Monday, December 17, 2007

Dr. Fein- And Swedesboro makes three...

An interesting series of posts regarding diversion of classified drug products...

The GMP concept of "State of Control" appears to extend further through the supply chain than just manufacturing...

link to full article

drug channels blog

Thursday, December 13, 2007

China Shuts Down Leukemia Drug Maker

perhaps the Chinese understand that they need to make serious progress on this issue...

SHANGHAI, China (AP) -- China's food and drug safety agency has revoked the license of a company responsible for making tainted leukemia drugs blamed for causing leg pains and partial paralysis among dozens of patients.

State-owned Shanghai Hualian Pharmaceutical Co., a unit of China's biggest drug maker Shanghai Pharmaceutical (Group) Co., will also be fined the highest amount allowed under law and profits from the sale of the contaminated drugs will be confiscated, the State Food and Drug Administration said in a statement on its Web site seen Thursday.

Some Shanghai Hualian executives were detained by police on suspicion they deliberately withheld information about violations of production standards during the investigation, the SFDA's statement said.

A report in the state-run newspaper Shanghai Daily said the maximum fine for a breach of regulations was only $4,000.

Shanghai city government officials said they were cooperating with the SFDA in resolving the case.

Calls to Shanghai Pharmaceutical rang unanswered Thursday morning. Calls to numbers listed for Shanghai Hualian Pharmaceutical were answered with a "this number does not exist" recording.

The investigation into Shanghai Hualian Pharmaceutical was one of a slew of cases involving contaminated or bogus drugs and foods that have prompted tighter enforcement of safety regulations

link to full article

Monday, December 10, 2007

Brain 'irrelevance filter' found

this may explain a lot, especially for some people we all wonder about...

Scientists believe they have located a new brain area essential for good memory - the "irrelevance filter".

People who are good at remembering things, even with distractions, have more activity in the basal ganglia on brain scans, the Swedish team found.

The work in Nature Neuroscience could help explain why some people are better at remembering things than others.

Clinically, it could also aid the understanding of attention deficit hyperactivity disorder (ADHD).

The ability to hold information in the mind so that it is immediately accessible is known as working memory.

We use working memory all of the time - for example, when doing a simple maths calculation in our head or recalling a telephone number.

Working memory is important because it gives a mental workspace in which we can hold information whilst mentally engaged in other relevant tasks, which is crucial for learning.

Its capacity is limited and seems to vary from person to person.

These variations are not just due to having a larger or smaller memory store, but also due to differences in how effectively irrelevant items are kept out of memory, the Karolinksa Institute researchers believe.

link to full article

Tuesday, December 04, 2007

Pfizer plans more off-shoring and outsourcing

More on the off-shoring trend...previous post here

Pfizer is looking to Asia for both R&D and manufacturing outsourcing and to help it cut costs in a bid to mitigate the effects of patent expiries and competition from generic drugs.

Pfizer announced plans to increase its R&D presence in Asia at its Hong Kong investor meeting on Friday, while saying it is also look to double the amount of manufacturing outsourcing to 30 per cent.

The pharma giant has struggled in the past year and the high profile clinical trial failure of its cholesterol-lowering drug Torcetrapib has only matters worse.

Torcetrapib would have enabled Pfizer to defend the patents its cholesterol drug Lipitor (atorvastatin) that are due to expire in 2011, potentially creating a $13bn hole in the company's revenues.

In addition, Pfizer's pipeline has been criticised from many quarters, with even the company's new president of global R&D stating "I'm the first to admit [the drug pipeline] is not as rich as I'd like it to be."

To help combat this Pfizer will look to bolster its Asian R&D, targeting China, India, Japan and South Korea.

New sites in these areas would help the company bolster its share of the Asian pharmaceutical market which is predicted to grow to $200bn by 2017.

link to full article

Monday, December 03, 2007

Newly-identified exercise gene could help with depression

In case you were trying to decide whether or not to go out for that jog...

New Haven, Conn.—Boosting an exercise-related gene in the brain works as a powerful anti-depressant in mice—a finding that could lead to a new anti-depressant drug target, according to a Yale School of Medicine report in Nature Medicine.

“The VGF exercise-related gene and target for drug development could be even better than chemical antidepressants because it is already present in the brain,” said Ronald Duman, professor of psychiatry and senior author of the study.

Depression affects 16 percent of the population in the United States, at a related cost of $83 billion each year. Currently available anti-depressants help 65 percent of patients and require weeks to months before the patients experience relief.

Duman said it is known that exercise improves brain function and mental health, and provides protective benefits in the event of a brain injury or disease, but how this all happens in the brain is not well understood. He said the fact that existing medications take so long to work indicates that some neuronal adaptation or plasticity is needed.

link to full article