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Approvals
Multiple sclerosis pill
04-09-2010 |  15:11 hs.
German Merck KGaA said they believe the European Medicines Agency (EMEA) will approve oral pill Cladibrine, to treat multiple sclerosis by 3Q 2010. Previous tentative approval date was last Q2010.

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For patients not responding to Rituxan (rituximab)
11-03-2008 |  07:19 hs.
Cephalon Inc won U.S. health regulators´ approval to sell its chemotherapy drug Treanda for treatment of patients with a type of non-Hodgkin´s lymphoma, the company reported.

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Orphan drug Cinryze
10-14-2008 |  09:52 hs.
The U.S. health regulating agency has granted approval to Lev Pharmaceuticals Inc´s drug Cinryze, designed to prevent attacks in patients with a genetic disorder called hereditary angioedema (HAE). This is Lev Pharmaceuticals´ first drug on the market. The company was bought in July by rival ViroPharma Inc for $ 442.9 million dollars.

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Rare clotting disorder that can cause dangerous bleeding
08-22-2008 |  13:52 hs.
The Food and Drug Administration approved Nplate (romiplostim), the first product that directly stimulates the bone marrow to produce needed platelets in patients with a rare blood disorder that can lead to serious bleeding. The injectable drug helps stimulate bone marrow into producing blood platelets in patients with chronic immune thrombocytopenic purpura (ITP). The agency approved its use for patients only after other available treatments fail to help

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Drug designed to ease symptoms of this condition
08-18-2008 |  10:14 hs.
The U.S. Food and Drug Administration (FDA) has approved Xenazine, the experimental Huntington´s disease drug designed to ease the condition´s jerky, involuntary body movements. The hereditary neurological disorder has no actual cure.

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To be marketed by U.S. Celgene
04-21-2008 |  12:04 hs.
Thalidomide, which caused birth defects when it was launched as a morning sickness pill half a century ago, has been officially approved in the European Union as a treatment for multiple myeloma. U.S. drugmaker Celgene announced the European Commission has granted full marketing authorization. Further details.

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03-20-2008 |  12:43 hs.
Cephalon Inc. today announced that the U.S. Food and Drug Administration has approved Treandafor Injection for the treatment of patients with chronic lymphocytic leukemia (CLL). The drug wil be available in April 2008.

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Spectrum Pharma´s treatment for osteosarcoma
03-08-2008 |  12:24 hs.
The U.S. Food and Drug Administration has approved late Friday Spectrum Pharmaceuticals Inc´s Levoleucovorin as a treatment for osteosarcoma, a type of bone cancer.

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Orphan Drug Approved for Marketing
02-28-2008 |  09:46 hs.

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New Indication for Abbott Laboratories’ Blockbuster
02-25-2008 |  11:46 hs.
Abbott Laboratories Inc.’s arthritis drug Humira has been approved by the Food and Drug Administration (FDA) for a new indication of juvenile rheumatoid arthritis. Full story.

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Breast Cancer Treatment
02-25-2008 |  10:12 hs.
The FDA grants accelerated approval to Genentech’s blockbuster Avastin in combination with Taxol for the first-line treatment of patients with HER 2– breast cancer

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