Monday, October 31, 2005

Roche seeking partners to increase Tamiflu production

Update from previous story regarding tamiflu

SHANGHAI (AFX) - Swiss drug maker Roche is in talks with companies to set up a global manufacturing network to increase capacity to produce the anti-bird-flu drug Tamiflu as soon as possible, the Shanghai Daily reported, citing a company executive.

Roche, which owns the manufacturing rights for Tamiflu, has received more than 100 requests from companies seeking licenses to make the drug, Jan Van Koeveringe, head of Roche global technical operations told the paper.

'The next thing we will do is send out inquiries to get the details of what capacity is available so we then have as soon as possible a global manufacturing network for the supply of Tamiflu,' the paper cited him as saying.

He said that an applicant company has to be able to 'add substantial capacity' to Roche's global supply chain before collaboration can occur. He did not give figures.

Roche has been under pressure to increase output of Tamiflu, as thousands of migratory birds moving across international borders carry with them the risk of spreading avian flu, the paper said. Growing fears of a bird-flu pandemic have caused global demand for the drug to soar.

Global health experts fear the virus could mutate and spread among humans, causing a worldwide epidemic. The H5N1 strain of bird flu has killed at least 63 people in Southeast Asia since 2003, the majority of them in Vietnam, the paper noted.


Friday, October 28, 2005

'Start of life' gene discovered

"Harnessing the Human Genome will make harnessing the atom look like childs play..."

I don't know who said that, or made a vaguely similar statement, but I believe it to be true.

I am continually amazed at what is being discovered in this area. I guess we are all waiting for more real-world results instead of pure research...

Scientists have found the gene responsible for controlling a first key step in the creation of new life.
The HIRA gene is involved in the events necessary for the fertilisation that take place once a sperm enters an egg.

Faults in this gene might explain why some couples struggle to get pregnant despite having healthy sperm, say the researchers from the UK and France.

link to full article on

Wednesday, October 26, 2005

Flipped Genetic Sequences Illuminate Human Evolution And Disease

Maybe we should tech this in religion class...

y comparing the human genome with that of the chimpanzee, man's closest living relative, researchers have discovered that chunks of similar DNA that have been flipped in orientation and reinserted into chromosomes are hundreds of times more common in primates than previously thought. These large structural changes in the genome, called inversions, may account for much of the evolutionary difference between the two species. They may also shed light on genetic changes that lead to human diseases. Although humans and chimpanzees diverged from one another genetically about six million years ago, the DNA sequences of the two species are approximately 98 percent identical. Given the 2005 publication of the draft chimpanzee genome sequence, researchers can now readily identify the differences between the human and chimp genomes. These differences lend insight into how primates evolved, including traits specific to humans. The researchers published their findings in the October 28, 2005, issue of the journal Public Library of Science Genetics (PLoS Genetics). The paper was published early online. Senior author Stephen W. Scherer is a HHMI international research scholar, a senior scientist in the Genetics and Genomic Biology Program at the Hospital for Sick Children in Toronto, Canada, and an associate professor of molecular and medical genetics at the University of Toronto.

Monday, October 24, 2005

Stanford University Sees Biotech Campus

Everybody's doing it!!!

Stanford University has bought 29 acres and nearly 550,000 square feet of older office/R&D property in Redwood City with the hope that the site will become a new biotech hub with links to Stanford faculty, researchers and students. Stanford did not release details of the purchase of the site, once part of the Excite @ Home campus, from a partnership that includes San Francisco's TMG Partners. The sale price was also omitted from documents on file with the San Mateo County recorder's office. It is the largest off-site acquisition of real estate by the university, perhaps ever, according to the school's vice provost, and follows Stanford Hospital and Clinics' decision earlier this year to buy four neighboring buildings for outpatient medical care. That project, now awaiting Redwood City review, greatly colored the university's decision to buy the second tract, school executives say, because it opened possibilities for life-science-related commerce that would not otherwise have materialized.


Friday, October 21, 2005

Chiron misses flu vaccine production target again

18/10/2005 - Chiron has warned it will yet again fall short of targets for its US flu vaccine deliveries this year due to continuing production problems with its British manufacturing plant.

Speaking on a conference call on Monday, Chiron's chief executive Howard Pien said the plant would produce fewer than 18 million doses of flu vaccine for the 2005–06 flu season, down from a previous estimate of between 18 and 26 million doses.
In an average year in the US, influenza causes more than 200,000 hospitalisations and kills approximately 36,000 people, primarily in the over-65 population.

Influenza vaccination is the most effective way to prevent influenza.

link to full article from in-pharmatech

Wednesday, October 19, 2005

S.Korea launches ambitious global stem-cell project

SEOUL (Reuters) - South Korea launched on Wednesday a an ambitious project to make the country a global hub for stem-cell storage and research, hoping to further cement its status at the forefront of cloning research.

Helped by generous government support and an absence of some of the red-tape and ethical debate that has hampered research in countries such as the United States, South Korea is fast becoming a key center for stem-cell research.

Stem cells are master cells in the body that can develop into any cell type. Scientists are trying to learn how to manipulate them for transplants to treat diseases such as Alzheimer's or diabetes.

link to full article

Tuesday, October 18, 2005

Cipla bird flu drug defies Roche

17/10/2005 - Cipla announced plans on Friday that will see it become the first company to sell a generic version of the anti-influenza drug Tamiflu.

The company claimed it was already making generic Tamiflu (oseltamivir phosphate) and should have its first batch of 1,300 treatments on the market in early 2006.
Tamiflu, which reduces the severity and spread of traditional flu, is already in short supply throughout the world, as countries gather stockpiles of the drug amid fears of a possible avian flu epidemic.

link to full article from in-pharmatech

Roche considers flu drug partners

Drug firm Roche may allow other companies to produce its antiviral drug Tamiflu under licence to help combat a potential flu pandemic.
The Swiss firm is considering ways of boosting output of Tamiflu, the main treatment for the deadly strain of bird flu which struck Asia last year.

Roche is now producing Tamiflu at 13 sites worldwide and has received orders for the drug from 40 countries.

The World Health Organization advised countries to stockpile supplies.

link to full article from

More doubt on blood pressure drug

A large study has provided fresh evidence that a drug widely used to treat high blood pressure may not be the best option for many patients.
A Swedish team analysed data on more than 105,000 people and found beta blockers were not as effective as other drugs in reducing high blood pressure.

The Lancet findings echo a high profile international study last month which found modern drugs were more effective.

Beta blockers are used to treat more than two million UK

link to full story on

Monday, October 17, 2005

Prof develops cancer nanobomb

Great Stuff!!! treating cancer with nanotechnology!!!

3:38 p.m., Oct. 13, 2005--University of Delaware researchers are opening a new front in the war on cancer, bringing to bear new nanotechnologies for cancer detection and treatment and introducing a unique nanobomb that can literally blow up breast cancer tumors.

Balaji Panchapakesan, assistant professor of electrical and computer engineering at UD, has recently reported on the discoveries in the journals NanoBiotechnology and Oncology Issues.

He is the lead investigator for a team that includes Eric Wickstrom, professor of biochemistry and molecular biology at Thomas Jefferson University in Philadelphia and his student Greg Cesarone, and UD graduate students Shaoxin Lu, Kousik Sivakumar and postdoctoral researcher Kasif Teker.

link to full article

Friday, October 14, 2005

Calif. court taking up motion to toss stem cell bonds

and bouncing...

SAN FRANCISCO (Reuters) - A California judge overseeing a lawsuit to prevent the state from issuing up to $3 billion in bonds for its stem cell research institute has scheduled a hearing on November 17 on a motion to dismiss the lawsuit, a spokesman for the state's lawyer said on Thursday.

The motion by California Attorney General Bill Lockyer aims to free the state to issue the voter-approved general obligation bonds, which could total $3 billion over 10 years, said Lockyer spokesman Nathan Barankin.

The debt would fund studies into using human stem cells for therapies or cures to various illnesses and ailments, an initiative backed by Republican Gov. Arnold Schwarzenegger.

His support for the work, which may include using stem cells from human embryos, is at odds with U.S. President George W. Bush's restrictive approach to the research.

Legal challenges to the debt sales for the California Institute for Regenerative Medicine have "effectively prevented the state from marketing the bonds," according to Lockyer's motion filed in Alameda County Superior Court.

link to full article

Mo. Groups Propose Stem Cell Amendment

The stem-cell issue keeps bouncing...

JEFFERSON CITY, Mo. - A coalition of researchers and patients groups proposed a constitutional amendment Tuesday to protect stem cell research in Missouri, where anti-abortion activists have tried to outlaw a particular type of research they say amounts to the taking of a human life.

Supporters of the amendment must gather at least 139,181 petition signatures from voters to get the measure on the November 2006 ballot. Anti-abortion groups want to "criminalize some of the most promising types of stem cell research," coalition chairman Donn Rubin said.

The coalition claimed its proposal was the first in the nation to protect patients' rights to be treated with any eventual stem cell-related cures. It would specify that stem cell research, therapies and cures allowed under federal law also are permitted in Missouri.

link to full article

Thursday, October 13, 2005

Wyeth phases out NY facility

12/10/2005 - Pharmaceutical manufacturers, Wyeth, are to phase out manufacturing at its US facility as part of its consolidation plans, which will see the gradual phasing out of all operations at the New York facility by late 2008.

The three-year transition plan aims to phase out production of over-the-counter drugs as well as some of the best-selling ethical drugs currently on the market. The facility, located at Rouses Point, New York, manufactures and packages all dosage forms, from solid dosage to sterile fills.

pharmatech link to full story

Wednesday, October 12, 2005

Monday, October 10, 2005

FDA Adviser Resigns Over Plan B Handling

WASHINGTON - A consultant to a Food and Drug Administration advisory panel has resigned in protest of the agency's handling of the Plan B contraceptive.

Dr. Frank Davidoff, editor emeritus of the Annals of Internal Medicine, said the agency is ignoring science in favor of politics in delaying approval of the drug for over-the-counter sales.

He was a member of the FDA's Nonprescription Drugs Advisory Committee when it voted to approve Plan B for over-the-counter sales in 2003, and had served as a consultant to the committee since his term ended earlier this year.

Davidoff is the second person to publicly resign over Plan B. In late August, the top women's health official at FDA, Susan Wood, also resigned in protest. Former FDA Commissioner Lester Crawford has also since resigned.

Plan B, which can be used as emergency, morning-after contraception, is opposed by some religious conservatives.

The committee Davidoff was on is one of several scientific advisory committees that provide the FDA with an independent assessment of new drugs.

link to full story

Tuesday, October 04, 2005

Continuous Education- Part 3

and don't forget Interphex...

March 21-23
Jacob Javits Convention Center
New York, NY

and in case you have an extra presentation lying around that you have been dying to present...they're looking for speakers

SpeakerService: Interphex 2006

Continuous Education- Part 2

I'll be going to the ISPE meeting...see you there...

Celebrate 25 Years of Excellence!

Join your colleagues from around the world
for the pharmaceutical manufacturing industry's
number one educational event.

6-10 November 2005
Scotsdale, Arizona

ISPE 2005 Annual Meeting

Continuous Education- Part 1

got the following via snail mail, as the expression goes...

"In-Depth GMPs for Pharma and Biotech"

December 7-9 Las Vegas, Nevada for more info

Monday, October 03, 2005

New Lifespan Extension Genes Found

New genes tied to lifespan extension in yeast have been identified by researchers from UC Davis and Harvard Medical School.

Drastically reducing calorie intake, or caloric restriction, is known to extend the lifespan of species including yeast, worms and rodents. Previous research linked a gene called Sir2 with lifespan extension due to caloric restriction, but worms and yeast that lack Sir2 also live longer when put on a tough diet, showing that some other genes must be at work.

Researchers led by David Sinclair at Harvard Medical School and Su-Ju Lin at UC Davis' Center for Genetics and Development and Section of Microbiology screened for other life-extending genes in yeast. They found a gene called Hst2 that accounts for most of the difference.

link from