Piling On to Avandia

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

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

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

Expert: Diabetes drug should be pulled

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

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

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

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

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

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

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

link to full article

10 Questions: Guy Kawasaki- Moira Gunn- Biotech

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

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

Tech Nation

FDA probing death in gene therapy trial

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

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

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

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

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

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

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

link to full article

FDA Regulations- the hits just keep coming...

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

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

FDA press release regarding regulation of nanotech issues...

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

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

enjoy...

My Recent Mail- Drug Safety Information

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

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

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

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

Drug Safety Issues

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

Pharma's love/hate relationship with Dr. Nissen

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

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

Governor files $1B biotech bill

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

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

link to full article

Biotech manufacturing jobs are desirable

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

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

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


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

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

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

link to full article

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

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

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

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

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

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

Life Sciences Greenhouse of Central Pennsylvania

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

like the Life Sciences Greenhouse of Central Pennsylvania

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



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

ISPE Singapore Student Chapter Blog

more from the other side of the world...

ISPE Singapore Student Chapter Blog

looking forward to seeing more from them...

ISPE and Bio Pharm Industry in India

Check out the India Affliate of the ISPE...over 50 new members in the past couple of months...

and they just had their big industry event...

ISPE India’s Annual Conference on Aseptic Manufacturing and Contamination Controls-Current Issues and Trends

Anybody out there have any news, infromation or feedback from this event to post???

Send me a link...

China Admits Executing Former Food Safety Chief

[Update]

Chinese Olympic Games assures safe food supply...oh, really...

How does this play out?

The toothpaste, the fish, the pet food...these are the ones we know about...

30 years ago, China was found to be the source of questionable product which caused multiple deaths...what's changed since then?

Unfornately, executing one person doesn't show the Chinese government is serious about reforming drug and food safety...I am afraid it proves exactly the opposite...China makes an example out of one poor soul, spins the media cycle with the "we need to improve..." headline backed up with the unspoken headline; "Look how serious we are, we killed the guy..."

We all nod and agree that it is a very serious issue...

And then they go back to business as usual...

I hope we aren't having this conversation 30 years from know...and more people don't have to lose their lives in order to get some progress on this painful issue.


China's drug watchdog has admitted food and drug safety supervision in the country is poor and in need of improvement. The comments came as China executed the former head of its food and drug administration for allowing unsafe drugs to enter the market in exchange for bribes.

China's food and drug administration spokeswoman, Yan Jiangying, acknowledged to reporters Tuesday China's food and drug safety was "unsatisfactory" and the country was facing a tough situation in supervising standards.

"As a developing country, China's food and drug supervision work began late and its foundations are weak," she said. "Therefore, the food and drug safety situation is not something we can be optimistic about."

Yan's comments came as the official Xinhua news agency reported the execution of the former head of the food and drug administration, Zheng Xiaoyu, after he was found guilty of corruption and dereliction of duty.

Zheng was sentenced to death in May for accepting cash and gifts worth more than $830,000 from pharmaceutical companies. Xinhua said his appeal was rejected because of the immense damage he had caused to public health and safety.

During his time as chief, the administration approved many medicines that did not meet standards, including six fake drugs. Zheng was the highest level official to be executed in seven years.

link to full article

Pioneering treatment for brain cancer gets Swiss approval

Now we're talking...

LONDON (AFP) - An experimental treatment for brain cancer has won approval for commercial use in Switzerland, its London-listed US maker, Northwest Biotherapeutics, Inc., announced on Monday.

DCVax-Brain will be available to patients in selected hospitals and medical centres in Switzerland before the end of September, the first time a treatment of this kind has been given market authorisation, it said in a statement.

"We are delighted to be the first company to reach the market with a personalized therapeutic vaccine for brain cancers, which carry a very bleak prognosis for patients," said Alton Boynton, president and chief executive of Northwest Biotherapeutics.

DCVax-Brain is designed to treat cancer by priming the patient's immune system to attack cancer cells.

The patient's own master immune cells, known as dendritic cells, are taken from the bloodstream while they are still at an immature stage.

These precursor cells are then matured in a lab dish while being exposed to biomarkers from the patient's own tumour, thus helping them to identify the cancer foe. Once they reach adult stage, the cells are injected back into the patient's body.

DCVax-Brain is currently in the second phase of the typical three-phase process of testing a new drug for safety and efficacy before it is licenced by the US Food and Drug Administration (FDA) and other medical watchdogs. It is being tested on 141 patients in the United States with glioblastoma multiforme, an especially aggressive form of cancer.

link to full article

Nanoparticles get a free ride

A breakthrough discovery in the US could see nanoparticles hitching a ride on red blood cells to become an ultimate drug delivery mechanism.

Nanoparticles have long been seen as a promising frontier for intravascular drug delivery but advances in the technology have been limited by the problem that nanoparticles are quickly removed from the blood rendering them ineffective in delivering drugs.

But researchers at the University of California, Santa Barbara, have found a solution to the problem - attaching nanoparticles to the surface of red blood cells (RBCs) dramatically increases the in vivo lifetime of the nanoparticles.

The research is published in the July 07 issue of Experimental Biology and Medicine.

"Attachment of polymeric nanoparticles to red blood cells combines the advantages of the long circulating lifetime of the red blood cell, and their abundance, with the robustness of polymeric nanoparticles," research team leader Dr Samir Mitragotri said is a statement.

link to full article

Fat Kills Cancer

Check out the last line of the second paragrpagh...I assume it was very "tongue-in-cheek"...

Turning Stem Cells Taken from Fat Tissue into Personalized, Cancer-Targeted Therapeutics

PHILADELPHIA - Researchers in Slovakia have been able to derive mesenchymal stem cells from human adipose, or fat, tissue and engineer them into "suicide genes" that seek out and destroy tumors like tiny homing missiles. This gene therapy approach is a novel way to attack small tumor metastases that evade current detection techniques and treatments, the researchers conclude in the July 1 issue of Cancer Research, a journal of the American Association for Cancer Research.

"These fat-derived stem cells could be exploited for personalized cell-based therapeutics," said the study's lead investigator, Cestmir Altaner, Ph.D., D.Sc., an associate professor in the Cancer Research Institute of the Slovak Academy of Sciences in Bratislava. "Nearly everyone has some fat tissue they can spare, and this tissue could be a source of cells for cancer treatment that can be adapted into specific vehicles for drug transport."

link to full article