Thursday, January 31, 2008

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

Wednesday, January 30, 2008

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

Tuesday, January 29, 2008

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

Monday, January 28, 2008

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

Friday, January 25, 2008

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 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

Wednesday, January 23, 2008

'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

Monday, January 21, 2008

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. 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

Thursday, January 17, 2008

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 “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

Wednesday, January 16, 2008

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 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

Monday, January 14, 2008

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

Friday, January 11, 2008

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

Thursday, January 10, 2008

Teva earmarks $1bn for India plans

Teva continues to set the 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

Tuesday, January 08, 2008

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

Sunday, January 06, 2008

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...)