Wednesday, August 29, 2007

Greater Philadelphia Life Sciences Guide






more virtual neighbors...

lot's of good info here...

Greater Philadelphia Life Sciences Guide


Monday, August 27, 2007

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

Thursday, August 23, 2007

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

Wednesday, August 22, 2007

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


Monday, August 20, 2007

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


Monday, August 13, 2007

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...


Friday, August 10, 2007

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

Wednesday, August 08, 2007

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...

Tuesday, August 07, 2007

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

Monday, August 06, 2007

Daily Pharma Updates from Fierce

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

and the sister publication... Fierce Biotech

Wednesday, August 01, 2007

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...