Greater Philadelphia Life Sciences Guide

more virtual neighbors...

lot's of good info here...

Greater Philadelphia Life Sciences Guide

FDA Considers Outsourcing 300 Jobs

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

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

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

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

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

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

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

link to full article

India had it going on!!!

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

PhRMA meet OPPI, OPPI meet PhRMA...

Big Pharma hits back at Indian patent laws

link to full article

Bird Flu Mutations

Study finds key markers for bird flu change

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

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

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

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

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

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

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


link to full article

Chinese Drug Quality

Recalling drug products missing the active ingredient!!!

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

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

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

link to full article

Big Pharma Blog...

Kudos to J+J and their corporate blog JNJ BTW

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

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

Evolution as a treatment?

Another interesting article by John Carrol at FierceBiotech...

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

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

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

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

New vaccine may beat bird flu before it starts

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

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

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

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

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

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

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

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

link to full article

More on India and Asia...

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

Asian countries push big pharma boom

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

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

Bio is harder to determine the real center...

but nothing stays the same but the changes...

Increasing Indian Influence...

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

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

Indian law on generic drugs is upheld

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

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

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

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

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

link to full article

Daily Pharma Updates from Fierce

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

and the sister publication... Fierce Biotech

East and West...

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

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

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

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

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

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

Piling On to Avandia

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

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

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

Expert: Diabetes drug should be pulled

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

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

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

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

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

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

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

link to full article

10 Questions: Guy Kawasaki- Moira Gunn- Biotech

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

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

Tech Nation

FDA probing death in gene therapy trial

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

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

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

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

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

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

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

link to full article

FDA Regulations- the hits just keep coming...

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

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

FDA press release regarding regulation of nanotech issues...

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

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

enjoy...

My Recent Mail- Drug Safety Information

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

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

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

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

Drug Safety Issues

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

Pharma's love/hate relationship with Dr. Nissen

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

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

Governor files $1B biotech bill

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

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

link to full article

Biotech manufacturing jobs are desirable

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

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

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


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

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

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

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