'Designer baby' to be free from breast cancer

I don't know what to think about this...let the hype begin...

A British woman has made history by conceiving the country's first "designer baby" guaranteed to be free from hereditary breast cancer.

Using controversial screening techniques, doctors rejected six embryos which tested positive for the cancer gene in favour of "healthy" ones to ensure the child would not contract the disease.

The 27-year-old, who wishes to remain anonymous, is now 14 weeks pregnant with her first child after she was implanted with two of the cleared embryos.

She chose to go through the procedure because her husband had tested positive for the gene and his grandmother, mother, sister and cousin had all battled breast cancer.

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The Fierce 15 is out!!!

Just in case there isn't enough risk in earning your paycheck in the BioPharm industry...

and you want to actually invest money in these companies...

maybe even you own money...

FierceBio's Fierce 15 is out...

enjoy...

Sanofi launches $6.25bn vaccine battle plan

Wasn't it just a few years ago that no one was in the vaccine business because you couldn't make any money at it?

Sanofi-Aventis is to invest $6.25bn into vaccine production between now and 2015 as the company attempts to keep pace with rising demand.

This sizeable investment is in addition to the $940m the company has pumped into its French vaccine facilities between 2005 and 2008.

The company expects global vaccine sales to double to $34bn by 2016 and is investing heavily in construction or expansion at 15 sites to meet demand.

Speaking at the inauguration of its new $156m vaccine plant at Val de Reuil, France, Wayne Pisano, president and CEO of Sanofi-Aventis' vaccine subsidiary Sanofi Pasteur, said: "Sanofi Pasteur's commitment to global health is exemplified by significant investments in vaccine production infrastructures. These efforts are aimed at meeting a world demand for vaccines expected to double by 2016.

"The new facility will provide high-end production work environment for dedicated people who produce vaccines for the world."

Construction of the 7,800 sq. m. facility began in 2006 and is due to be operational by the end of 2008. Once online the plant will be capable of filling 200m vials and syringes a year, doubling the current capacity of Sanofi's operations at Val de Reuil.

link to full article

Microbix Chinese vaccine plant boosts global capacity by 20%

Now all we need to do is make a product without contaminations...

Canada-based Microbix has pulled off a coup in sealing a deal with the Chinese government for construction of a facility that will increase the world's vaccine supply by 20 per cent.

Construction of the $198m plant is to be jointly funded by Microbix and the Hunan provincial government, with the site due to become operational in 2013.

A more unusual aspect of the deal will see Microbix construct a replica of the childhood home of Dr Norman Bethune, a Canadian physician who is revered in China for his medical work assisting Chinese communists in resisting the Japanese in the late 1930s.

William Gastle, CEO of Microbix, said: "We've been working for a number of years to bring our technology to market, so today we're delighted to be partnering with the Province of Hunan in building and ultimately operating the most modern and efficient flu vaccine manufacturing facility on the planet.

"This will make China a leader in the production of flu vaccines, and Virusmax the technology of choice in helping other manufacturers in other countries expand their capacity to meet the needs of their populations."

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News from BIO 2008

BIOTECH: Artificial embryonic cells fuel research 'explosion'

BIO 2008 website

Drugmakers: Prepare for a Smackdown

The FDA plans to lay heavier regulations on Big Pharma.

For years the Food and Drug Administration has failed to adequately monitor the pharmaceutical industry. That conclusion by a special committee at the Institute of Medicine in a September 2006 report titled “The Future of Drug Safety” helped prompt a sweeping reform bill that became law last September. The Food and Drug Administration Amendments Act of 2007 gives the FDA the dollars and legal clout it needs to make a number of important fixes. Its key provisions and other new initiatives include these:

• The FDA will hire 1,300 new employees, with at least 400 dedicated to drug review.

• The agency has earmarked money for the development of a network of organizations to monitor the safety of FDA-approved drugs. Assembled and led by the FDA, the network participants—which include health-care insurers and providers—will have the ability to search millions of their own database records at the agency’s request. This surveillance system is built to identify problems, such as side effects of pharmaceuticals and medical therapies, as they emerge.

• All clinical trials of every FDA-approved drug must be registered on an NIH Web site, with results of those trials also posted.

link to full article

FDA might finally get its $275 mil

Job Fair at the FDA!!!...and you thought the life science job market was slow...

The FDA funding question has come full circle. First, the government's watchdog, the General Accounting Office, said FDA needed more money to do its job effectively. Then Congress asked FDA officials--repeatedly--to name a figure. A few months of that prodding finally yielded a number from Commissioner Andy von Eschenbach: $275 million.

Now, the Bush administration has seconded that figure, asking Congress to give FDA the money. HHS Secretary Michael Leavitt urged "Congress to act quickly to enhance the safety of food and medical products." With the added funds, FDA would open offices in China, India and Central America and hire another 490 people on top of the new employees it's already adding, bringing the total workforce expansion to 1,500, or 10 percent.

Apparently the big salmonella outbreak, linked to raw tomatoes, was the straw that broke the government's back. Coming on the heels of contaminated dog food, toothpaste, heparin, and more, the tainted tomatoes became one headline too many.

link to fiercepharm article

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FDA: 11 Deaths In Medical Devices Tied To Heparin

Unfortunately, we are now moving on to medical devices...

WASHINGTON -(Dow Jones)- The U.S. Food and Drug Administration has received reports of 11 deaths and other adverse events associated with medical devices that contain heparin, a widely used blood thinner that has sparked Congressional inquiries about the agency's oversight of drug manufacturing.

The FDA, in documents posted on its Web site Thursday, said it can't determine at this time whether the devices cited in the reports contain contaminated heparin.

Most of deaths were reported by families. As a result, FDA spokeswoman Karen Riley said, the agency in many cases can't identify the manufacturer or from which lots the heparin came. The FDA is working to contact the families to try to find more information.

Riley said the FDA was able to trace back two of the death reports to conclude that the heparin wasn't contaminated in those cases.

Contaminated heparin from China had previously been linked to 81 deaths in the U.S. and hundreds of allergic reactions. Baxter International Inc. (BAX) is the largest supplier of heparin.

link to full article

The View from the Outside

The extent to which the PharmBio market is perceived (by those outside this difficult and risky market)as "easy money" is very surprising...

An interesting post by Derek from In the Pipeline...

A Breath of Fresh Air from Fuji

Enjoy...

ISPE says quality programme starts to bear fruit

The International Society of Pharmaceutical Engineers has reported the first findings of a five-year new programme aimed at working tackling one of the toughest problems in pharma manufacturing at present - how to implement the new quality systems model laid out by the International Conference on Harmonization.

The first fruits of that programme, published in the June edition of the Journal of Pharmaceutical Innovation, represent a preliminary stage in attempting to provide practical guidance on how to implement these concepts into pharmaceutical processes.

Dubbed the Product Quality Lifecycle Implementation (PQLI), it was designed by ISPE as an initiative to help pharmaceutical manufacturers meet the requirements of ICH Q8, Q9 and Q10 in a way that would be acceptable to regulatory authorities.

link to full article