EMEA issues host of decisions

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