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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.

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 Subject :PhRMA: More than 800 Medicines and Vaccines in Clinical Trials for Can.. 2010-01-11 04:26:15 
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Subject :PhRMA: More than 800 Medicines and Vaccines in Clinical Trials for Cancer

Dear Friends,

Few things cause patients more fear and uncertainty than a cancer diagnosis. But today because of a steady stream of new and improved medicines and treatments—cancer increasingly can be managed and even beaten. America’s pharmaceutical research and biotechnology companies are responding. Pharmaceutical researchers are now working on 861 medicines for cancer. Many are high-tech weapons to fight the disease, while some involve innovative research on using existing medicines in new ways. The medicines in development—all in either clinical trials or under Food and Drug Administration review— include 122 for lung cancer, the leading cause of cancer death in the United States; 106 for breast cancer, which is expected to strike more than 180,000 American women each year; 103 for prostate cancer, which is expected to kill more than 28,000 American men each year; and 70 for colorectal cancer, the third most common cancer in both men and women in USA. Additional medicines target brain cancer, kidney cancer, leukemia, ovarian cancer, pancreatic cancer, skin cancer, and others. In addition, companies are working on medicines to improve the quality of life for cancer patients. America’s pharmaceutical research companies are working on many new cutting edge approaches to fight cancer. They include:

  • A medicine that inhibits production of a protein that may interfere with the effectiveness of chemotherapy.
  • A drug that delivers a synthetic version of a substance derived from scorpions directly to brain tumor cells.
  • A medicine designed to induce a powerful immune response to melanoma.
  • A potential first-line treatment (meaning it’s given to patients before any other treatment) and first-in-class medicine designed to target specific cancer cells and kill them, then activate the patient’s general immune system to destroy any remaining cancer cells.
  • One therapy in development uses new nanotechnology that enhances the delivery of medicine to the patient, overcoming obstacles in existing treatments.

Click here for the complete report.

Kind regards,

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Last Edited On: 2010-01-11 04:26:15 By GCP HelpDesk for the Reason
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