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.
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- Biodelivery Resumes Manufacturing Onsolis
- J&J Recalls Velcade
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- New Breast Cancer Drug Approved
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- GlaxoSmithKline Promotes Drugs for Unapproved Uses
- Ex-Glaxo Lawyer Charged With Making False Statements
- Bone Drug Reduces Breast Cancer Risk
- GlaxoSmithKline Fined
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- ProAmatine Pulled From Shelves
- "Phantom" Drug Recalls
- Novartis ordered to pay $422.5 Million in fines