European Commission Approval for biosimilar epoetin alfa
Sandoz has become the first company to develop and receive European Commission approval for its biosimilar epoetin alfa, achieving another important milestone in its efforts to bring high quality, cost-effective biological medicines to patients. The European Commission's decision to grant this approval followed a positive opinion in June from the European Medicines Agency's Committee on Medicinal Products for Human Use (CHMP), which reviews medicines scientifically for the Commission.
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Results Were Consistent in Patients Switched to Angiox from Other Antithrombin Therapy
Patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI), or angioplasty, experienced nearly 50 percent less bleeding at 30 days and comparable mortality at one-year when treated with Angiox(R) (bivalirudin) alone compared to unfractionated heparin or enoxaparin plus a glycoprotein IIb/IIIa inhibitor (GPI), according to data from the ACUITY trial.
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Award for Bilobil in Poland
The first place in the national competition "Consumer's Laurel 2007" in the category "Drugs for memory improvement" has been won by Krka's Bilobil. As in the last year, also this year Bilobil won the first place in its category.
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Recommendation of Approval for the Merz Botulinum Neurotoxin Typ A in European Countries
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) in London recommended the approval of the Merz- developed product Botulinum neurotoxin Type A. Merz is expecting approval in ten European countries within the next few months. The company already received approval in Denmark and Sweden.
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The U.S. Launch of Neupro® for the Treatment of Early-Stage Parkinson's Disease
UCB and SCHWARZ PHARMA announced today that Neupro® (Rotigotine Transdermal System), a new once-daily transdermal dopamine agonist approved for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease, is now commercially available in retail pharmacies throughout the United States. Neupro® will be co-promoted by UCB and SCHWARZ PHARMA. These companies have dedicated sales forces that will immediately begin reaching out to physicians who treat Parkinson's disease nationwide.
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Patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI), or angioplasty, experienced nearly 50 percent less bleeding at 30 days and comparable mortality at one-year when treated with Angiox(R) (bivalirudin) alone compared to unfractionated heparin or enoxaparin plus a glycoprotein IIb/IIIa inhibitor (GPI), according to data from the ACUITY trial.