Drug Makers, FDA Partner on Drug Safety

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

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

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

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

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

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Mercury-Containing Vaccine Vindicated

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

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

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

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

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

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

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

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Wal-Mart Expands $4 Drugs Program

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

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

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

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

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

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Industry events in India- Interphex

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

ISPE and Bio Pharm Industry in India

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

but check out Interphex India

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

Innovation 'key' to India's pharma future

Phoenix vision for new biotech campus poised to expand

More job creation investments...

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

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

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

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

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

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Genzyme to begin $150m expansion of Allston plant

Northeast job creation!!!

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

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

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

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

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

Nanotech is promising, but faces hurdles

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

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

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

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

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

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

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

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

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

The groundbreaking work is published in Nature.

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

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

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

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

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

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

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Stem cells show potential to repair lungs

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

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

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

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Massive counterfeit drug ring cracked

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

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

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

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

link to full story

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

Why isn't this on Youtube?...

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

link to full story

link to video

China recalls leukaemia drugs in safety scare

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

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

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

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

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

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

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

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

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

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

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

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Betting on Nanotech Therapies

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

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

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

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

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Lab pipe caused foot-and-mouth outbreak

Tree roots???!!!...

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

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

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

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

The Environment Department would not comment on the report Wednesday.

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

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

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

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


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China persists with pharma reforms

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

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

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

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

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

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

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

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

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Humans' DNA Not Quite So Similar

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

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

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

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

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

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