Monday, September 29, 2008

FDA faulted for produce oversight

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

Tuesday, September 23, 2008

Rest of Sanofi's contaminated Lovenox recalled

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

Monday, September 22, 2008

China's food safety chief quits over tainted milk

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

Thursday, September 18, 2008

Australia issues first license to clone human embryos

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

Wednesday, September 17, 2008

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

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

Monday, September 15, 2008

Thursday, September 11, 2008

New GMP Regs

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

FDA publishes final rule on cGMP amendments

Tuesday, September 09, 2008

Biologists on the Verge of Creating New Form of Life

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

Monday, September 08, 2008

FDA to List Drugs Being Investigated

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

Friday, September 05, 2008

Meaningless genetic code helped form human hands

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

Tuesday, September 02, 2008

Building boom meets maturing biotechs’ needs

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