Philly Pharm Bio Blog

What way are we going?

2008-11-17T15:27:00.000-05:00

Which do you think we'll see more off?...

Pfizer Launches Global Regenerative Medicine Research Unit; 70 New Jobs

or

Bristol-Myers Squibb Company Plans $2.5 Billion in Layoffs, Cuts

FDA Warns Public of Extortion Scam by FDA Impersonators

2008-11-13T15:25:00.000-05:00

and you thought all you had to worry about was e-mails from dethroned Nigerian princes...

FDA Warns Public of Extortion Scam by FDA Impersonators

The U.S. Food and Drug Administration is warning consumers about a fraudulent scheme to extort money from consumers by callers who falsely identify themselves as "FDA special agents" or other FDA officials.

Several instances have been reported to the FDA of calls enticing consumers to purchase discounted prescription drugs by wiring funds to one of several locations in the Dominican Republic. No medications are ever delivered. A subsequent call is received from a fraudulent "FDA special agent" informing the consumer that a fine of several thousand dollars is required to be sent to an address in the Dominican Republic to prevent incarceration or other legal action.

"Impersonating an FDA official is a violation of federal law," said Michael Chappell, the FDA's acting associate commissioner for regulatory affairs. "The public should note that no FDA official will ever contact a consumer by phone demanding money or any other form of payment. FDA officials always present identification in person when conducting official business."

Consumers should note that the fraudulent calls appear to be from telephone numbers located within the United States, but are in fact from either ported voice-over-the-Internet-protocol numbers (calls made directly from a computer and moved or "ported" to other computers to avoid detection) or cellular phones. Reports to FDA describe the callers as having Hispanic accents.

link to full article

Phillies win!! Economy doomed?

2008-10-30T14:09:00.000-04:00

It's worth it...every 25 years or so...and this post has all the charts and graphs to prove it...

link to Drug Channels post regarding economic impacts of the Phils winning the Fall Classic

Only 59% of Pharma Companies...

2008-10-29T14:19:00.000-04:00

Own Dedicated Compliance Departments, According to Research by Cutting Edge Information

Can this possibily be correct???...

A stand-alone Quality function is a direct requirement of federal law governing GMP activities...21CFR etc etc etc

I'll have to download the report and read it...that's funny...it's so questionable, I'll take the time to read it...

A new study by business intelligence firm Cutting Edge Information finds that only 59% of pharmaceutical companies currently own dedicated departments for compliance. The study, "Monitoring and Ensuring Pharmaceutical Compliance," highlights the growing need for creating a dedicated compliance department.

With only 59% of pharma maintaining a dedicated department for compliance, there are still a healthy percentage of companies who remain vulnerable to unforeseen regulatory changes. Building a strong compliance management team will give the staff the necessary power to effectively manage their internal clients' changing needs.

Maintaining a dedicated compliance department also signals to outside agencies that the company takes regulation seriously. Giving an outward appearance of a company willing to police itself goes a long way in the court of public opinion. The damage done by a compliance misstep can take a long time to recover from -- both legally and in the eyes of company stakeholders.

link to full article

link to report download

Diabetes drug costs soaring, top $12B last year

2008-10-28T14:16:00.000-04:00

I think they've found the new blockbuster...

Americans with diabetes nearly doubled their spending on drugs for the disease in just six years, with the bill last year climbing to an eye-popping $12.5 billion.

Newer, more costly drugs are driving the increase, said researchers, despite a lack of strong evidence for the new drugs' greater benefits and safety. And there are more people being treated for diabetes.

The new study follows updated treatment advice for Type 2 diabetes, issued last week. In those recommendations, an expert panel told doctors to use older, cheaper drugs first.

And a second study, also out Monday, adds to evidence that metformin — an inexpensive generic used reliably for decades — may prevent deaths from heart disease while the newer, more expensive Avandia didn't show that benefit.

"We need to pay attention to this," said Dr. David Nathan, diabetes chief at Boston's Massachusetts General Hospital, who wrote an editorial but wasn't involved in the new studies. "If you can achieve the same glucose control at lower cost and lower side effects, that's what you want to do."

The studies, appearing in Monday's Archives of Internal Medicine, were both funded by federal grants.

link to full article

China arrests 6 for role in contaminating milk

2008-10-23T13:28:00.000-04:00

How many points in this story make no sense?...the over-under is 4...

BEIJING – China arrested three people Thursday for allegedly adding a toxic chemical to fresh milk to mask the fact that it was watered down and three others for selling the chemical.

The practice of adding melamine, a nitrogen-rich substance used in making plastics and fertilizers, to milk supplies is blamed for killing four babies in China and sickening tens of thousands.

The babies were sickened by powdered infant formula that authorities believe was made from tainted fresh milk. Melamine has also been found in other Chinese dairy products, including yogurt, candy and cream cookies.

More than 3,654 Chinese children remain hospitalized for kidney stones or other symptoms caused by ingesting melamine, the Health Ministry said Thursday. Three were in serious condition.

The official Xinhua News Agency said all six suspects arrested Thursday worked in Inner Mongolia, a region of sprawling grasslands that has become China's dairy heartland. Countless small dairy farms dot the grasslands, with milk collected at stations and then sold to large dairy companies.

One suspect, identified by Xinhua only by his surname Cui, ran a collection station and allegedly confessed to mixing about 25 gallons of water to 544 gallons of fresh milk. He then added 21 ounces — about three or four cups — of fake protein, which contained melamine, to hide the fact that it was diluted.

link to full article

Many biological medicines draw safety warnings

2008-10-22T11:47:00.000-04:00

Why does follow-on monitoring for safety seem like such a strange idea?...

WASHINGTON, Oct 21 (Reuters) - About a quarter of biological medicines approved in the United States and Europe since 1995 have triggered safety warnings in the years after entering the market, Dutch researchers said on Tuesday.

Immune system disorders, infusion reactions, infections and cancer concerns were among the reasons for safety warnings for biological medicines, which are made with proteins derived from living cells rather than the chemicals used in typical drugs.

These medicines, called biologics or biologicals, are typically injected and treat a range of conditions including anemia, rheumatoid arthritis, hepatitis and cancer.

Thijs Giezen of Utrecht University in the Netherlands and colleagues tracked safety-related regulatory actions involving 174 biological medicines approved in the United States or the European Union between January 1995 and June 2007.

link to full article

Counterfeiters can get life in jail under new US Act

2008-10-20T15:10:00.000-04:00

US President George W Bush has signed a bill under which counterfeiters can be sentenced to life imprisonment if their crime causes the death of an individual.

The passing of the Prioritizing Resources and Organization for Intellectual Property Act of 2007 (PRO IP) strengthens the US court’s power to punish those convicted of counterfeiting; a measure big pharma has been calling for.

By increasing its maximum penalty the US has brought its punishment more closely into line with China, which sentenced a man to life in prison for causing 14 deaths by using a fake ingredient in human immunoglobulin.

The sentence for inflicting serious bodily harm as a result of counterfeit products has also been increased and can now result in up to 20 years in jail. Both sentences can also carry a fine.

In addition to increasing the punishments for trafficking counterfeit goods the new legislation also ramps up US preventative powers.

link to full article

Chinese government summons major dairy companies

2008-10-17T13:54:00.000-04:00

to buy up the plants of the company that produced contaminated milk...somehow these facilties have "great value"???...

BEIJING – China summoned five of its major dairy companies to a meeting Friday over the fate of Sanlu Group Co., the company at the center of a tainted milk scandal that has sickened thousands and led to the deaths of four children, state media reported.

The five companies were brought to Beijing to discuss the purchase of the company, the 21st Century Business Herald, a major business daily, reported Friday.

The government is trying to revive its dairy industry and contain the fallout after baby formula contaminated with melamine was blamed for the deaths of four infants and the sickening of about 54,000 other children in China.

The Health Ministry said Wednesday that 5,800 children were still hospitalized — six of them in serious condition. In Hong Kong, the Department of Health said Friday two more children have developed kidney stones after drinking melamine-laced milk, bringing to 10 the total number of children with milk-related kidney stones.

Sanlu, a majority state-owned company whose products were the most heavily tainted, is now largely defunct, with companies looking to scoop up its assets.

link to full article

Results are In: Pharma Favors Obama

2008-10-15T15:52:00.000-04:00

I don't normally discuss politics at work, but...

an interesting post over at Pharma Marketing blog...

US proposes country-of-origin labelling

2008-10-14T15:18:00.000-04:00

A good start...we have to start protecting ourselves...

A bill has been introduced to the US Senate that would require the country-of-origin of APIs and excipients to be labeled on finished dosage forms.

This proposal covers both active pharmaceutical ingredients (APIs) and excipients present in prescription or over-the-counter (OTC) products.

Including excipients under the bill differentiates it from the proposal in the draft of the US Food and Drug Administration (FDA) Globalization Act, which was released in April.

Under the proposal the country-of-origin of each active and inactive ingredient would be listed in descending order based upon the quantity in the finished dose.

It appears that it will not be necessary to include the country of origin of all raw materials and intermediates, or the nation in which every step in the synthesis process occurs.

This would provide a more comprehensive view of the origins of an API or excipient but is not mentioned in the bill, probably due to the complexity of implementing such a measure.

link to full article

China orders more testing for liquid milk, powder

2008-10-14T15:17:00.000-04:00

BEIJING - China is ordering all liquid and powdered milk manufactured before Sept. 14 to be taken off the shelves for melamine testing, a news report said Tuesday, the first time Beijing has issued a blanket recall of products since the tainted dairy scandal broke last month.

It is the latest in a series of measures China has taken to allay worries over the quality of Chinese products and restore consumer confidence since four babies died and tens of thousands of children were sickened after drinking tainted milk.

Authorities have blamed dairy suppliers for the crisis, saying they added the industrial chemical melamine to watered-down milk to fool quality control tests and make the product appear rich in protein.

Melamine can cause kidney stones as the body tries to eliminate it and, in extreme cases, lead to life-threatening kidney failure.

Citing a notice jointly approved by six government ministries and administrations, the official Xinhua News Agency said Tuesday that all milk powder and liquid milk produced before Sept. 14 must be subject to testing nationwide by manufacturers.

link to full article

Opportunity Knocks for Big Pharma in Credit Crunch

2008-10-09T13:27:00.000-04:00

A good article regarding the impacts of the economic situation on the Pharma market over at FierceBiotech...

The primary consequence of the credit crunch for non-financial companies is the loss of access to cheap debt

LONDON, Oct. 8, 2008- The key impact of the credit crunch on the corporate world is the abrupt loss of cheap debt. During the late 1990s and 2000s companies across all industries have exploited easy access to cheap debt to amplify or ‘leverage' their return to investors. However, triggered by the sub-prime crisis and the subsequent collapse of big name financial institutions, banks have no choice but to protect their own capital and stop lending - turning off this supply of cheap debt.

This leaves those companies that have taken on debt in the extremely uncomfortable position of having to either rapidly pay off their debts (‘deleveraging') or re-secure new debt at much higher interest rates - potentially threatening the viability of the firm. Datamonitor believes that large pharmaceutical companies have wisely stayed out of the cheap debt game and as a result, the credit crunch will actually play out as a net positive for an industry much in need of good news, according to Datamonitor head of company analysis Dr. Chris Phelps. "Pharma companies are not only expected to weather the financial storm successfully but to also use this period to exploit their unique cash strength by embarking on an acquisition spree."

link to full article

China detains 6 more suspects in milk scandal

2008-10-06T15:25:00.000-04:00

You can't "check Quality into" a product...

Maybe you can "arrest Quality into" a product...

BEIJING - China pledged to improve food safety after authorities detained six more people in the country's contaminated milk scandal as the government increases efforts to restore public trust in Chinese-made food products.

The head of China's quality watchdog said the country is also stepping up checks on its exports to ensure they conformed to the food safety standards of recipient countries, the official Xinhua News Agency reported.

The Chinese government has been scrambling to show it is tackling the problem of melamine-contaminated milk powder and products blamed for killing four babies and sickening more than 54,000 children with kidney stones and other illnesses in China.

"Food safety concerns not only the health of the public, but also the life of business," said Wang Yong, the director of the General Administration of Quality Supervision, Inspection and Quarantine, the agency responsible for ensuring that China's food supply chain is safe.

Wang, who replaced Li Changjiang, the former director who resigned last month in the wake of the scandal, vowed to make "a substantial change in the production and distribution of dairy products."

link to full article

Candy with chemical in Chinese milk found in Conn.

2008-10-02T15:21:00.000-04:00

And now we have to deal with it...

But look closely at Paragrapgh 9...when does it change from a few rogue companies contaiminating a product to "Standard Operating Procedure"???...

HARTFORD, Conn. - An industrial chemical blamed for sickening thousands of infants in China was found in candy in four Connecticut stores this week, a state official said Wednesday.

Days after contaminated White Rabbit Creamy Candy was found in California, Connecticut Consumer Protection Commissioner Jerry Farrell Jr. said tests found melamine in bags of the candy sold at two New Haven stores, a West Hartford market and an East Haven store.

"We're concerned, obviously, there may have been bags sold of these before we got to them," Farrell said.

Anyone who has the candy should destroy it, Farrell said.

The contamination has been blamed for the deaths of four children and kidney ailments among 54,000 others. More than 13,000 children have been hospitalized and 27 people arrested in connection with the tainting.

Melamine, which is high in nitrogen, is used to make plastics and fertilizers and experts say some amount of the chemical may be transferred from the environment during food processing. But in China's case, suppliers trying to boost output are believed to have diluted their milk, adding melamine because its nitrogen content can fool tests aimed at verifying protein content.

Melamine can cause kidney stones, leading to kidney failure. Infants are particularly vulnerable.

Melamine has been associated with contaminated infant formula and other Chinese products containing milk protein.

On Wednesday, the Chinese government identified 15 more Chinese dairy companies as producing milk products contaminated with melamine, bringing the total to 20 companies. At least 100 batches of milk powder have been found to contain the chemical, according to data on the food safety administration's Web site.

link to full article

FDA faulted for produce oversight

2008-09-29T15:44:00.000-04:00

Who plans a "foodborne illness outbreak"???...

WASHINGTON (Reuters) - Preparations for a biological attack and repeated outbreaks of food poisoning have interfered with efforts by the U.S. Food and Drug Administration to improve the safety of fresh produce, according to a report released on Friday.

The agency is also unclear on what it plans to do to shape up, the Government Accountability Office said.

"While FDA has considered fresh produce safety a priority for many years, resource constraints and other work -- including counterterrorism efforts and unplanned events such as foodborne illness outbreaks -- have caused FDA to delay key produce safety activities," the GAO report reads.

"FDA has no formal program devoted exclusively to fresh produce and has not consistently and reliably tracked its fresh produce spending."

It said the FDA spent at least $20 million or about 3 percent of its food safety dollars on fresh produce in 2007.

The fresh produce industry has indicated it would welcome stronger regulation, especially after outbreaks of Salmonella carried by peppers from Mexico and that sickened 1,400 people from April to August of this year and an E. coli epidemic in 2006, traced to California spinach, that killed three.

link to full article

Rest of Sanofi's contaminated Lovenox recalled

2008-09-23T15:30:00.000-04:00

The heparin saga continues...

PARIS, Sept 23 (Reuters) - French drugmaker Sanofi-Aventis (SASY.PA: Quote, Profile, Research, Stock Buzz) has recalled remaining batches of contaminated blood thinner Lovenox, a heparin, which were distributed before May 2008, French drug regulator Afssaps said.

Earlier this year, high levels of contamination with an oversulphated chondroitin sulphate in different types of heparin -- derived from pig intestines and used to prevent and treat blood clots -- were linked with serious side effects and deaths.

No such side effects were observed with Sanofi's Lovenox and the European Medicines Agency said in June doctors in Europe could continue to use the drug despite low levels of contamination found in some batches of the product.

link to full article

China's food safety chief quits over tainted milk

2008-09-22T13:24:00.000-04:00

Four children dead, over 50,000 sick...this helps how?

BEIJING - The head of the Chinese agency that monitors food and product safety has resigned, state media announced Monday, pushed out by a scandal over tainted baby formula that killed four babies and sickened nearly 53,000.

Beijing authorities also said that China's biggest producer of powdered milk had known for months that its baby formula was tainted with the industrial chemical melamine. There were complaints about infant formula sold by the Sanlu Group Co. as early as December, 2007, China Central Television reported, citing an investigation by the State Council, China's Cabinet.

"During these eight months, the company did not inform the government and did not take proper measures, therefore making the situation worse," CCTV said.

Melamine, which can cause kidney stones and kidney failure in babies, has since been found in infant formula and other milk products from 22 of China's dairy companies.

link to full article

Australia issues first license to clone human embryos

2008-09-18T14:58:00.000-04:00

Is this the beginning of the Brave New World?...

SYDNEY (Reuters) - The Australian government has issued its first license allowing scientists to create cloned human embryos to try and obtain embryonic stem cells.

The in vitro-fertilization firm Sydney IVF was granted the license and reportedly has access to 7,200 human eggs for its research.

If the firm is successful it would be a world first, the Australian government's National Health and Medical Research Council (NHMRC), which granted the license, said on Wednesday.

Scientists in other countries have made stem cells they believe are similar to embryonic cells using a variety of techniques, but none have been able to extract embryonic stem cells from cloned human embryos.

link to full article

6,200 Chinese babies ill, 3 die from tainted milk

2008-09-17T14:47:00.000-04:00

and so it continues...

BEIJING - The government was dispatching thousands of inspectors to monitor producers as officials reported Wednesday that the number of babies sick from tainted milk formula had climbed dramatically to nearly 6,200 from 1,200 a day earlier.

At least three children have died and more than 1,300 others, mostly newborns, remain hospitalized with dozens suffering from acute kidney failure.

Health Minister Chen Zhu said he expected the numbers of affected babies to increase as "more and more parents take kids to the hospital."

The head of China's quality control watchdog agency, Li Changjiang, said 5,000 inspectors will be sent out nationwide to monitor companies after government testing showed that 20 percent of the companies producing milk powder had dairy products with melamine.

link to full article

China makes first arrests in tainted milk probe

2008-09-15T14:24:00.001-04:00

Update

China finds more tainted dairy products

Probe finds 20 percent of China milk companies in scandal

Baby Milk? Baby Milk?

Apparently, this was a deliberate act...

When will we come to realize that these people have NO scuples whatsoever...

China launches nationwide baby formula probe

China makes first arrests in tainted milk probe

New GMP Regs

2008-09-11T13:59:00.000-04:00

The FDA has responded to industry comments with some new rules...

FDA publishes final rule on cGMP amendments

Biologists on the Verge of Creating New Form of Life

2008-09-09T13:40:00.000-04:00

A team of biologists and chemists is closing in on bringing non-living matter to life.

It's not as Frankensteinian as it sounds. Instead, a lab led by Jack Szostak, a molecular biologist at Harvard Medical School, is building simple cell models that can almost be called life.

Szostak's protocells are built from fatty molecules that can trap bits of nucleic acids that contain the source code for replication. Combined with a process that harnesses external energy from the sun or chemical reactions, they could form a self-replicating, evolving system that satisfies the conditions of life, but isn't anything like life on earth now, but might represent life as it began or could exist elsewhere in the universe.

While his latest work remains unpublished, Szostak described preliminary new success in getting protocells with genetic information inside them to replicate at the XV International Conference on the Origin of Life in Florence, Italy, last week. The replication isn't wholly autonomous, so it's not quite artificial life yet, but it is as close as anyone has ever come to turning chemicals into biological organisms.

"We've made more progress on how the membrane of a protocell could grow and divide," Szostak said in a phone interview. "What we can do now is copy a limited set of simple [genetic] sequences, but we need to be able to copy arbitrary sequences so that sequences could evolve that do something useful."

By doing "something useful" for the cell, these genes would launch the new form of life down the Darwinian evolutionary path similar to the one that our oldest living ancestors must have traveled. Though where selective pressure will lead the new form of life is impossible to know.

"Once we can get a replicating environment, we're hoping to experimentally determine what can evolve under those conditions," said Sheref Mansy, a former member of Szostak's lab and now a chemist at Denver University.

Protocellular work is even more radical than the other field trying to create artifical life: synthetic biology. Even J. Craig Venter's work to build an artificial bacterium with the smallest number of genes necessary to live takes current life forms as a template. Protocell researchers are trying to design a completely novel form of life that humans have never seen and that may never have existed.

link to full article

FDA to List Drugs Being Investigated

2008-09-08T14:33:00.000-04:00

Talk about "Direct to Consumer" marketing...this sound like "do it yourself" drug safety review...

The Food and Drug Administration will begin posting every three months a list of drugs whose safety is under investigation because of complaints brought to the agency's attention by drug companies, physicians and patients.

The FDA will name the drug and the nature of the "adverse events" but will not describe their seriousness or the number of complaints received, officials said yesterday. Being on the list does not mean the drug is unsafe, only that the FDA is looking into that possibility.

FDA officials said they realize that the new policy, required by changes to federal law enacted last year, may unintentionally alarm some patients.

The agency's Adverse Event Reporting System (AERS) last year received 482,154 unsolicited reports of potential reactions to drugs. The vast majority were false alarms, with the reported problem having nothing to do with the medication a patient was taking.

link to full article

Meaningless genetic code helped form human hands

2008-09-05T14:52:00.000-04:00

Genetic code once written off as meaningless is today show to have played a potential role in the evolution of the human ability to hold tools and walk upright.

The study is the latest in a long line of evidence to show that the genetics textbooks will have to be rewritten.

It underlines how, even though the human genetic code was read letter by letter for the first time in 2000, geneticists are still struggling to figure out what it means almost a decade later.

When scientists refer to genes, they mean stretches of DNA code that contain the instructions to make the proteins that build and operate the body.

When the genome was first unveiled, it was thought all human genes resided in only around 1.5 per cent of the cell's DNA, prompting some scientists so dismiss the other 98.5 per cent as "junk".

link to full article

Building boom meets maturing biotechs’ needs

2008-09-02T14:54:00.000-04:00

Looking for biotech work?...go west, young man/ lady...

Even with some 1 million square feet of biotech office or R&D space on the Peninsula’s leasing market today, developers plan on bringing another 2.3 million square feet to the market over the next year or two.

The reason, say developers, brokers and biotech leaders, is simple: There’s still a need for space to match a maturing Bay Area biotech community. Still, developers are moving cautiously, building mostly to suit tenants and not getting too far in front of an industry known for stunning successes and equally brilliant burnouts.

“There’s always opportunity out there,” said Jennifer Von der Ahe, a project manager for Chamberlain Associates, which is developing more than 185,000 square feet in South San Francisco for neurological drugs maker Elan Corp.

“Biotech is not going away.”

link to full article

Producing heparin without the heartache

2008-08-27T15:47:00.000-04:00

or without the Chinese deliberatley substtituing chemical contamination in lieu of actually producing the product they were paid to produce...but, hey, who's quiblling over details...

US researchers have developed a chemoenzymatic strategy to synthesise the anticoagulant drug heparin and avoid the contaminant that has killed more than 80 people.

The breakthrough was presented at the ACS (American Chemical Society) National Meeting and Exposition in Philadelphia, US, earlier this week and described how Escherichia coli (E. coli) bacteria could be harnessed to synthesise the widely-used anticoagulant that has global annual sales of around $4bn (€2.7bn).

Heparin is produced by extraction from pig intestines and contaminated batches of the drug have been linked by the US FDA (Food and Drug Administration) to more than 80 deaths and hundreds of allergic reactions among patients treated with the drug during heart surgery and kidney dialysis.

The contaminated heparin was traced by the FDA to various batches imported from small, family-run workshops in China which supply about 70 per cent of the world’s supply.

While regulators called for greater cooperation and joint inspections of overseas active pharmaceutical ingredient (API) manufacturing plants, Professor Robert Linhardt of the Rensselaer Polytechnic Institute, US, and Associate Professor Jian Liu of the University of North Carolina, US, to search for an alternative method of production.

Prof. Linhardt was part of the team that identified the suspected contaminant as a structurally similar carbohydrate called oversulfated chondroitin sulfate.

"When we found the contamination, it was another sign that the way we currently manufacture heparin is simply unsafe," said Prof. Linhardt.

Researchers have been trying for years to develop a synthetic production method for the drug, however the first total synthesis described in 2003 by researchers from the Massachusetts Institute of Technology (MIT), US, produced only minute batches at a time and could not be economically scaled-up for commercial production.

The synthesis developed by Prof. Linhardt’s team uses a patented biosynthesis that uses enzymes expressed in E. coli bacteria to replicate the normal biosynthesis of natural heparin.

While the team has only used the technique to create the drug on a laboratory scale, scaling the process up should prove no more difficult than scaling-up the production of any other biological drug.

The group plans to begin the necessary preclinical and clinical trials needed to bring the synthetic heparin to market. If successful, the new heparin could be on the market in two to five years.

link to full article

FDA seizes drugs worth $74,000

2008-08-26T16:20:00.000-04:00

How come we can't get this level of enforcement on real drugs??...

The US Food and Drug Administration (FDA) has ordered the seizure of $74,000 worth of Xiadafil VIP tablets after SEI Pharmaceuticals refused to withdraw them from the market.

A formal request for the recall of the erectile dysfunction dietary supplement was issued by the FDA after it discovered batches contained an undeclared active pharmaceutical ingredient (API).

SEI refused to recall the products leading to the FDA enlisting US Marshals to seize the batches to prevent more illegal Xiadafil from being sold.

Margaret Glavin, associate commissioner of the FDA’s Office of Regulatory Affairs, said: “Today’s seizure action shows that the FDA will take enforcement action to protect the public from dietary supplements that contain prescription drug ingredients that are potentially harmful to consumers.

“The FDA will not tolerate a company’s failure to take voluntary action to protect the public health after being given the opportunity by the FDA to do so.”

link to full article

Gene found for rare and deadly childhood cancer

2008-08-25T14:08:00.000-04:00

News out of CHOP...

WASHINGTON (Reuters) - Researchers have found a gene that causes most inherited forms of neuroblastoma, a rare and deadly form of childhood cancer, and say the discovery points to new treatments.

Mutations in a gene called ALK were strongly linked to neuroblastoma, the researchers from the United States, Italy and Belgium reported on Sunday. They said several companies already are working on drugs that target this gene, which is also mutated in some cases of lung cancer and lymphoma.

"This discovery enables us to offer the first genetic tests to families affected by the inherited form of this disease," said Dr. Yael Mosse of The Children's Hospital of Philadelphia, who worked on the study.

"Furthermore, because there already are drugs in development that target the same gene in adult cancers, we can soon begin testing those drugs in children with neuroblastoma."

link to full article

Stem cell advance may help transfusion supplies

2008-08-19T15:56:00.000-04:00

Don't tell Northfield or Biopure...

NEW YORK - Scientists say they've found an efficient way to make red blood cells from human embryonic stem cells, a possible step toward making transfusion supplies in the laboratory. The promise of a virtually limitless supply is tantalizing because of blood donor shortages and disappointments in creating blood substitutes.

Red blood cells are a key component of blood because they carry oxygen throughout the body.

Experts called the new work an advance, but cautioned that major questions had yet to be answered.

The research, published online Tuesday by the journal Blood, was reported by scientists at Advanced Cell Technology in Worcester, Mass., the University of Illinois at Chicago and the Mayo Clinic in Rochester, Minn.

link to full article

Budget Juggling...

2008-08-18T16:06:00.000-04:00

Maybe everybody who lose's their job at the NIH...Slowdown In National Institutes of Health (NIH) Funding Creates 'Quiet Crisis'

Can get a job with the FDA...Agency To Add More Than 1,300 Scientists

Researchers Correct Decline In Organ Function Associated With Old Age

2008-08-12T15:01:00.000-04:00

Hurry Up!!!

As people age, their cells become less efficient at getting rid of damaged protein — resulting in a buildup of toxic material that is especially pronounced in Alzheimer's, Parkinson's disease, and other neurodegenerative disorders.

Now, for the first time, scientists at the Albert Einstein College of Medicine of Yeshiva University have prevented this age-related decline in an entire organ — the liver — and shown that, as a result, the livers of older animals functioned as well as they did when the animals were much younger. Published in the online edition of Nature Medicine, these findings suggest that therapies for boosting protein clearance might help stave off some of the declines in function that accompany old age. The study's senior author was Dr. Ana Maria Cuervo, associate professor in the departments of developmental & molecular biology, medicine and anatomy & structural biology at Einstein.

link to full article

Heparin taint tied to deaths

2008-07-30T14:44:00.000-04:00

FDA: 3 fatalities linked to material in Baxter product

The U.S. Food and Drug Administration, for the first time, has conclusively linked deaths of patients infused with the blood thinner heparin to a foreign substance found in specific lots of the drug made by Deerfield-based Baxter International Inc.

In an interview Tuesday with the Tribune, the FDA said it completed its review of 93 death reports related to heparin that the agency received from Jan. 1 to March 31, a period when there was a dramatic spike in potentially deadly allergic reactions from patients who had been injected with heparin. The popular blood thinner is used widely in large dosages, often before patients have dialysis or heart surgery.

Of 10 reports of death from severe shock known as anaphylaxis or hypotension, three of those could be traced to lot numbers of Baxter products that tested positive for an animallike substance known as oversulfated chondroitin sulfate. Heparin lot numbers were not known for the other seven deaths from anaphylaxis or hypotension, so the FDA could not determine whether those 7 patients received heparin contaminated with the substance.

"We have what looks like a cause and effect in some patients," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in an interview, referring to the three deaths linked to contaminated heparin. "We know that they got contaminated heparin, and they died subsequently. This is one of the final links in the chain."

link to full article

Good and Evil: A Cancer Vaccine from Tobacco Plants

2008-07-24T15:13:00.000-04:00

Tobacco makes a comeback!!!

In the first human trial of its kind, a vaccine grown in genetically engineered tobacco plants has proved to be safe, paving the way to one day use it to help combat a potentially fatal form of non-Hodgkin's lymphoma.

Researchers report in the Proceedings of the National Academy of Sciences USA that the experimental vaccine triggered the immune systems of 11 of 16 volunteers (with so-called follicular B-cell lymphoma) to attack their tumors without any apparent dangerous side effects.

Some 18,000 Americans, typically between the ages of 60 and 65, are diagnosed annually with this incurable, slow-growing type of cancer. Study coauthor Ronald Levy, an oncologist at the Stanford University School of Medicine, says that physicians generally take their cues from the disease, waiting to see how fast it is moving—and treating it with toxic chemotherapy (sometimes with radiation) only if it becomes aggressive.

He says that if future trials are successful, the experimental vaccine, which can be made relatively quickly and cheaply, could become a short-term therapy administered immediately after diagnosis to try to keep tumors in check.

"This may not be a replacement for chemotherapies, but a supplement for them," Levy says. "A technology that is fast, like this one, is more amenable to a watchful waiting approach than a technology that is slow to produce."

link to full article

Senate Appropriations Committee Approves $2 Billion for FDA

2008-07-21T12:03:00.000-04:00

Now they're gonna regulate the #@&?#!!! out of us...

The Senate Appropriations Committee unanimously passed an appropriations markup measure Thursday, providing the FDA with a $2.04 billion fiscal 2009 budget.

This amount is $324.6 million more than the agency initially received for fiscal 2008. The measure will have no number until it is introduced in the full Senate.

link to full article

FDA Moves Forward With Exempting Phase I Drugs From GMPs

2008-07-17T13:26:00.000-04:00

So much for those bothersome regulations...

More than two years after withdrawing a final rule that would have exempted investigational drugs in Phase I testing from certain good manufacturing practice (GMP) regulations, the FDA is issuing a final rule to do just that.

The new rule, which amends the GMP regulation with the exact same language as the withdrawn rule, was published in Tuesday’s Federal Register. Slated to take effect Sept. 15, it will apply to small-molecule drugs and biologics, including vaccines and gene therapy products.

“FDA’s position is that the United States’ [GMP] regulations were written primarily to address commercial manufacturing and do not consider the differences between early clinical supply manufacture and commercial manufacture,” the agency says.

link to full article

Even India is slowing down!!!

2008-07-16T14:03:00.000-04:00

Biotech growth slows for first time in 5 years

Bangalore: After five straight years of rapid expansion, India’s biotechnology industry slowed to 20% growth in the year to March, down from more than 30% in the previous years, largely due to a rising rupee and price pressures in the global market.

link to full article

NJ to lose more than 800 pharmaceutical jobs

2008-07-09T15:05:00.000-04:00

New Jersey gets pounded!!!...

More than 800 pharmaceutical jobs leaving New Jersey as part of major restructuring

NEW YORK (Associated Press) - More than 800 pharmaceutical jobs will be leaving New Jersey starting in August.

Most of the job cuts and transfers are part of major previously announced restructurings at Johnson & Johnson and Schering-Plough Corp. This week, the companies specified how many of those jobs would be lost at New Jersey locations.

Schering-Plough, based in Kenilworth, is cutting 500 jobs. New Brunswick-based J&J is eliminating 22 jobs at its Ortho Biotech unit in Bridgewater, shifting another 260 to its Centocor unit in Horsham, Pa., and cutting another 267 Ortho Biotect jobs outside New Jersey.

link to full article

The Race to China

2008-07-08T14:14:00.000-04:00

Interesting post from Pharmalot regarding Pharma's move to China...

I understand the drivers behind these types of efforts, something to spruce up yet another bland corporate report,...something for senior management to tout as "the strategy"...reducing the costs of an already ineffective R+D effort, etc, etc...

These drivers will have more and more companies jumping on the bandwagon...

How many of these companies are backing up these efforts with a robust plan for maintaining the quality of the products they intend to produce?...and yes, that includes research efforts...or are they just looking at the cost savings?...

Study finds long benefit in illegal mushroom drug

2008-07-02T12:55:00.000-04:00

Maybe this accounts for all those nice people you meet...

NEW YORK - In 2002, at a Johns Hopkins University laboratory, a business consultant named Dede Osborn took a psychedelic drug as part of a research project.

She felt like she was taking off. She saw colors. Then it felt like her heart was ripping open.

But she called the experience joyful as well as painful, and says that it has helped her to this day.

"I feel more centered in who I am and what I'm doing," said Osborn, now 66, of Providence, R.I. "I don't seem to have those self-doubts like I used to have. I feel much more grounded (and feel that) we are all connected."

Scientists reported Tuesday that when they surveyed volunteers 14 months after they took the drug, most said they were still feeling and behaving better because of the experience.

link to full article

The Gates Foundation: Dissatisfied With Results?

2008-07-01T14:57:00.000-04:00

An interesting post from In The Pipeline...regarding the Gates Foundation

I guess I always assumed Bill would be just as successful in medicine as his other endeavors...

Enjoy...

'Designer baby' to be free from breast cancer

2008-06-30T15:10:00.000-04:00

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.

link to full article

The Fierce 15 is out!!!

2008-06-27T13:48:00.000-04:00

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

2008-06-26T14:22:00.000-04:00

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%

2008-06-25T14:22:00.000-04:00

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."

link to full article

News from BIO 2008

2008-06-24T13:34:00.000-04:00

BIOTECH: Artificial embryonic cells fuel research 'explosion'

BIO 2008 website

Drugmakers: Prepare for a Smackdown

2008-06-23T14:22:00.000-04:00

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

2008-06-10T13:16:00.000-04:00

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

link to full article

FDA: 11 Deaths In Medical Devices Tied To Heparin

2008-06-09T15:07:00.000-04:00

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

2008-06-03T14:00:00.000-04:00

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

2008-06-02T14:52:00.000-04:00

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

BioKinetics launches E-Learning Service

2008-05-22T12:53:00.000-04:00

BioK has a new service...

Online training for the process side of the GMP industry...

Previews are available for 2 courses...

Check it out...

Google releases Google Health for medical records

2008-05-20T12:33:00.000-04:00

NEW YORK/SAN FRANCISCO (Reuters) - Google Inc on Monday unveiled Google Health, a long-anticipated U.S. health information service that combines the leading Web company's classic search services with a user's personal health records online.

The password-protected service, which can be found at www.google.com/health/, stores a user's basic medical history and gathers relevant information connected to their health conditions.

One feature includes a link to help users find doctors by location or specialization. The "virtual pillbox" notifies patients when they need to take medications and warns of potential drug interactions.

The service includes links to major U.S. pharmacies, doctors' groups and medical testing labs.

link to full article

Chinese SFDA crackdown to get house in order

2008-05-19T15:03:00.000-04:00

The Chinese State Food and Drug Administration (SFDA) has revealed plans to tighten the drug registration review process as it attempts to improve standards in the nation.

At the regulatory body's monthly press conference a SFDA spokesman spelt out the policy which will only allow drug companies one opportunity to file their application documents.

By adopting a hard line stance the SFDA is sending out a strong message to its critics both at home and abroad who have cast aspersions on the integrity of the registration process.

SFDA spokesperson Yan Jiangying said: "In cases where a company's application does not satisfactorily prove the safety and efficacy of its product, the SFDA will no longer ask for further information, unlike in the past, but will simply reject the application outright."

This shift in policy is the result of an in-depth review of documents submitted to the SFDA between January and April this year to verify all information in the applications through pharmacological, toxicological and clinical trial analysis.

From this the SFDA discovered that some of the drug application documents were quite similar, which it believes is likely to signify that the company has fabricated the data.

link to full article

Pfizer to build Irish biologics plant

2008-05-12T15:35:00.000-04:00

07-May-2008 - Pfizer's plans for a new €190m manufacturing plant in Shanbally, Ireland suggest that the firm is intent on fulfilling its pledge to become a "top five biologics producer in the next eight years."

The facility will produce small quantities of candidate drugs for clinical trials, creating around 100 jobs when it becomes operational at the end of 2009. It will be built on the 28-acre vacant lot adjacent to Pfizer's existing Ringaskiddy manufacturing unit that has been the subject of much speculation since the firm applied for planning permission last summer.

Pfizer spokeswoman Tara Delaney told in-PharmaTechnologist.com that the unit will "manufacture and purify a variety of mammalian cell derived proteins at pilot scale on behalf of PGR&D [Pfizer Global Research and Development]," She went on to say that Jacobs Engineering will manage the construction project but added that it was too early to discuss the specific facilities that will be available at the site.

link to full article

and Here We Go...

2008-05-06T21:38:00.000-04:00

The Chinese start the "active evasion" portion of this tragedy...asking if people who were taking a drug used in dialysis had kidney disease...

China accuses US of shoddy probe into tainted heparin

BEIJING - China's drug safety agency accused the United States on Tuesday of blocking Beijing's inquiry into a blood thinner linked to 81 deaths by refusing to provide details on victims and specifics about production.

Two Chinese experts who attended a conference on the drug, heparin, in suburban Washington, D.C., last month said the U.S. determined a contaminant was likely to blame without considering other possible factors.

"We need to resolve this in a scientific matter, not just by blaming a contaminant," said Jin Shaohong, a member of the drug evaluation committee of China's Food and Drug Administration. "I think it is too early to say that."

Besides the deaths, hundreds of patients have suffered severe allergic reactions to large doses of heparin, which is used in dialysis and other treatments.

The U.S. Food and Drug Administration said it suspects the problems stem from a contaminant the agency discovered in supplies of raw heparin coming from China — a compound derived from animal cartilage that so closely mimics heparin that routine tests can't detect it.

The Chinese experts said U.S. officials and Baxter International refused to give them information to probe the possibility that drug interactions, patients' medical histories or safety issues after the raw material left China may have played a role.

link to full article

Report: Risky tests of blood substitutes allowed

2008-04-29T15:40:00.000-04:00

The products in question here are very different from each other...

Pooling data would make almost no sense...safety trials would be a good idea, which the FDA strongly recommended, and they enforced their own recommendation...check the timing of Biopure's stock dropping several years ago as compared with the FDA response letter...

other details gets washed over in this article as well...

FDA permitted human testing despite warning signs, report charges

CHICAGO - Experimental blood substitutes raised the risk of heart attack and death, yet U.S. regulators allowed human testing to continue despite warning signs, says a scathing new report.

The U.S. Food and Drug Administration fell short, the report contends, even as red flags popped up during studies by five biotech companies. Rules barred the agency from releasing company trade secrets, and that kept some information hidden and may have led to unnecessary heart attacks and deaths, wrote the authors, who are government scientists and consumer advocates.

“There shouldn’t be secret science,” said the lead author of the report, Dr. Charles Natanson, of the National Institutes of Health Clinical Center. Safety data need “to be made public expeditiously so science can build on the mistakes” of previous research, he said.

link to full article

Study says near extinction threatened people 70,000 years ago

2008-04-26T08:11:00.001-04:00

I find this type of stuff fascinating...

image from National Geographic

WASHINGTON - Human beings may have had a brush with extinction 70,000 years ago, an extensive genetic study suggests. The human population at that time was reduced to small isolated groups in Africa, apparently because of drought, according to an analysis released Thursday.

The report notes that a separate study by researchers at Stanford University estimated the number of early humans may have shrunk as low as 2,000 before numbers began to expand again in the early Stone Age.

"This study illustrates the extraordinary power of genetics to reveal insights into some of the key events in our species' history," Spencer Wells, National Geographic Society explorer in residence, said in a statement. "Tiny bands of early humans, forced apart by harsh environmental conditions, coming back from the brink to reunite and populate the world. Truly an epic drama, written in our DNA."

link to full article

other links

National Geographic- The Genographic Project

IBM- The Genographic Project

Heparin Recall Update

2008-04-26T08:04:00.002-04:00

The Chinese delegation visited the Baxter site in Cherry Hill last week...and there hasn't been much follow-up in the press...

It was heard that that the Chinese requested samples of the product in question in order that they can do their own testing in China...and that these samples were provided to them...

Anybody want to guess what the Chinese will report?

At an embassy news conference in Washington, Chinese officials said the problems
linked to heparin could have occurred in the United States, or that chronic
conditions in some patients led to severe reactions.

This is not the statement of a scientific team focussed on identifying the root cause of an adverse event...which is a demanding, difficult task which requires good research, scientific judgement and caution...these things need to be right...

No, this is the type of waffling statement made by organizations trying to duck out on their responsibility...they will say anything in order to shift the blame or to avoid being held accountable...exactly the sort of behavior that can not possibly result in identifying and correcting the current problem...

FDA suspects heparin contamination due to fraud

2008-04-17T15:07:00.000-04:00

The US Food and Drug Administration (FDA) believes that the contamination of Baxter's blood thinner heparin, which has been linked to 62 deaths in the US, may have been due to the deliberate replacement of some ingredients with cheaper alternatives.

Analysis by the agency recently established that the drug lots in question contained oversulfated chondroitin sulphate, which is a less-expensive, animal cartilage-derived alternative to raw heparin that is not approved for use in medicine. Oversulfated chondroitin sulphate has been implicated in causing the hypersensitivity reactions associated with contaminated heparin.

FDA Commissioner Andrew von Eschenbach told the US Senate on Tuesday that the agency suspected the ingredient switch had been made "by virtue of economic fraud," but added that it would leave further investigation of the matter to Chinese State Food and Drug Administration officials.

link to full article

Lung cancer warning a death knell for inhaled insulin?

2008-04-10T13:26:00.000-04:00

You know all those jokes about drugs where the side effectes are worse than the symptoms the product is supposed to help with?

Pfizer has updated the US product labeling of its inhaled insulin treatment Exubera to include a warning of increased risk of lung cancer among those using it.

Warning labels were issued as a consequence of a clinical trial in which 6 of the 4,740 Exubera-treated patients developed lung cancer, as opposed to 1 of the 4,292 patients not treated with Exubera.

The move is the latest twist in the downwards spiral of Exubera, which appears to have taken the whole inhaled insulin market down with it.

Exubera launched as the world's first inhalable insulin and was touted as a potential $2bn a year blockbuster. However, it was dogged by safety concerns, as well as complaints that the device was too expensive and cumbersome, leading to Pfizer abandoning the treatment.

link to full article

Alligator blood may put the bite on antibiotic-resistant infections

2008-04-08T10:02:00.000-04:00

Who comes up with this stuff?...

NEW ORLEANS, April 6, 2008 — Despite their reputation for deadly attacks on humans and pets, alligators are wiggling their way toward a new role as potential lifesavers in medicine, biochemists in Louisiana reported today at the 235th national meeting of the American Chemical Society. They described how proteins in gator blood may provide a source of powerful new antibiotics to help fight infections associated with diabetic ulcers, severe burns, and “superbugs” that are resistant to conventional medication.

Their study, described as the first to explore the antimicrobial activity of alligator blood in detail, found a range of other promising uses for the gator’s antibiotic proteins. Among them: combating Candida albicans yeast infections, which are a serious problem in AIDS patients and transplant recipients, who have weakened immune systems, the scientists say.

“We’re very excited about the potential of these alligator blood proteins as both antibacterial and antifungal agents,” says study co-author Mark Merchant, Ph.D., a biochemist at McNeese State University in Lake Charles, La. “There’s a real possibility that you could be treated with an alligator blood product one day.”

link to full article

Technique accelerates analysis for 1,000 Genomes Project

2008-04-07T13:23:00.000-04:00

The 1,000 Genomes Project is to benefit from a powerful new computational tool which can analyse half a million DNA sequences within ten minutes.

The tool, which uses an innovative statistical technique to analyse genetics data faster and more accurately than previous methods, should allow scientists to detect more subtle genetic variations at a lower cost.

Over the last five years, the experimental technology used to obtain genetic sequences has massively improved. Whereas it took 13 years to obtain the first fully sequenced human genome, scientists now plan to sequence 1,000 more human genomes within the next three years, to find the subtle genetic variations between different human beings.

One of these techniques is pyrosequencing, which provides longer sequences of base pairs (250 compared to 35 with other methods). However, with these new techniques comes an enormous amount of data, so scientists are continually looking for innovative new techniques to analyse the data at a higher speed and to a greater accuracy than ever before.

"We're on the edge of a real technological revolution that I think will help us understand the genetic causes of diseases in humans and how genetic materials determine traits in animals," said Gabor Marth, a member of the 1,000 Genomes Project from from Boston College in the USA. "It is going to lead to less expensive technologies that will allow researchers to decode any individual."

link to full article

link to 1,000 Genomes Project

Beijing smog may affect athletes

2008-04-06T09:07:00.001-04:00

They claim they can regulate smog...

too bad, drug manufacturing must be a little trickier...

But Chinese leaders have made repeated assurances that Beijing's notorious smog will be solved before the Olympic Games begin.

Beijing's heavy pollution may hurt the performances of athletes in this summer's Olympic Games, although it will not endanger their health, International Olympic Committee President Jacques Rogge said Saturday.

The IOC in recent months has acknowledged the possibility that athletes' performances may be affected by China's pollution. But Chinese leaders have made repeated assurances that Beijing's notorious smog will be solved before the Olympic Games begin.

"The health of the athletes is absolutely not in any danger," Rogge said Saturday. "It might be that some will have to have a slightly reduced performance, but nothing will harm the health of the athletes. The IOC will take care of that."

link to full article

US and Chinese pharmacopoeias expand working relationship

2008-04-03T13:49:00.000-04:00

I would like to think that this will help...here's hoping...

The pharmacopoeias of the US and China will work more closely together in future in a bid to improve the quality of medicines available in both countries.

To that end, the US Pharmacopoeial Convention and the Chinese Pharmacopoeia Commission have signed a memorandum of understanding (MoU), to tighten up the physical and documentary standards applied to pharmaceutical ingredients and establish processes to update existing monographs in both countries.

The deal is in response to the globalization of the pharmaceutical market, with drug firms increasingly sourcing ingredients from a wide range of territories.

Such a climate has created the need for greater cross-border collaboration on monitoring and standards. This was highlighted by recent problems with ingredients sourced in China that saw unscrupulous suppliers substitute the excipient glycerin for the toxic compound diethylene glycol (DEG). Since the case emerged, the USP has been working with the Food and Drug Administration's Pharmaceutical Ingredient Safety Taskforce to modify the identification test for glycerine, and to move DEG-specific testing from the impurity analysis section of the monograph to become part of the identity test.

link to full article

How to have smarter conversations...

2008-04-02T19:38:00.000-04:00

Marc from JNJBTW posted a comment in response to a post the other day about Centocor's new corporate blog with an interesting point about the changing state of our industry as it relates to blogging...

if we are going to really start to understand how the world is changing, we are
going to have to start to be part of the conversation.

I have been puzzling as to what form this conversation is going to take...

Can it be a thoughtful conversation? How many blogs does it take to discuss an entire industry? How far will we get before louder tries to trump smarter?

As usual, there are guidelines for "Smarter Conversations" available from Hugh...

NIH, EU move to ban “brain doping” in academia

2008-04-02T12:02:00.000-04:00

This is great...now it's not just the athlete's!!!...the World Anti-Brain Doping Agency!!!...you can't make this stuff up...

To be a cutting-edge scientist, you can’t be a dummy. Now, it would seem, you can’t be a dope.

As many readers already know, the press has been paying close attention to the question of brain-enhancing chemicals among academic researchers — specifically, the ethics of “brain doping,” using compounds that were originally designed as treatment for neurological conditions in order to enhance performance: e.g., using the anti-narcolepsy drug Provigil (modafinil) to extend hours of wakefulness, or taking the anti-hyperactivity drug Adderall (amphetamine) to boost energy levels.

Here’s a quick summary of the most prominent articles from the recent mainstream press:

The Blue Pill Makes you Smarter (NPR)
Professor’s Little Helper (Nature)
Brain-Boosting Drugs Hit the Faculty Lounge (Chronicle of Higher Education; n.b. the reader comments on the same page)
Brain Enhancement Is Wrong, Right? (New York Times)
Office Pill-Popping (Wired; this piece is not about academia but raises similar issues in the broader working world)

Now, in answer to these concerns, the NIH and its European equivalents have moved to block the use of brain-enhancing drugs among any individuals or institutions accepting federal money to fund their research. The effort is being spearheaded by a multinational agency, the World Anti-Brain Doping Agency (WABDA), which will “to help individual academic federations implement testing procedures in the fields of academic research.

link to full article

link to Ouroboros blog

Spit tests may soon replace many blood tests

2008-04-01T15:30:00.000-04:00

Not too soon for me...

Easy-access body fluid may provide less invasive diagnosis thanks to proteomics
One day soon patients may spit in a cup, instead of bracing for a needle prick, when being tested for cancer, heart disease or diabetes. A major step in that direction is the cataloguing of the “complete” salivary proteome, a set of proteins in human ductal saliva, identified by a consortium of three research teams, according to an article published today in the Journal of Proteome Research. Replacing blood draws with saliva tests promises to make disease diagnosis, as well as the tracking of treatment efficacy, less invasive and costly.

link to full article

More on the Heparin Saga

2008-03-31T15:49:00.000-04:00

Chinese quality stinks!!! Chinese drug regulation stinks!!!

"urging"...

"issued a plea"...

"safeguarding the legality, quality and safety of active pharmaceutical
ingredients (APIs)" is ultimately the responsibility of the importing
country."

These people are unbelievable...

China's drug regulatory authority is finally responding to curb its damaged reputation by urging its local authorities to take a more proactive role in stemming what is fast becoming a global heparin contamination, sparked by material sourced in the country.

According to Chinese media reports, the State Food and Drug Administration (SFDA) issued a message on its website urging its regional offices to boost their supervision of the production methods of heparin manufacturers in their locality.

The watchdog has also urged heparin producers to source their raw heparin from registered suppliers only, and issued a plea to heparin manufacturers to ensure they are producing the material in accordance with the approved standards.

In addition, the SFDA warned manufacturers that they must take the initiative to closely follow the clinical effects of their products that are on the market and if any problems are linked back to their manufacturing facilities, they must halt production immediately and recall any implicated products from the market.

Moreover, the agency told raw heparin suppliers to tighten their management and quality checks of raw and supplementary materials. The SFDA's latest actions indicate a softening of the stance on drug exports from the country that it took this time a month ago, when it effectively sent out a message to the world of "buyer beware".

link to full article

Doctors wary after cholesterol drug flop

2008-03-31T13:45:00.000-04:00

I like the carefully worded, carefully considered conclusion provided by the lead researcher...

"no result — zilch. In no subgroup, in no segment, was there any added benefit"

I guess Big Pharma wants another blockbuster...I also guess they're busted...

CHICAGO - Leading doctors urged a return to older, tried-and-true treatments for high cholesterol after hearing full results Sunday of a failed trial of Vytorin.

Millions of Americans already take the drug or one of its components, Zetia. But doctors were stunned to learn that Vytorin failed to improve heart disease even though it worked as intended to reduce three key risk factors.

"People need to turn back to statins," said Yale University cardiologist Dr. Harlan Krumholz, referring to Lipitor, Crestor and other widely used brands. "We know that statins are good drugs. We know that they reduce risks."

The study was closely watched because Zetia and Vytorin have racked up $5 billion in sales despite limited proof of benefit. Two Congressional panels launched probes into why it took drugmakers nearly two years after the study's completion to release results.

link to full article

Where to Eat

2008-03-25T20:47:00.002-04:00

Some places to eat while you're in Town...

Breakfast

Steve's Cart- corner of 17th and Ludlow- on the plaza of the old United Engineer's Building- my daughter's favorite restaurant

Tony Luke Jr's- 118 S 18th St- in between Chestnut and Sansom- grab a scrambled egg and pork roll sandwich for breakfast (with hot sauce...if you need to wake up)

Lunch- Casual

Hot Tamales- a quick bite- Mexican style

Steve's Cart- again

Hard Rock Cafe- it's louder in Philly

Dinner by yourself

Tony Luke's- a South Philly original- get a real cheesesteak!!!

Dinner with a Client

Morton's- a favorite

The Capitol Grille - right downtown

Shula's- eat a BIG steak

Tequila -very nice, worth the cab ride

McCormick and Schmick's - also nice

Relaxing

Tir Na Nog - right down the street from the Convention Center

The Irish Pub- a classic Philly spot

Something Else to do...

2008-03-25T20:39:00.000-04:00

if you're looking for something else to do in Philly...

(other than Interphex)...

We recommend the Rodin Museum located out on the Benjamin Franklin Parkway

Join us for Breakfast

2008-03-25T20:18:00.000-04:00

ISPE Joint Chapter Breakfast at Interphex

Who: Delaware Valley, New Jersey, and Great Lakes Chapters of ISPE

What: Breakfast Meeting and Presentation

Where: Philadelphia Marriott

When: 27Mar08- 7-9 am

Why: because you get up really early in the morning when you sleep in a hotel

The topic will be an Overview on Sustainable Design and LEED presented by Terry Jacobs, and How Does LEED Affect Your Project from the CM Perspective presented by Rick Warhall and Jonathan Hess of Whiting Turner.

Registration

Directions

From JNJ BTW...

2008-03-24T20:00:00.001-04:00

Check out an interesting J+J video...

"From Molecules to Medicines"

FDA Product Safety Alert for Heparin

2008-03-24T15:14:00.000-04:00

the Heparin saga continues...

Braun Heparin Sodium in 5% Dextrose and 0.9% Sodium Chloride Injection Solution

Has Biotech gone the way of Big Pharma?

2008-03-23T20:40:00.000-04:00

Think Big Pharma has problems with their pipeline?...

Check out this report recently published by Ron Rader of the Biotechnology Information Institute

The report focuses on recent approval trends for biotech products with current approval data thru 2007...and, quite frankly, the news is not good...

Ron is also publishing reports detailing industry information for the biotech market sector...

The Heparin Saga expands...

2008-03-22T20:02:00.000-04:00

B. Braun Medical issues recall of heparin

B. Braun Medical Inc. recalled heparin blood thinner in the U.S. and Canada after learning that it contained a "heparin-like contaminant" from a supplier linked to deaths and allergic reactions in another company's product.

The contaminant was supplied by Scientific Protein Laboratories, Irvine-based B. Braun Medical said Friday. Scientific Protein also supplied Baxter International Inc. with heparin containing a cheaper ingredient from China.

Baxter's heparin has been linked to serious allergic reactions and 19 U.S. deaths. The heparin recalled by Braun is sold to hospitals as a premixed solution in intravenous drip bags, a Food and Drug Administration spokeswoman said.

Neither Braun nor the FDA was aware of anyone sickened by the recalled heparin.

link to full article

Contaminant found in heparin

2008-03-19T15:59:00.000-04:00

WASHINGTON - U.S. health officials have identified a contaminant in batches of the blood thinner heparin associated with 19 deaths and are trying to determine how the chemical got into the drug.

The lots of heparin, whose key ingredient was imported from China, were recalled Feb. 28, and Food and Drug Administration officials said Wednesday that no new deaths have been reported since that time.

Dr. Janet Woodcock, head of the FDA's Center for Drug Evaluation and Research, said the contaminant is oversulfated condroitin sulfate, a chemical that does not occur naturally.

Condroitin sulfate is a natural compound that occurs widely and is used as a dietary supplement but the oversulfated version has not been widely studied.

"We cannot rule in or out whether this was accidentally or deliberately introduced into the product," Woodcock said, "We are investigating how it got in."

The FDA has also initiated testing of imported heparin entering this country and Woodcock said the agency feels "doctors and patients now can be confident that the product on the market has been tested and is safe."

link to full article

Stem-Cell Therapy in China Draws Foreign Patients

2008-03-18T15:33:00.000-04:00

Let's hope quality problems aren't happening in these circumstances...

China is gaining popularity among a new breed of travelers: patients with incurable conditions who are visiting the country to receive experimental stem-cell treatments not offered in the United States.

One company is now claiming a medical breakthrough, advertising that its treatments are restoring vision to blind children. It has ignited a firestorm of controversy in both China and in the U.S.

full story on npr

New Corporate Pharma Blog- Centocor

2008-03-17T20:38:00.003-04:00

Corporate blogs are still few and far between...especially corporate blogs in the Pharm Bio market sector...

Check out CNTO411...Centocor's corporate blog...

Even though some voices in the blogosphere are bouncing around some negative comments about corporate blogging, Centocor should be applauded for their efforts...

Will they find it difficult?...maybe

Will it be worthwhile?... it might not seem so at first

Will they drop the effort if it doesn't appear to produce observable results?...hope not

for an explanation of the purpose of corporate blogging-(and an explanation of the odd little cartoon at the top of this post...)
click here

hint- it has to do with a porous membrane

The Madness continues...

2008-03-14T14:32:00.003-04:00

Get your bracket filled out now...

the original WSJ post is here...

with some additional comments from Derek's piepline here...

Scientists simulate pandemic influenza outbreak in Chicago

2008-03-13T14:42:00.000-04:00

Blacksburg, Va. – By using computer simulations and modeling, an international group of researchers including scientists from the Virginia Bioinformatics Institute (VBI) at Virginia Tech’s Network Dynamics and Simulation Science Laboratory (NDSSL) have determined how a pandemic influenza outbreak might travel through a city similar in size to Chicago, Ill. This information helped them to determine the preferred intervention strategy to contain a potential flu pandemic, including what people should do to decrease the likelihood of disease transmission.

The new results, based on three different computer simulation models, are described in a paper published in the Proceedings of the National Academy of Sciences by scientists involved in the Models of Infectious Disease Agent Study (MIDAS).* MIDAS is a collaboration of research and informatics groups supported by the National Institutes of Health (NIH) to develop computational models to examine interactions between infectious agents and their hosts, disease spread, prediction systems, and response strategies.

The global epidemic of avian influenza in bird populations, as well as the risk of a virulent form of the bird flu virus being transferred to humans, has made influenza pandemic preparedness a top public health priority in the United States, Europe, and other countries. The great influenza pandemic of 1918 resulted in 40 to 50 million deaths worldwide. If a pandemic were to occur today, it could cause widespread social and economic disruptions.

link to full article

Finally, a reason to start drinking alcohol

2008-03-13T14:40:00.000-04:00

As if you needed one...

WASHINGTON (Reuters) - People who do not drink alcohol may finally have a reason to start -- a study published on Friday shows non-drinkers who begin taking the occasional tipple live longer and are less likely to develop heart disease.

People who started drinking in middle age were 38 percent less likely to have a heart attack or other serious heart event than abstainers -- even if they were overweight, had diabetes, high blood pressure or other heart risks, Dr. Dana King of the Medical University of South Carolina in Charleston and colleagues found.

link to full article

March Madness...

2008-03-11T14:17:00.001-04:00

It's that time of year again...only in Philly...

Interphex

March 26-28...

The Baxter Heparin Saga...pick your spin...

2008-03-06T14:46:00.000-05:00

There are a lot of different ways to look at this issue...

- Writer's Scare Tatics..."Tampering possible in China"

- Troubleshooting drug safety is scientific challenge...heparin-like molecules

- FDA and manufacturer cooperate to maintain drug supply...Earlier this month, the firm stopped production, but the FDA wanted to keep the existing Baxter heparin in doctors' hands because it did not want to cause a shortage of the life-saving drug. Agency officials said increased production by the other heparin manufacturer can now satisfy the demand.

- FDA doesn't inspect overseas manufacturing sites...The FDA has averaged just 15 inspections in China in each of the last five years

- Lack of FDA oversight on imports...Flood of drugs, little oversight by regulators

- Outsourcing causes quality problems...Baxter’s Heparin Problems May Have China Connection

- Chinese quality control...Baxter tests point to Chinese problem

- Realtime crisis management...Call to action at Baxter

Manufacturer intitiates recall...Baxter Issues Urgent Nationwide Voluntary Recall of Heparin

Before you decide on which drum you think should be beat on, just remeber that these issues are harder to solve than you might think...

Operation Jupiter rains on fake antimalarials

2008-02-28T13:29:00.000-05:00

anti-counterfeiting operations...sounds exciting...

A multinational, multidisciplinary initiative involving scientists, public health workers, police and government officials could provide a cogent model for rooting out and stamping out counterfeiting of essential and lifesaving drugs.

But replicating 'Operation Jupiter', which employed a battery of forensic tests ranging from mass spectrometry to palynology (pollen analysis) to track down a source of fake artesunate in southern China, would require technical capacity and resources as well as collaborative efforts that at present are sorely lacking in the countries most affected by counterfeiting.

In the developed countries where fake pharmaceuticals are still at a relatively low ebb, counterfeiting can infiltrate a wide range of drugs, but in particular lifestyle products such as the erectile dysfunction treatments Viagra (sildenafil citrate, Pfizer) and Cialis (tadalafil, Eli Lilly).

The focus of the operation co-ordinated by the World Heath Organization's (WHO) Western Pacific Regional Office, the International Criminal Police Organisation (INTERPOL) and the Wellcome Trust-University of Oxford South-east Asian Tropical Medicine Research Programme, in close co-operation with the Chinese authorities, was a generic medicine for a tropical disease that threatens some 40 per cent of the world's population and still claims over a million lives a year.

link to full article

FDA plans new post-approval drug safety effort

2008-02-27T15:02:00.000-05:00

A step in the right direction...Hopefully the FDA will start to knock these issues off one at a time...hopefully, the follow-through doesn't bog down in bureaucracy...

WASHINGTON (Reuters) - The U.S. Food and Drug Administration is launching a new effort meant to strengthen its oversight of prescription drugs after they win approval, an agency official said on Tuesday.

The plan, called "Safety First," includes creation of a new database of possible side effects from medicines, plus clear schedules for following up on concerns about them.

The effort was first reported by the Wall Street Journal. FDA spokesman Christopher DiFrancesco confirmed the information in the Journal's story.

The action is the FDA's latest move to address charges that the agency has been slow to respond to potential side effects that emerge after a medicine reaches the market.

link to full article

Novel genetic technique 'creates' stem cells

2008-02-26T14:01:00.000-05:00

Scientists can now transform adult cells to a stem cell-like state without using a cancer inducing gene. Researchers at Harvard University said they can now map the stages of the reprogramming which had thus far been a mystery.

"By defining cellular intermediates of the reprogramming process, our work provides reference points for understanding the molecular mechanisms underlying pluripotent (iPS) cell generation," said Dr. Matthias Stadtfeld, one of researchers on the project.

"For example, one can now take the whole reprogramming process apart into different stages and ask what enzymes or genes are important for the different stages to be initiated and completed."

The team at Harvard Stem Cell Institute and Massachusetts General Hospital have been studying the conversion of mouse adult cells to embryonic-like states by using four genes. The general way to induce iPS cells is to use cancer causing genes to initiate the process and use retroviruses to insert the genes into the target cells - retroviruses which could activate the cancer cells. The use of either oncogenes or retroviruses would make it impossible to use these cells in patients.

link to full article

Baxter unaware plant not inspected

2008-02-22T13:46:00.000-05:00

Baxter International Inc. does not monitor its supply chain to the extent that it would know that a supplier in China was never inspected before it began shipment of the blood-thinning drug heparin, which is linked to more than 300 illnesses in the U.S., the company's chief executive said Wednesday.

Baxter contracted with a Wisconsin supplier, Scientific Protein Laboratories, and not with that company's Chinese affiliate, Baxter CEO Robert Parkinson said Wednesday in his first interview since the heparin problems surfaced.

"It's not unusual for us not to know that the FDA hasn't inspected a supplier to a supplier," Parkinson said.

Deerfield-based Baxter's troubles with heparin highlight the concerns many U.S. companies and consumers have about their vulnerability to errors by suppliers from China and other less-developed countries. Problems with tainted toys, toothpaste, tires and pet food from China in the last year preceded Baxter's issues with heparin, made from an active ingredient imported from China.

link to full article

Amgen calls Roche 'snake-oil salesman'

2008-02-21T11:09:00.000-05:00

I can't wait for the response...in the headline of the Street Journal...

"and you're a big doo-doo head!!!...so there..."

No way, Roche. Amgen rejected a royalty offer from the Swiss drugmaker, which wants to sell an anemia drug that would compete against Amgen's signature blockbusters. Mircera, Roche's version, was approved by the FDA in November, but a jury ruled that the drug would infringe on Amgen's patents. Despite a juicy royalty offer of some 20 percent--twice that paid by Johnson & Johnson for its Procrit med--Amgen is holding fast.

In fact, according to court documents, the California company is scrapping for the fight. After likening Roche to a "snake-oil salesman," Amgen says in court documents, "The only thing more astonishing than Roche's false assertions of its public interests is it chutzpah now in proposing that the Court order a license at a royalty rate of 20 percent."

link to full article

FDA Says It Approved The Wrong Drug Plant

2008-02-19T15:40:00.000-05:00

and things go from bad to worse...

sometimes the last thing you want to do is find out what is really going on...'cause it might be scary to contemplate...

Heparin Probe Sends Inspectors to China

The Chinese facility that supplies the active ingredient of the widely used blood thinner heparin was never inspected by the Food and Drug Administration because the agency confused its name with another just like it, agency officials said yesterday.

The FDA said that a team of inspectors is headed now to China to inspect the plant as part of an effort to determine what may have caused a sudden spike in serious problems with the drug, which has been on the market since the 1930s.

link to full article

Congressman: FDA chief should resign

2008-02-18T14:56:00.000-05:00

Now that Congress has solved the "steriods in baseball issue", they can move on to bigger and better things...

politicizing the FDA!!!...

The heparin pile-on has begun--but this time, the FDA is at the bottom, not the drugmaker. As Baxter analyzes product samples for impurities that might have caused 350 adverse reactions, including four deaths, Congress and other critics are pointing fingers at the watchdog agency. And the FDA itself admits that yes, it violated its own procedures in approving the drug for sale without inspecting the Chinese plant where its active ingredient was made. One key Congressional critic is even asking FDA chief Andrew von Eschenbach to step down.

Baxter, of course, isn't getting off scot free. Its internal investigation is squarely under the media spotlight. So far, the company has found some differences between problem heparin vials and controls, and some of the differing samples did come from China. But so far, said a company spokeswoman, "[I]t's unclear what the impact of these differences is."

Baxter also ID'd the supplier in question, which it had refused to do before. The API maker is Scientific Protein Laboratories, a Wisconsin company that makes bulk heparin at a Chinese factory and at another at HQ. SPL says both plants adhere to the same industry and FDA safeguards. The agency is prepping an inspection team to check out the Chinese plant, and Baxter plans to send its own investigators. But plant personnel know inspectors are coming. "We'll fully cooperate," said a quality-control manager at the Chinese plant.

The big question posed by lawmakers and consumer advocates alike: With most bulk drug ingredients made overseas now--and only 7 percent of foreign plants inspected a year--what else is falling though the cracks? Some even want lawmakers to bar Chinese-made pharma ingredients. "China is fundamentally incapable of safeguarding...safety and efficacy," one business ethicist told Pharmalot.

link to full article from fiercepharma

China Plant Played Role

2008-02-14T14:45:00.000-05:00

I am glad to see that the FDA will be inspecting this facility "soon"...

I was discussing this issue with a colleague the other day...we had noted that the vials produced at the plant had tested negative for contaimination and endotoxins...with that infromation, the person I was discussing this with said something alog the lines of "Mark my words, there will be an issue with one or some of the ingredients coming from oversees..."

A Chinese facility that hasn't been inspected by the U.S. Food and Drug Administration made the active ingredient in much of the widely used Baxter International Inc. blood-thinner that is under investigation after reports of hundreds of allergic reactions and four deaths among the drug's users, the agency said yesterday.

The disclosure is likely to add to broad concerns about the safety and quality of products imported from China and elsewhere in the developing world. A tide of tainted goods ranging from pet food to children's toys has prompted recalls and increased scrutiny of Chinese-made wares around the world.

Although it isn't known whether the Chinese plant played a part in the drug's problems, its role as a supplier to Baxter is expected to fuel questions about U.S. regulators' ability to ensure the safety and quality of imported drugs and drug ingredients.

On Monday, Baxter announced that it had temporarily halted production of its version of the generic anticlotting drug heparin because of about 350 bad reactions potentially tied to the drug, including four fatalities, primarily in patients undergoing kidney dialysis and heart surgery.

Yesterday, both Baxter and the FDA said it wasn't clear that the ingredient from the Chinese supplier was tied to the bad reactions. "We honestly don't know" the cause, an FDA spokeswoman said.

link to full article

Governor visits Carlsbad to tout biotech industry

2008-02-13T13:13:00.000-05:00

biotech as job creation...one of my favorite issues...go arnold...

As the state economy sputters, Gov. Arnold Schwarzenegger was in Carlsbad yesterday to shine the spotlight on biotechnology, an industry that is growing.

“We are here today to talk about job creation,” Schwarzenegger said after touring a stem cell lab and manufacturing facilities at Invitrogen, a publicly traded biotechnology company that makes tools for drug-discovery research.
While the state's unemployment rate has climbed to 6.1 percent, biotechnology has continued to sprout and grow, he said. Invitrogen, for example, has grown 5.5 percent in the past year and is expanding its manufacturing capacity by 50,000 square feet and hiring an additional 200 workers, Schwarzenegger said.
In California, 240,000 people are employed in 5,500 life-science companies, which include those that make therapies, medical devices, diagnostics and tools. The industry attracted $3.2 billion in venture-capital investment last year, which was half the nationwide total, the governor pointed out.
And California's $3 billion investment in stem cell research, known as Proposition 71, is helping research institutes attract the best and brightest talent from around the world and fuel potentially lifesaving research, he said.
Schwarzenegger said he wanted to use his appearance at Invitrogen for a round-table discussion with the region's business leaders. Specifically, he wanted to know what state government could do to further support the health and growth of an industry that provides high-skilled and high-wage jobs and is expected to continue growing for many years.
In the San Diego area, the biotech industry returned $8.5 billion to the economy, state Labor Secretary Victoria Bradshaw said.

link to full article

FEP Update

2008-02-06T22:08:00.001-05:00

Invasion of the Document Snatchers- the Aftermath continues- The Quarterly Review

FDA looks for "boots on the ground" in China

2008-02-06T14:43:00.000-05:00

First it was India...now China...

WASHINGTON (Reuters) - The United States is hoping to bolster the safety of food and other products imported from China by opening a new Food and Drug Administration office in the Asian nation.

"We will be able to continue to expand our own ability to leverage, beyond simply sending inspectors over, but to have people in place," FDA Commissioner Andrew von Eschenbach said during the Reuters Regulatory Summit here.

"We're boots on the ground," he said.

FDA officials see the office, which must be approved by the Chinese government and funded by Congress, as a model for outposts elsewhere, which in an era of globalized trade would shift much of the burden for safe imports to producer countries instead of relying on inspections at home.
Von Eschenbach said FDA officials in China, rather than regularly patrolling factories, would seek to create more stringent safety standards among producers and would look to strengthen regulation by Chinese government.

Basing officials in China would also allow the FDA to move quickly when problems do arise, rather than having to secure visas or make long trips before setting off to inspect problem facilities.

link to full article

US FDA budget seeks biotech generics, user fees

2008-02-05T11:13:00.000-05:00

People are starting to talk about the impact of the political system on the FDA...

Not good to see this function impacted by politics...

WASHINGTON, Feb 4 (Reuters) - New fees for the Food and Drug Administration to speed review of generic pharmaceuticals and new authority to approve copycat versions of some biotech drugs were proposed in President George W. Bush's budget on Monday.
The White House requested an FDA budget of $2.4 billion for the 2009 fiscal year starting in October, a 5.7 percent increase over last year's budget.

The proposal comes as the FDA faces heightened criticism for inadequate staffing, lax oversight of drug and food safety and out-of-date technology. Last week, lawmakers met to discuss a report by an independent board that concluded lives are at risk because the agency is so underfunded and behind in cutting edge science.

"It's pretty disappointing, especially in light of the overall unanimity of concern over food safety and drug safety," said Bill Hubbard, an advisor to the Alliance for a Stronger FDA, and former associate FDA commissioner from the early 1990s through 2005. The Alliance is made up of industry, and consumers and patient groups.

Hubbard said that because FDA's costs are more aligned with medical costs, which are rising faster than overall consumer inflation, "it's barely half of what FDA needs just to keep pace with inflation."

link to full article

New Alzheimer's theory gains NASA backing

2008-01-31T10:48:00.000-05:00

More cool stuff from NASA...I didn't know they did this kind of research...

A controversial new theory on the origins of Alzheimer's has divided opinion in the medical world, but if proved right could 'revolutionise' treatment.

Dr Shaohua Xu of Florida's Space Life Sciences Laboratory at Kennedy Space Center (KSC) and of Florida Tech has earned a $150,000 grant from Space Florida and a $30,000 cash injection from NASA's Aerospace Medicine and Occupational Health Branch to test his theory.

Conventional wisdom dictates that when tau protein joins together to form tangled fibres at the start of Alzheimer's, each tau molecule join to the fibre's tip. However, Xu has a different idea."

We find that it is a three-step process," he said. "First, molecules of the tau protein cluster together into spheres, each almost the same size. Next, the spheres join together in linear chains like beads on a string. In the third stage the beads merge together to form a uniform filament identical to those found in the brains of patients with the disease."

Using atomic force microscopy, Xu has been using purified protein to synthesis the fibres into their various forms. He first developed his theory over a decade ago. "

Shaohua's theory is revolutionary; his evidence is overwhelming. The medical implications are beyond anything in my experience," said advocate Dr Daniel Woodard at KSC, who was the first medical doctor to review Xu's work."

This could be the most important biomedical discovery ever made at Kennedy Space Center," echoed NASA physician David Tipton, chief of the Aerospace Medicine and Environmental Health Branch at KSC.

link to full article

Pot Vending Machines in LA

2008-01-31T10:35:00.000-05:00

Now all we need to do is worry about the cancer cases...

LOS ANGELES (AP) — The city that popularized the fast food drive-thru has a new innovation: 24-hour medical marijuana vending machines.
Patients suffering from chronic pain, loss of appetite and other ailments that marijuana is said to alleviate can get their pot with a dose of convenience at the Herbal Nutrition Center, where a large machine will dole out the drug around the clock.
"Convenient access, lower prices, safety, anonymity," inventor and owner Vincent Mehdizadeh said, extolling the benefits of the machine.
But federal drug agents say the invention may need unplugging.
"Somebody owns (it), it's on a property and somebody fills it," said DEA Special Agent Jose Martinez. "Once we find out where it's at, we'll look into it and see if they're violating laws."
At least three dispensaries in the city, including two belonging to Mehdizadeh, have installed vending machines to distribute the drug to people who carry cards authorizing marijuana use.
Mehdizadeh said he spent seven months to develop and patent the black, armored box, which he calls the "PVM," or prescription vending machine.
A sliding fence protects the tinted windows of his dispensary, barely distinguishing it from a busy thoroughfare of strip malls, automobile dealers and furniture shops. A box resembling a large refrigerator stands inside the nearly empty shop, near a few shelves stocked with vitamins and herbs.
A guard in a black T-shirt emblazoned with the word "Security" on the front stands at the door. A poster of Bob Marley decorates a back room.
The computerized machine requires fingerprint identification and a prepaid card with a magnetic stripe. Once the card and fingerprint are verified, a bright green envelope with the pot drops down a slot.

link to full article

5 Cool Things You Can Do With Your DNA

2008-01-30T14:45:00.000-05:00

5 Cool Things You Can Do With Your DNA