What Do Cancer Cells Look Like

6 Healthcare Companies With July Catalysts

The FDA was extremely busy in June approving and rejecting drugs that inevitably shook companies up and down. July is not going to be as busy, but as usual several companies will be dealt a Blackjack while others will bust out. There are actually more FDA advisory committee meetings than PDUFA dates this month; however, oftentimes news from advisory committees can be better, or worse, than a PDUFA because often the news coming out of an advisory committee is a surprise, while a PDUFA is expected.

July 14

The first FDA decision will be for Intermezzo, which is developed by Transcept Pharmaceuticals ( TSPT ). The drug has been developed for people who wake up at night and have a hard time falling back to sleep, which is a form of insomnia. Intermezzo would be the first prescription drug for this intention on the market and would be taken as a needs-only drug. Intermezzo was rejected in October 2009. Transcept had this to say about the rejection:

In the Complete Response Letter the FDA stated that it believes Transcept has submitted substantial evidence of effectiveness for the use of Intermezzo in the as-needed treatment of insomnia characterized by difficulty returning to sleep after awakening in the middle of the night. The FDA further recognized that the Intermezzo data submitted by Transcept did not indicate significant next day residual effects. However, the FDA indicated that the intended use of Intermezzo in the middle of the night represents a unique insomnia indication and dosing strategy for which safety has not been previously established.

Transcept has been working closely with the FDA to get this problem solved in order to get Intermezzo marketed. The biggest concern the FDA has with Intermezzo is the effects on driving ability for patients the following day; Transcept was able to provide a strategy to keep double-dosing from occurring. Nevertheless, driving impairment could possibly come about if the patient takes the drug within four hours of waking up.

Transcept conducted a highway safety study to show Intermezzo would not have negative effects on driving ability if the drug is accidentally taken within four hours of driving. The results of this study can be found by reading Transcept's 8-K , filed October 19, 2010. In summary, the results showed Intermezzo did cause some effect on driving, but not significant enough to make the study a failure. However, it must be noted the FDA did not give any specifications as to what level of driving impairment would be acceptable. Nevertheless, the study showed Intermezzo was far below the level that would be equal to "driving under the influence of alcohol.

Bone Cancer – Information on Bone Cancer | Online Beauty Tips

Bone Cancer – Information on Bone Cancer

Bone cancer that originates in the bone — primary bone cancer — is rare. Fewer than 2,500 Americans are diagnosed with this type of cancer each year. The condition affects more children than adults. Bone cancer is a malignant (cancerous) tumor of the bone that destroys normal bone tissue (1). Not all bone tumors are malignant. In fact, benign (noncancerous) bone tumors are more common than malignant ones. Both malignant and benign bone tumors may grow and compress healthy bone tissue, but benign tumors do not spread, do not destroy bone tissue, and are rarely a threat to life.

Most of the time when someone with cancer is told they have bone cancer, the doctor is talking about a cancer that spread there from somewhere else. This is called metastatic cancer and can be seen in people with advanced breast cancer, prostate cancer, lung cancer as well as many others. When these cancers in the bone are examined under a microscope they resemble the tissue they came from. If someone has lung cancer spread to bone, the cells of the cancer look and act like lung cancer cells, not bone cancer cells, even after they have spread from the lungs to the bones. They are treated with the same kind of treatment (chemotherapy drugs, for example) that is used for lung cancer.

Malignant tumors that begin in bone tissue are called primary bone cancer. Cancer that metastasizes (spreads) to the bones from other parts of the body, such as the breast, lung, or prostate, is called metastatic cancer, and is named for the organ or tissue in which it began. Primary bone cancer is far less common than cancer that spreads to the bones.

Bone cancer: Primary bone cancer is cancer that forms in cells of the bone. Some types of primary bone cancer are osteosarcoma, Ewing’s sarcoma, malignant fibrous histiocytoma, and chondrosarcoma. Secondary bone cancer is cancer that spreads to the bone from another part of the body (such as the prostate, breast, or lung). The most common types of primary bone tumour are osteosarcoma and Ewing’s sarcoma, both of which are most frequently diagnosed in children and young adults.

The first symptom of bone cancer is usually pain or tenderness near the cancer. Bone pain is caused by stretching of the periosteum (thick membrane that covers bone) by the cancer, or by stimulation of nerves within the bone. Bone pain may be hard to differentiate from ordinary low back pain or arthritis. Usually the pain due to bone metastasis is fairly constant, even at night. It can be worse in different positions, such as standing up, which may compress the cancer in a weight bearing bone. If pain lasts for more than a week or two, doesn’t seem to be going away, and is unlike other pain that may have been experienced, it should be evaluated by a physician.

Life: The Science of Biology

A gynecologist's second opinion, the questions and answers you need to take charge of your health

The Big Book of Self-Reliant Living, 2nd, Advice and Information on Just About Everything You Need to Know to Live on Planet Earth

Life, The Science of Biology

The Big Book of Self-Reliant Living, Advice and Information on Just About Everything You Need to Know to Live on Planet Earth