Tuesday, June 24, 2008

New clue to Alzheimer's found in brain protein

It has been known for a while that the brains of people with the memory-robbing form of dementia are cluttered with a plaque made up of beta-amyloid, a sticky protein that accumulates in the neurons of the brain.

The big question, however, was whether this is a significant cause of the disease or a side effect.

Other suspects included tangles of a protein called tau; some scientists thought this was the cause.

Researchers at Harvard Medical School have begun to address these issues and look at what caused Alzheimer's symptoms in rats by injecting them with one particular form of beta-amyloid. Injections with two other forms of beta-amyloid did not cause dementia, which may explain why some people have beta-amyloid in their brains but do not show disease symptoms.

The injected rats had impaired memory function, especially for newly learned behaviors. When the mouse brains were inspected, the density brain cells was reduced by 47 percent with the beta-amyloid seeming to affect synapses, the connections between cells that are essential for communication between them.

If the results are confirmed in humans, they this discovery may lead to interesting new therapies to either remove, reduce or prevent the build-up of the particular form of beta-amylin that causes dementia.

News coverage from CNN

Merck buys theatre advertising for cancer vaccine ads

Has anyone seen the ads in US cinemas for Gardasil?

Apparently, Merck purchased ad time from May 30th through June 26th. The commercial will run during the trailers before SATC but also at screenings of The Incredible Hulk, Get Smart, The Happening and You Don't Mess with the Zohan among others. They're all films that will potentially attract the 19 to 26-year-old females, the likely target for the vaccine shots.

Merck is also hoping the Food and Drug Administration will soon approve Gardasil for women into their 40s, so perhaps the SATC campaign is also intended for them?

The company plans to file for the FDA approval of Gardasil for young men and boys who can carry and transmit HPV. Given the selection of summer movies Merck's marketers have made, I suspect the commercials are an attempt to raise awareness among guys as well.

Interesting approach.

Meanwhile, GSK are winning the battle for Europe, snapping up the tenders with it's cervical cancer vaccine, Cervarix. Unfortunately, Cervarix doesn't protect against genital warts although Gardasil does.

Tuesday, June 17, 2008

FDA and EMEA to Consider Additional Test Results When Assessing New Drug Safety

In the first use of a framework allowing submission of a single application to the two agencies, the Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) worked together to allow drug companies to submit the results of seven new tests that evaluate kidney damage during animal studies of new drugs. The tests measure the levels of seven key proteins or "biomarkers" found in urine that can provide additional information about drug-induced damage to kidney cells, also known as renal toxicity.

The new biomarkers include KIM-1, Albumin, Total Protein, β2-microglobulin, Cystatin C, Clusterin, and Trefoil Factor-3. Both FDA and EMEA have long required drug companies to submit the results of two blood tests, called blood urea nitrogen (BUN) and serum creatinine, to evaluate renal toxicity. In addition to those tests, the FDA and EMEA will now consider results from the seven new tests as part of their respective drug review processes. A decision by the sponsor to collect information using the new tests is voluntary, if collected, it must be submitted to FDA.

Such human tests could one day open the door to the approval of more powerful drugs, especially for diseases where renal toxicity currently prevents promising experimental drugs from being approved. With more sensitive tests for renal toxicity, FDA could approve such drugs because health care professionals could closely monitor patients and halt the drug if early signs of renal toxicity appear.

Development of the new biomarkers was led by the Predictive Safety Testing Consortium (PSTC), whose members include scientists from 16 pharmaceutical companies. The PSTC was organized and led by the Critical Path Institute, a nonprofit organization that works to support FDA research collaborations that improve the development of medical products.

Researchers from Merck and Novartis AG identified the new biomarkers, tested them to prove their accuracy and usefulness, and then shared their findings with the other consortium members for further study. The consortium subsequently submitted applications for use of the biomarkers to FDA and EMEA.

The project is the first in which a group of drug companies has worked together to propose and qualify new safety tests and then present them jointly to the FDA and EMEA for consideration. The FDA and EMEA laid the groundwork for these specific joint-agency biomarker reviews in 2004 when they developed a framework called the Voluntary Exploratory Data Submission review process.

The new process allowed the PSTC to submit a single biomarker data application to both regulatory agencies, and then to meet jointly with scientists from both agencies to discuss it in detail and to address additional scientific questions posed by the regulators. Each regulatory agency then reviewed the application separately and made independent decisions on use of the new biomarkers.
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Thursday, June 12, 2008

Big pharma and innovation

The next few years are likely to be tough for the pharma industry with a number of blockbusters going off patent and pipelines looking thinner than usual across the board. Companies are looking at ways of driving the innovation process.

The FT reported that Patrick Vallance, the head of drug discovery at GlaxoSmithKline, saying research at the company would be reorganized to become 'more biotech-like' in efforts to stimulate innovation. The plan was to split drug discovery into small units focused on specific disease areas, reward people based on successful 'value creation', while providing 'disincentives' against destroying value.

Meanwhile, Pfizer and the University of California, San Francisco (UCSF), announced a partnership in which the company will contribute $9.5 million to early-stage research at the university over the next three years.

Usually, industry funding targets specific projects, but in this case, researchers at the UCSF's Institute for Quantitative Biosciences will collaborate more broadly with the company, with both parties working together to identify promising ideas in different health disciplines. The academic researchers and their institution will retain patents to any inventions, while Pfizer will have the right to negotiate licenses on the technology.

Wednesday, June 4, 2008