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A new experimental product, SGN-35, which is manufactured by Seattle Genetics Inc. and Takeda Pharmaceutical Co., combines a tumor-killing chemical, with a cancer-killing antibody. The new medication cleared cancer to untraceable levels in 53% of patients suffering from anaplastic large cell lymphoma and cut tumor size by at least half in an additional 33%.

Anaplastic large cell lymphoma is a rare type of non-Hodgkin lymphoma where a tumor develops in lymph tissue or various organs, and usually contains many white blood cells. This type of lymphoma only affects approximately 600 to 700 patients per year. Symptoms include swollen lymph nodes, neck lumps, night sweats, and extreme fatigue.

According to Bloomberg, "SGN-35 works by using an antibody to bond with a protein found on the surface of lymphoma cells, and blasts them with auristatin, a chemical that kills cancer by blocking cell division."

 

In a recent study presented at an American Society of Hematology meeting, Carfilzomib, an experimental drug manufactured by Onyx Pharmaceuticals Inc., has been found to reduce cancer in a third of patients with Myeloma. Myeloma is a build-up of cancerous plasma cells, which tend to grow and multiply rapidly and cause tumors to grow in bone marrow. The exact cause of Myeloma is unknown, but is attributed to genetic abnormalities, exposure to petrochemicals, large doses of radiation, and immune system dysfunction. Symptoms include osteoporosis at an unusually young age, kidney problems, and a low red and white blood cell count.

The study included 266 patients total who had relapsed or failed to improve after being treated with medications, including Celgene Corp.’s Revlimid and Thalomid and Johnson & Johnson’s Velcade. Of these 266 patients, 257 patients reported that 24% had their cancer reduced by half, while 10% had their cancer reduced by one-fourth.

According to Bloomberg, Onyx Pharmaceuticals Inc. will use the results to seek accelerated approval for the drug from the Food and Drug Administration (FDA).

 

On December 2, 2010, Johnson & Johnson Pharmaceuticals Inc. recalled over twelve million bottles of Mylanta and thousands of packets of AlternaGel, due to complaints of an alcoholic aftertaste. The taste comes from a small amount of alcohol in the product, which the labels failed to inform consumers about.

According to Bloomberg, in both recalls the amount of alcohol is less than 1% and the companies--- Johnson & Johnson-Merck and McNeil Consumer Healthcare respectively -- say that consumers who have any of the products can continue to use them. This latest recall is one of many in 2010 for Johnson & Johnson, who has come under a great deal of scrutiny from the FDA, following their numerous Tylenol and Benadryl recalls.

 

On December 2, 2010, the Food and Drug Administration (FDA) decided not to approve epilepsy drug, Ezogabine, even though an advisory committee unanimously voted for its approval in August 2010, after July 2010 phase III trials concluded with positive results. In one of the trials, patients on a 1,200-mg daily dose of Ezogabine experienced a median 35.2% decrease in 28-day partial seizure frequency, compared with a 29.3% decrease on the 900-mg dose, a 23.4% decrease on the 600-mg dose, and a 13.1% decrease on placebo.

With the proposed trade name Potiga, Ezogabine is an anti-convulsant manufactured by GlaxoSmithKline and Valeant Pharmaceuticals for the treatment of partial epilepsies. The FDA’s response letter to the two pharmaceutical companies cited "nonclinical reasons" as the reason for disapproval. According to the FDA, "nonclinical reasons" can refer to the lack of accuracy in marketing and/or to inaccurate language. The two companies say that they hope to have their response submitted to the FDA by early 2011.

 

On December 1, 2010, a Food and Drug Administration (FDA) advisory panel is expected to decide whether to approve two drugs for the prevention of prostate cancer. Two of the drugs, Avodart and Proscar, which are manufactured by GlaxoSmithKline, are already approved for the treatment of enlarged prostates. GlaxoSmithKline states that the drugs also have the ability to lower the risk of prostate cancer by 20%.

Although the potential for a decreased risk of prostate cancer is appealing, the FDA has many vital concerns about the efficacy of the two drugs, following a manufacturer-sponsored clinical trial. Black men, who are at the highest risk for the disease, were greatly underrepresented, according to Business Week. "The applicability to African-American men is not known due to marked under-representation," the FDA's online review stated. In addition, according to the FDA, the drugs primarily prevents against tumors grow slowly. If approved, Avodart and Proscar will be the first drugs on the market for the prevention of prostate cancer.

 
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