary lead-based explosives,” Shubhra Gangopadhyay, Professor of Electrical and Computer Engineering at UMC, told PhysOrg.com. “Hence these materials may be able to replace lead-based primary explosives. We are also able to integrate this material with micro-chip technology and produce shock waves using these compact micro-chip systems. This micro system has many applications in defense, as well as in life sciences, such as targeted drug and gene delivery.”

link to full article

2007 FDA approvals

I haven't seen these numbers in a couple of years...

As has been pointed out on many occasions, 2007 was a lean year for new drug approvals. The FDA approved only 15 new molecular entities (NMEs) last year--17 if you include two new biologics (Soliris and Mircera) OK'd by CDER. NMEs are perhaps the most important form of approval because they have never been approved by the FDA in any other form. The dearth of NMEs has industry watchers thinking that pharma's pipeline may be drying up, or that the FDA is getting stricter with its approval process--or both.

Many candidates missed the final goal last year, but here's a look at the drugs that made it through the rigorous drug discovery process and earned FDA approval in 2007.

link to full article from FiercePharma

Sartorius Stedim inks deal, closes Bethlehem plant

I had recently toured this facility as part of an ISPE meeting...it is a great facility with some great people...very sad to see it close...

Processing specialist Sartorius Stedim Biotech today announced a cooperation and supply deal with systems manufacturing firm Paul Mueller Company for the US market, with a production facility in Pennsylvania set to close as a result.

Paul Mueller will take over manufacture of stainless steel biopharmaceutical production systems for Sarorius Stedim, with the agreement announced this morning covering the US, Canada, the US Virgin Islands and Puerto Rico. Effective immediately, the company will be Sartorius Stedim's exclusive North American partner and supplier of stainless steel systems such as fermentors, bioreactors, freeze-thaw systems, crossflow and other filtration systems.

As part of the move to link with Paul Mueller, Sartorius Stedim has announced plans to shut down its existing production facility for stainless steel systems in Bethlehem, Pennsylvania.

The site is relatively new, with the 85,000 sq. ft facility having only opened in October 2004. The plant employed 130 staff when it opened, with the addition of the Pennsylvania site setting Sartorius up as the only fermenter manufacturer in the world to have its own production facilities in the three key markets of North America, Europe and Asia Pacific.

Sartorius merged with French firm Stedim Biosystems just under a year ago, with the combined firm now deciding to focus on its 'customer-specific application engineering' and installation and servicing of its stainless steel systems.

These activities will take place at the company's site in Springfield, Missouri, in close proximity to the Paul Mueller operations.

The company will continue to manufacture processing systems for its European and Asian customers at its facilities in Germany and India.

link to full article

Researchers Restart Rat Heart

This story is a bit creepy, actually

There are other companies pursuing similar ideas...Tengion , for instance, is making good progress...

WASHINGTON (AP) — Researchers seeking new treatments for heart disease managed to grow a rat heart in the lab and start it beating.

"While it still sounds like science fiction, we've hopefully opened a new door in the notion that we can build these tissues and one day provide options for patients with end-stage disease," said Dr. Doris Taylor, director of the Center for Cardiovascular Repair at the University of Minnesota.

"We're not there yet, but at least now we have another tool in our tool belt."

Taylor led the team whose research appeared in Sunday's online edition of the journal Nature Medicine.

Scientists have worked for years for ways to grow body parts. Many efforts have focused on heart valves as an alternative to the plastic or animal valves that wear out after being implanted in humans.

An estimated 5 million people live with heart failure and about 550,000 new cases are diagnosed each year in the United States. Approximately 50,000 die annually waiting for a heart donor.

Taylor said in a telephone interview that her team began by trying to determine if it were possible to transplant rat heart cells. They took the hearts from eight newborn rats and removed all the cells. Left behind was a gelatin-like matrix shaped like a heart and containing conduits where the blood vessels had been. Scientists then injected cells back into this scaffold — muscle cells and endothelial cells, which line blood vessels.

The muscle cells covered the matrix walls and lined up together, while the endothelial cells found their way inside to coat the blood vessels, she said. Then the hearts were stimulated electrically.

"By two days we saw tiny, microscopic contractions, and by seven to eight days there were contractions large enough to see with the naked eye," she said. The tiny hearts could pump liquid at about one-fourth the rate of a normal fetal rat's heart.

link to full article

Research Coast a 10-year project?

I saw the headline that read "10 Year Biotech Project" and thought "Now, That's a Project!..."

read on for the real story...

PORT ST. LUCIE — The Research Coast is a sprint against other biotech hubs to land more companies.

It will take longer to generate local jobs at Oregon Health & Science University's Vaccine and Gene Therapy Institute, which announced Tuesday it would create a center at Tradition.

"It took 60 years to create the Research Triangle (in North Carolina). We're going to make that happen in a little less than 10 years," said state Sen. Ken Pruitt, R-Port St. Lucie. "This is about our kids and, when you run a relay race, you run as fast as you can."

The Senate president foresees big returns from the institute's arrival and the opening of Torrey Pines Institute for Molecular Studies. California-based Mann Research Center intends to build a $100 million, 400,000-square- foot life sciences complex next to the two research firms in the Florida Center for Innovation at Tradition.

The numbers are lofty.

The state and city are putting up $117.9 million for the Oregon institute.

In return, economic development leaders say that the 200 jobs spawned during the next decade by the institute will grow into 1,466 positions directly and indirectly through spin-off companies in the next two decades.

Those workers will generate $2 billion in payroll and $4.2 billion in gross state products.

link to full article

Teva earmarks $1bn for India plans

Teva continues to set the pace...it seems a lot of companies stand the possibility of being out-maneurvered...

The world's generics titan, Teva, has reportedly earmarked over $1bn to fuel an ambitious plan to broaden its presence in India.

Over the next two years the firm is intending to use $250m-$300m to build new generic ingredients manufacturing facilities in the country.The first of these planned constructions is imminent, with company preparing to build a large active pharmaceutical ingredient (API) manufacturing facility, on over 100 acres of land near Gwalior, Madhya Pradesh. Production capacity will be in line with Teva's large Indian competitors.Meanwhile, the remainder of the money will be used by Teva to fund the hopeful takeover of some Indian pharma businesses. The Israeli company's plans were revealed by Indian newspaper Business Standard, who reported that Teva has been eyeing major acquisition opportunities in India for the past three years, so far to no avail. Teva already has a presence in India through its Indian subsidiary, Teva India, in addition to a two year old R&D centre in New Delhi, however, a company spokesperson reportedly told Business Standard that: "Teva considers India an interesting geographical region and is looking to broaden its activities in the country".

link to full article

Nanotechnology Roadmap...Where's Pharm Bio???

Here a link to Guy Kawasaki's blog regarding a Nanotech Roadmap completed by the Batelle Memorial Institute...

Guy labels it "must-read"...I agree...I find this technological frontier fascinating...if only I could understand the material, (it was a struggle to get through the Executive Summary...)

I do have one or two questions...

Primarily, where's the Pharm Bio industry in all of this?... similar to the Human Genome, Nanotechnology appears to present great promise in the areas of health and life science...there just doesn't seem to be that much on these areas in the report...the participants tend to be from a variety of universites, or "labs" and "institutes", with not one pharma company on the list...the closest thing is an organization called the American Academy of Nanomedicine.

The table of contents list 39 individual articles produced by the Working groups which address specific issues...of this, 5 articles appear to deal with DNA, biology, life sciences, etc...(It is sometimes hard to tell just from the titles of the articles, and I am, quite frankly, not going to read the whole report). This hardly seems like this area is getting the focus it would appear to deserve (if all of the promise of the technology comes to pass) from the Pharm Bio side anyway...

I just haven't heard of any signifcant research efforts based on these ideas from any industry players...perhaps these efforts are underway, and I am just not aware of it...or maybe the Big Pharma companies are still stuck in the "chase the molecule" model? Perhaps this is an example of why drug pipelines are so dry...perhaps someone with more experience on the research side of the industry could provide a more current update of the current status of these efforts...

Secondly, could someone read the executive summary on this document and explain what it means to the Pharm Bio industry? Are we going to get our drug products from little desk-top factories? If so, how soon?, and will it cost less?

Maybe nanotechnology and future medicine will solve all our problems...only the future will tell, just ask Ray


some related links...

Guy's Blog- not to science oriented, he's a venture capitalist...

Batelle Memorial Institute

Foresight Institute

American Academy of Nanomedicine

Big Pharma Spends More On Advertising Than Research And Development,

If this turns out to be true, this is really painful...

A new study by two York University researchers estimates the U.S. pharmaceutical industry spends almost twice as much on promotion as it does on research and development, contrary to the industry’s claim.

link to full article

Looking Forward in 2008

Best Wishes (belated) for a Happy and Healthy New Year!!!

(back from a long holiday break, and looking forward to the new year...)

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.

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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.

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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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