Sanofi breaks ground in cell culture-based vaccine production

28/09/2006 - With the first clinical trial of its cell culture-based seasonal influenza vaccine commencing in the US, Sanofi Pasteur has demonstrated the production scale potential of a cell line in a successful bioreactor run of 20,000L.

link to full article

Takeda Pharmaceutical Co. To Use $8.6 Billion On Drug Development

somebody else to do business with...

TOKYO, Sept 22 (Reuters) - Takeda Pharmaceutical Co., Japan's biggest drug maker, plans to spend more than 1 trillion yen ($8.6 billion) to develop new drugs over five years through 2010/11, the Yomiuri Shimbun daily reported on Friday.

Researchers get $100m to study cancer genetics

Somebody to do some business with...

A New York philanthropy is giving $100 million to the Broad Institute of the Massachusetts Institute of Technology and Harvard and four New York research centers to study the genetics of cancer, part of the push to transform the treatment of the disease by understanding its genetic makeup.

``There is just an extraordinary opportunity in cancer research right now," said Eric Lander, director of the Broad Institute, during a press conference yesterday announcing the award. ``The clinical and biological insights of the last decade and a half have really pointed us to where the problems are."

Executives at The Starr Foundation, established in 1955 by businessman Cornelius Vander Starr, said their only restriction for the money is that the five entities collaborate on projects, because they believe that scientists will find cures faster than if they work only with colleagues at their own institutions.

The other members of the consortium are Cold Spring Harbor Laboratory, Memorial Sloan-Kettering Cancer Center, The Rockefeller University, and Weill Medical College of Cornell University.

link to full article

Wal-Mart Stores offers $4 generic drugs in Florida

TAMPA, Florida (Reuters) - Wal-Mart Stores Inc., the world's largest retailer, said on Thursday it would cut the prices of nearly 300 generic drugs to $4 per prescription starting in the retirement haven of Tampa, Florida.

The move, immediately copied by rival Target Inc., slammed stock prices of drug retailers, with shares of No. 2 U.S. drugstore chain CVS falling 8.4 percent.

Wal-Mart characterized the program as "part of its ongoing commitment to provide affordable health care to America's working families," but critics called it a public relations move by a giant retailer accused of gobbling up mom-and-pop stores, relentlessly pressuring competitors and suppliers with discounted prices and refusing to provide insurance for many employees, forcing them to rely on government health plans.

Still, some consumer advocates said the move might drive down drug prices in general, and shares of generic drugmakers also fell.

link to full article

Roche hikes US Tamiflu production capacity

18/09/2006 - Roche has boosted annual manufacturing capacity for Tamiflu (oseltamivir phosphate) to 80m treatment courses, as demand for the flu drug shows no sign of abating.

The rise means Roche's global production network will be capable of producing 400m courses of Tamiflu annually by the end of 2006, a more than ten-fold increase since 2004.
The Swiss drug firm has predicted sales this year for Tamiflu will reach SFr1.1bn to SFr1.2bn (€7bn-€7.5bn), excluding sales as a treatment for regular influenza.

Amidst fears of a bird flu pandemic, the US Department of Health & Human Services (HHS) has been adamant that the US should be self-reliant in the supply of Tamiflu, so Roche and its external contractors have established all aspects of Tamiflu production in America, from synthesis of the initial starting material through all major steps of manufacturing to finished packs.

link to full article

FDA Statement on Foodborne E. coli O157:H7 Outbreak in Spinach

The U.S. Food and Drug Administration (FDA) will continue to provide the public with regular updates on the E. coli O157:H7 outbreak each day until further notice.

Case Reports
To date, 114 cases of illness due to E. coli infection have been reported to the Centers for Disease Control and Prevention (CDC), including 18 cases of Hemolytic Uremic Syndrome (HUS), 60 hospitalizations, and one death. Illnesses continue to be reported to CDC. This is considered to be an ongoing investigation.

States Affected
There are now 21 confirmed states: California, Connecticut, Idaho, Illinois, Indiana, Kentucky, Maine, Michigan, Minnesota, Nebraska, Nevada, New Mexico, New York, Ohio, Oregon, Pennsylvania, Utah, Virginia, Washington, Wisconsin, and Wyoming.

Consumer Advice
FDA advises consumers not to eat fresh spinach or fresh spinach-containing products until further notice.

link to full statement

related story...

Restaurant chains pull spinach from menus

Biotech Locations and the Job-creating Machine...

I have been noticing lately certain states are working to postion themselves in the life sciences markets...I believe this is because they see the biosciences as a new economic engine for creating jobs, etc...

see some recent posts regarding:

Maryland, California, and Indiana to name a few...

I had thought of getting these all together in a posting with a brief discussion of who, what, and where...

turns out, fiercebiotech.com has already taken a shot at this with an article titled "Top Five Regions Targeting Biotech Companies", enjoy...

other links regarding other locations to be posted shortly...

Gates Foundation gives $68 million to fight tropical diseases

SEATTLE -- The Bill & Melinda Gates Foundation announced Thursday four grants totaling more than $68.2 million to fight three tropical diseases that affect hundreds of millions of people each year in Africa, Asia and Latin America.

The diseases - hookworm, leishmaniasis and trypanosomiasis - are transmitted by parasites and worms. They can cause death or lifelong disfigurement or stunt children's growth and mental development.

No vaccines exist to prevent most of these diseases and the few drugs that are available to combat them are expensive and have serious side effects, foundation officials said.

"Many of the world's most debilitating illnesses are virtually unheard of in the rich world. But they're a fact of life for millions of people in poor countries," said Tachi Yamada, president of the global health program at the Gates Foundation.

The largest of the four grants will give $32 million to the Seattle-based Infectious Disease Research Institute to speed up development of a vaccine for leishmaniasis. This parasitic disease affects more than 12 million people worldwide and kills thousands each year, the World Health Organization said.

link to full article

gates foundation

More Pfizer plants axed as restructuring continues

15/09/2006 - Pfizer’s manufacturing reforms have claimed more casualties in two North American plants as the world’s largest drugmaker battles to realign production capacity with future product mix, new technologies and cost effectiveness.

The two sites in Arnprior, Ontario, and Lee's Summit, Missouri, have been dropped as part of Pfizer's multi-year review of all manufacturing operations that began in 2003 following the acquisition of Pharmacia.
After its merger with Warner Lambert in 2000, Pfizer acquired Pharmacia for $60bn (€47.1bn) in 2003 and has been trying to sort out its manufacturing network ever since.

Over the past three years Pfizer has announced plans to divest or close more than two dozen plants globally, reducing the number of its manufacturing facilities from 93 to 64.

“The company needs to transform its global manufacturing capabilities to match the type of new products emerging from our pipeline and overall product demand,” Pfizer spokeswoman Judy Sandlin Brooks told In-PharmaTechnologist.com.

“So there is an underlying trend, we are implementing a global initiative to adjust our production capacity.”

The Arnprior site manufactures and packages various prescription and over-the-counter products in tablet or capsule form, including Norvasc, Viagra, Reactine and Visine, but Pfizer says it can make these products now cheaper elsewhere and wants sites that can also make inhalable and injectable drugs.

link to full article

Alcohol use helps boost income: study

What? maybe little off topic, but we're all interested in what affects our income...

WASHINGTON (AFP) - People who consume alcohol earn significantly more at their jobs than non-drinkers, according to a US study that highlighted "social capital" gained from drinking.

The study published in the Journal of Labor Research Thursday concluded that drinkers earn 10 to 14 percent more than teetotalers, and that men who drink socially bring home an additional seven percent in pay.

"Social drinking builds social capital," said Edward Stringham, an economics professor at San Jose State University and co-author of the study with fellow researcher Bethany Peters.

"Social drinkers are out networking, building relationships, and adding contacts to their BlackBerries that result in bigger paychecks."

The authors acknowledged their study, funded by the Reason Foundation, a libertarian think tank, contradicted research released in 2000 by the Harvard School of Public Health.

"We created our hypothesis through casual observation and examination of scholarly accounts," the authors said.

"Drinkers typically tend to be more social than abstainers."

The researchers said their empirical survey backed up the theory, and said the most likely explanation is that drinkers have a wider range of social contacts that help provide better job and business opportunities.

link to full article

GSK opens vaccine plant in Hungary

07/09/2006 - GlaxoSmithKline (GSK), a major player in vaccine manufacturing, is set to inaugurate a €100m vaccine production plant on Friday in a Hungarian city 30Km northeast of Budapest.

According to a GSK spokesman, the new site in Godollo will be one of Europe's most advanced biotechnology plants and will manufacture two types of vaccines, though more details were not disclosed.
The company employs around 360 people in Hungary and had turnover of €106.8m in 2005.

GSK earlier said it plans to manufacture DPT, a combination of three vaccines to immunise against diphtheria, pertussis and tetanus, at the Godollo plant.

The drugmaker plans output in the order of 100m units a year to cover its entire world-wide needs.

link to full article

Red Cross Fined $4.2 Million Over Blood Safety

Uh-oh...

WASHINGTON (Reuters) - The U.S. government fined the American Red Cross $4.2 million for failing to ask blood donors proper screening questions and skipping other steps meant to keep the blood supply safe, officials said on Friday.

The fine, the largest ever levied by the Food and Drug Administration for a blood safety violation, follows a multiyear battle between the FDA and the Red Cross, which collects about 45 percent of the blood donated in the United States each year for transfusions.

The agency said it had no evidence that any blood collected by the Red Cross harmed people who got transfusions.


But FDA officials said the failure to follow multiple safeguards increased the risk that patients could receive blood tainted by an infectious disease.

"It is not acceptable that the quality systems failed in this way," Margaret O'K. Glavin, FDA associate commissioner for regulatory affairs, told reporters.

link to full article

Senators Denounce Scientist's Stem Cell Claims

The political football stem cell research takes another bounce...

Confusion Over Harm to Embryos In Study at Issue

By Rick Weiss
Washington Post Staff Writer
Thursday, September 7, 2006; Page A04

Two senators who strongly support human embryonic stem cell research lashed out yesterday at the scientist who recently reported the creation of those cells by a method that does not require the destruction of embryos, saying the scientist and his company have harmed the struggling field by overstating their results.

"It's a big black eye if scientists are making false and inaccurate representations," a combative Sen. Arlen Specter (R-Pa.) said during a hearing of the Senate Appropriations labor, health and human services subcommittee, which he chairs.

Sen. Arlen Specter: "It's a big black eye if scientists are making false and inaccurate representations."

Robert Lanza of Advanced Cell Technology (ACT) in Worcester, Mass., defended his work and the company's statements. "Our paper is 100 percent correct," said the visibly shaken scientist, referring to the highly publicized article that appeared in the Aug. 24 issue of the journal Nature.

link to full article

ISPE Blog at the Annual Meeting

I just got an e-mail today from Marsha Strickhouser who is the Public Relations Manager for ISPE...

The Annual Meeting will be having a dedicated blog this time around...

I'm really looking forward to this and I hope everybody gets involved with this...it should be a lot of fun...

Look for links and posts to be coming soon...

ISPE Annual Meeting
05-08Nov06
Orlando, FL

Maryland mulls 'vaccine manufacturing capital of the world' dream

some states really see the biosciences as an economic engine...It would be interesting to gather all this together into one package...


31/08/2006 - Bruised by Novartis’s snub over a $600m (€466m) vaccine plant, Maryland has commissioned a study on what more the state can do to attract a major cell culture vaccine manufacturing facility there.

Although the study has not yet been released, In-PharmaTechnologist.com has learned that in its findings the report suggests that the city of Baltimore and the state of Maryland will need to work much harder to attract biotech investment given the financial incentives that other states provide.
The state had been in the running with North Carolina and Georgia for Novartis's plant, which will be the first facility in the US to use novel cell culture technology, but Aris Melissaratos, Maryland's secretary of the Department of Business and Economic Development, said that other states were willing to give away free land and so Maryland couldn't compete with that sweetener given this region's high real estate prices.

Nevertheless, the state still has several firms that have committed to building manufacturing plants there, such as MedImmune and Emergent BioSolutions, yet the selection of North Carolina by Novartis stroke a raw nerve among those who have higher aspirations for Maryland.

“Maryland is doing exactly what it can and should be doing to attract more biotech firms and the vaccine feasibility study is a prime example,” Morgan Wallace, of the Economic Alliance of Greater Baltimore, the organisation behind the report, told In-PharmaTechnologist.com.

link to full article from in-pharma tech

'Virtually untreatable' TB found

Now here's the really scary story...


About 1.7 million people die from TB globally each year
A "virtually untreatable" form of TB has emerged, according to the World Health Organization (WHO).
Extreme drug resistant TB (XDR TB) has been seen worldwide, including in the US, Eastern Europe and Africa, although Western Europe has had no cases.

Dr Paul Nunn, from the WHO, said a failure to correctly implement treatment strategies was to blame.

TB experts have convened in Johannesburg, South Africa, to discuss how to address the problem.

TB presently causes about 1.7 million deaths a year worldwide, but researchers are worried about the emergence of strains that are resistant to drugs.

link to full article

Companies help schools produce bio-hires

Some states really do see the biosciences as an economic engine...

Biotech companies think globally about product development and marketing. But for their workforces, they need to hire locally.

What began in 2002 as a partnership between industry, government and local community colleges to retrain displaced Bay Area airline workers following Sept. 11 has turned into an award-winning, widely copied job-training program to build biotechnology's employment pipeline.

Skyline College in San Bruno was one of the first to begin working with Genentech to train workers specifically for entry-level biomanufacturing jobs.

Since its program began in 2002, 160 students have enrolled in the 12-week certificate program. Of 153 who completed it, 135 have taken full-time jobs and 20 are working toward their certificates. The average starting wage for certificate holders is $18.89 an hour.

Students who've completed a certificate program hold support positions like bioprocess technician, which involves preparing media and solutions for bioprocesses and reviewing documentation and calculations. Genentech would not say what percentage of its workforce holds such entry-level, biomanufacturing positions, but said this year it expects to increase its headcount by 15 percent company-wide. The 1,500 new employees will work in all departments at all levels.

Skyline's certificate program was created in close collaboration with Genentech to help the biotech giant meet its growing need for entry-level workers. Monica Poindexter, Genentech's associate director for corporate diversity and college programs, called the program "extremely successful."

Others in the industry have noticed. William Watson, director of the center for Workforce Development at Skyline, said that more than 25 local companies, from Applied Biosystems to Bayer to Chiron (now part of Novartis), now employ Skyline certificate holders.

link to full article

ICH Q8 & Q9- ISPE/ PDA Seminar

I always wondered when PDA was going to get together with ISPE

Challenges of Implementing ICH Q8 & Q9- Practical Applications

December 6-7
Washington DC
USA