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EMEA issues host of decisions

July 25, 2008 — 9:54am ET | By Maureen Martino

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The EMEA's Committee for Medicinal Products for Human Use (CHMP) has been busy. The drug regulator released a host of decisions today, so here's the round-up:

The Committee for Medicinal Products in Human Use (CHMP) recommended approval of Bayer's blood-thinning pill Xarelto. The drugs, which Bayer hopes will generate €2 billion in sales, prevents thrombosis in patients bedridden after major orthopaedic surgery. Report
Sanofi-Aventis' Taxotere got shot down, as the agency recommended against using the drug to treat HER2 positive breast cancer. Report
The EMEA restricting the use of antibiotics based on moxifloxacin--marketed by Bayer under the name Avelox--because of the potential risk of liver damage, and also wants strengthened warnings. Report
A positive opinion was issued on marketing authorization for Ceplene for the remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia. Release
Novartis' osteoporosis drug Aclasta was recommended to treat the disease in men who are at increased risk of fractures. Release