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Genentech and Roche Holding AG’s biologic drug

JAMA: Avastin + Chemo May Raise Blood Clots Risk in Veins by a Third

11/19/2008

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A meta-analysis published by the Journal of the American Medical Association (JAMA), showed that Avastin ( bevacizumab), a genetically engineered immune system molecule that targets vascular endothelial growth factor or VEGF, marketed by Genentech and Roche Holding AG, raises the risk of blood clots in the veins by a third when added to chemotherapy. The Avastin label already carries a warning about blood clots in the arteries, which could break loose, travel through the arteries and cause strokes and heart attacks.

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Advanced Kidney Cancer: FDA Requests More Data on Novartis AG’s Afinitor (everolimus)

11/19/2008

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The U.S. Food and Drug Administration asked more data on Novartis AG’s advanced kidney cancer treatment Afinitor (everolimus or RAD 001), delaying its approval –according to the Swiss company- by three months. No additional studies were requested.

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Novartis AG Updates its Pipeline: Biological Drugs Represent Some 25 Percent

11/19/2008

Novartis AG said biological drugs represent some 25 percent of the exploratory pipeline, as their product portfolio increased 40 percent since 2005. The company revealed that it has a total of 139 compounds in clinical trials. Further details.

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Eli Lilly Sues Generic Drugmakers to Protect Cymbalta’s Patent

11/19/2008

Indianapolis-based drug maker Eli Lilly & Co. sued Cobalt Laboratories Inc., Impax Laboratories Inc., Sandoz Inc. and Wockhardt Ltd., after the companies filed abbreviated new drug applications to sell duloxetine, the active ingredient of the anti-depressant Cymbalta. The blockbuster drug patent expires in 2013.

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Teva: FDA Approves Generic Pulmicort Respules

11/19/2008

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Anglo Swedish drug maker AstraZeneca Plc said that Teva Pharmaceutical Industries Ltd. has been granted approval by the Food and Drug Administration for a generic version of its asthma medication Pulmicort. AstraZeneca has brought a patent infringement case against Teva.

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Merck & Co. experimental drug

MK 677 Fails to Improve Memory Skills in Alzheimer’s Patients

11/18/2008

MK 677 Fails to Improve Memory Skills in Alzheimer’s Patients In a sample of 416 individuals with mild to moderate forms of the disease, Merck & Co. investigational compound MK-677, a drug that raises levels of a natural growth hormone, failed to improve memory skills in people with mild to moderate Alzheimer's disease. The findings were published in the Neurology journal.

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Genentech Issues Dear Healthcare Provider Letter Regarding a Second Case of PML in a Raptiva Patient

11/18/2008

Genentech Issues Dear Healthcare Provider Letter Regarding a Second Case of PML in a Raptiva Patient U.S. Biotech Genentech Inc informed of a second fatal case of a rare brain infection known as progressive multifocal leukoencephalopathy (PML), on a patient taking Raptiva (efalizumab). Last October, Genentech alerted doctors and patients about a detected case of a 70 years old patient who had used the biological Raptiva for four years.

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Shire Plc Bets to Double Sales on Rare Diseases’ Drugs

11/18/2008

Shire Plc Bets to Double Sales on Rare Diseases’ Drugs Third biggest British drug maker, Shire Plc, said that one of the main goals on the long-term it’s to double their sales on biological drugs for rare diseases. Therefore, Shire aims to strongly compete against Genzyme and BioMarin.

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