Thursday, November 29, 2007
Wednesday, November 28, 2007
A suggestion for a new SOP...
all process equipment should be cleaned at least every 5 years, or so...
The tank, in fact, was not cleaned at all between 2001 and the end of the company's April 2006 production run.
Following non-routine maintenance, the holding tank was then cleaned using ethanol according to SOP guidelines. Crucially, however, the tank was not dried afterwards to rid it of any residual ethanol.
The tank therefore still contained the alcohol when it was charged with the starting material, MSA. This resulted in a reaction that caused high levels of EMS in the Viracept starting material.
The official report into good manufacturing practice (GMP) failures that caused dangerous contamination and a Europe-wide recall of Roche's HIV drug Viracept (nelfinavir) claims the firm simply did not understand its own manufacturing processes.
The Committee for Medicinal Products for Human Use (CHMP) published its assessment yesterday, recounting the inspections and discussions that took place in the wake of the June recall and noting the "critical GMP deficiencies" that resulted in the suspension of Roche's Viracept marketing authorisation.
The European Medicines Agency (EMEA) carried out an inspection of Roche's active ingredient manufacturing facility in Basel in collaboration with Swiss regulators Swissmedic, to assess conditions at the plant where the contamination occurred.
Their examination revealed violations that not only led to the high-level contamination reported over the summer, but also led to questions regarding regular manufacturing processes and concerns over "the quality of Viracept and its safety under normal conditions of use."
link to full article
Tuesday, November 20, 2007
Follow-up to the story below and others...
NEW YORK - Scientists have made ordinary human skin cells take on the chameleon-like powers of embryonic stem cells, a startling breakthrough that might someday deliver the medical payoffs of embryo cloning without the controversy.
Laboratory teams on two continents report success in a pair of landmark papers released Tuesday. It's a neck-and-neck finish to a race that made headlines five months ago, when scientists announced that the feat had been accomplished in mice.
The "direct reprogramming" technique avoids the swarm of ethical, political and practical obstacles that have stymied attempts to produce human stem cells by cloning embryos.
Scientists familiar with the work said scientific questions remain and that it's still important to pursue the cloning strategy, but that the new work is a major coup.
"This work represents a tremendous scientific milestone — the biological equivalent of the Wright Brothers' first airplane," said Dr. Robert Lanza, chief science officer of Advanced Cell Technology, which has been trying to extract stem cells from cloned human embryos.
"It's a bit like learning how to turn lead into gold," said Lanza, while cautioning that the work
link to full article
Monday, November 19, 2007
I couldn't decide to go with a "the more things change, the more they stay the same" or a joke about "evolution"...
LONDON - The Scottish scientist who created Dolly the sheep more than a decade ago said he is abandoning the cloning technique that he pioneered, according to an interview published Saturday.
Ian Wilmut, who led the team that created Dolly in 1996, told The Daily Telegraph that he is abandoning cloning to pursue a new technique that can create stem cells without an embryo.
Wilmut's announcement could mark the end of therapeutic cloning, in which DNA is inserted into an unfertilized egg, an embryo is produced and stem cells are harvested, the newspaper said. Tens of millions of dollars have been spent worldwide on therapeutic cloning research in the past decade, but nobody has made it work in humans.
Wilmut believes a rival method pioneered in Japan that creates stem cells from fragments of skin is better for growing tissue that can be used to treat people who are paralyzed or have illnesses ranging from diabetes to Parkinson's disease.
He said the Japanese method does not require human eggs, making it "easier to accept socially" than his Dolly method, known as "nuclear transfer." The Japanese method removes the need to destroy embryos - an action many people oppose and that has become a major stumbling block for funding and regulating research.
"I decided a few weeks ago not to pursue nuclear transfer," Wilmut was quoted as saying.
link to full article
Thursday, November 15, 2007
I have always wondered how they got people to volunteer for this type of study...
because of this exact issue...
WASHINGTON (Reuters) - Thousands of people who volunteered to test an experimental AIDS vaccine that may have actually raised the risk of infection will be told if they got the actual shot, researchers said on Tuesday.
Merck & Co. Inc. and academic researchers said they would "unblind" the study, meaning everyone would find out who got the active shot and who got a dummy injection.
Two international trials of the experimental vaccine were stopped in September after it became clear the vaccine did not prevent infection with the AIDS virus.
The trials were conducted in the United States, Peru, Brazil, Dominican Republic, Haiti, Jamaica, Australia and South Africa.
Earlier this month, researchers said they saw some worrying indications that the vaccine somehow raised the risk of infection, although they stressed the vaccine could not itself cause HIV infection.
link to full article
Monday, November 12, 2007
to job creation...that is...
unlike New Jersey, other states are investing...
Alabama...$65 million biotech wing opens
or private investment to complement public spending...Pfizer's Biotech Center
I'm sure there are others...
Thursday, November 08, 2007
TRENTON, Nov. 6 — In a stunning defeat for Gov. Jon S. Corzine, New Jersey voters on Tuesday rejected a ballot measure that would have permitted the state to borrow $450 million for stem cell research.
The sound defeat, coupled with the failure of another initiative that would have set aside more money for property tax rebates, marked the first time in 17 years that voters in New Jersey had defeated any statewide ballot question.
The ballot questions offered a rare surprise on a day in which Democrats maintained their control over both houses in the State Legislature. As of midnight, Democrats appeared poised to add one seat to their 22-18 majority in the Senate by winning seats in Atlantic City and Cape May Counties that had been in the hands of Republicans. In the Assembly, Republicans appeared to chip one or two seats from the Democrats’ current 50-30 majority.
But it was the defeat of the stem cell measure by a resounding 53-47 percent margin that dealt a sharp blow to Mr. Corzine, who had campaigned heavily for it and had contributed $150,000 to the effort.
Supporters had argued that the borrowing would help pay for research that could help deliver New Jersey from financial distress by bringing additional tax revenue and tens of thousands of jobs to the state. Critics, by contrast, said that New Jersey could not afford to add to the state’s surging debt load of $30 billion.
link to full article
Tuesday, November 06, 2007
and China weighs in on the biotech front...
An executive report on the emerging companies, government incentives and recent investments that are defining China's burgeoning biotech industry. Plus, access to China Biotechnology database!
China Biotech 2008, a new report written by General Biologic and published by BioWorld Today, provides an unprecedented look at biotechnology activities in China. This report provides an in-depth review of the biotech industry mix (service provider, innovators and biogenerics companies), provides an analysis of the Chinese government's role in biotech, and investigates the fundamentals of success and failures present within the commercial enterprise sector.
Hundreds of new biotech companies have recently emerged in China, and several have even listed shares on the U.S. capital markets – a bold sign of things to come. Indeed, biotechnology services, innovation and generics have thrived despite a number of significant obstacles. This report reviews these obstacles and illustrates the tenacity of China's companies to succeed. We review how these different areas in China are being shaped by different forces and how each one will play an important role on the global biotech stage.
link to report page
Monday, November 05, 2007
Who has any reason to be doing this?...
Self-medication a concern; FDA-approved generics may be cheaper alternative
A yearlong U.S. Food and Drug Administration (FDA) investigation into drugs mailed to the United States from foreign countries suggests that consumers may be buying drugs online to avoid the need for a prescription from their physician. The FDA sampling of imported drugs also indicates that consumers continue to spend money unnecessarily on potentially risky drug products bought over the Internet.
The investigation found 88 percent of the 2,069 drug packages examined appeared to be prescription medicines available in the United States. Of the remaining products, some were dietary supplements, some were foreign products with labeling that was illegible or incomprehensible, and some were medications not available in the United States. More than half (53 percent) of the products sampled have FDA-approved generic versions, likely sold at lower costs, according to earlier studies that have shown generics in the United States to be generally cheaper than a comparable drug in Canada or Western Europe. In fact, approved generic versions of approximately half (47 percent) of the sampled products can be bought for $4 at several national chain pharmacies, a price often lower than the shipping costs for the same drugs purchased online.
"The data lead us to believe that many people are buying drugs online not to save money but to bypass the need for a prescription from their doctor since these Web sites typically do not require the purchaser to have a prescription," said Randall Lutter, Ph.D., FDA's deputy commissioner for policy. "In essence, they seem to be getting and using prescription drugs without a prescription, an intrinsically risky practice."
link to full article
Sunday, November 04, 2007
Another perfect day...
Back at the Fun E Pharm...The Series...
The real life fictional action drama documentary mini-series that dares to show us the pudgy underbelly of the Life Sciences industry...
Additional links are provided in the sidebar...
Note: Thanks to Motorhead for the insiration for the title...
The Blog rolls have been updated...they were not very up to date to start with, and the existing links were lost during the conversion to the new Blogger update...
A few thoughts...
1- Quantity- Wow, there are a lot more people blogging about this stuff than there used to be...A couple of years ago it was hard to find anyone else covering these topics...(although maybe I just wasn't looking hard enough)...Now you can't swing a WIP sample without hitting another Pharma blog...which is good news, I guess...the more the merrier...
2- That's Punny- There are only so many funny ways you can spin the Pharm/ Farm pun...but that certainly hasn't stopped people from trying...
3- Pharma versus Biotech- There seem to be a lot more people focused on the Pharma market than the Biotech market- Why the distinct separation???- they are converging faster than you think...
4- Corporate Blogs- Congrats to Johnson and Johnson for their "three dimensional view" blog...let's see if anyone follows suit.
Friday, November 02, 2007
Maybe this article will affect the voting for the current Poll question...
WASHINGTON (AP) -- Pharmaceutical sales in the U.S. will drop to a third of global sales in 2008, from a 50 percent share two years ago, a report released Thursday says.
Prescription drugs sales in emerging economies in China, Brazil, Turkey, Mexico and elsewhere are booming but the gains will be offset by the loss of patent protection for profitable drugs worth $20 billion in annual sales in 2008, predicts health care research firm IMS Health.
Expected global sales growth of 5 percent to 6 percent, worth between $735 billion to $745 billion, in 2008 compares with 6 percent to 7 percent growth in 2006 that netted between $695 billion to $705 billion.
In the U.S., prescription drug sales growth of 4 percent to 5 percent, or $295 billion to $305 billion, is forecast by IMS Health.
U.S. patents for Johnson & Johnson's schizophrenia treatment Risperdal and Merck & Co. Inc.'s osteoporosis medicine Fosamax will likely expire, helping drive global sales growth in generic drugs of 15 percent to $70 billion.
IMS expects 29 new drugs to launch next year, but most of them will target less common diseases, not offsetting lost sales of drugs like Merck's Zocor, a widely used cholesterol-lowering drug that lost patent protection this year.
link to full article
Thursday, November 01, 2007
good news for diabetics...
A once-weekly Type II diabetes treatment has shown promise when compared to its twice-daily counterpart.
Amylin Pharmaceuticals, Eli Lilly and Alkermes have developed a long-acting release formulation of exenatide, which is currently marketed as Byetta, a twice-daily injection.
The results from a 30-week comparator study of the two products showed a "statistically significant improvement" in the A1C test, which gives a picture of average blood glucose control over a two to three month period to indicate how well diabetes treatment is working.
According to the companies, the once-weekly formulation showed an improvement in A1C of approximately 1.9 percentage points from baseline, compared to an improvement of approximately 1.5 percentage points for Byetta. Approximately three out of four subjects treated with once-weekly exenatide achieved an A1C of seven per cent or less. A1C of less than seven per cent is the target for good glucose control as recommended by the American Diabetes Association.
During the study, both treatments showed an average weight loss in the subjects of approximately eight pounds.
link to full article