European licence for Roche HIV drug Viracept recommended for re-instatement
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- Category: Roche
Roche announced today that the European Medicines Agency's (EMEA) Committee for Human Medicinal Products (CHMP) has recommended that Viracept's marketing authorization is re-instated in Europe following its suspension earlier this summer. The Committee stated that it is satisfied with the actions taken by Roche. The positive recommendation is an important step towards lifting the suspension of the marketing authorization and will now go to the EU Commission for a final decision.
Campath® Include First-line Treatment for Leading Form of Adult Leukemia
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- Category: Bayer
Bayer Schering Pharma AG, Germany, and Genzyme Corp., USA, announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for Campath® (alemtuzumab) and granted regular approval for single-agent Campath for the treatment of B-cell chronic lymphocytic leukemia (B-CLL).
Teva Receives Positive Feedback on Second AOK Tender in Germany
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- Category: Business
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced that it has received notification from Allgemeinen Ortskrankenkassen (AOK), Germany's largest health insurance company, on the results of the most recent tender for finished dosage pharmaceutical products. Teva is very pleased to have been awarded a significant increase in the number of molecules for which it can contract to supply during 2008-2009; compared to the six products it was awarded in the first tender earlier this year.
Novo Nordisk receives approval in the EU for use of NovoRapid® in elderly people
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- Category: Novo Nordisk
Novo Nordisk today announced that the European Commission has approved the rapid-acting insulin NovoRapid® (insulin aspart) for treatment of diabetes in the elderly and in people with renal or hepatic impairment.
Long-Term Data Reinforce Safety and Efficacy Profile of Pfizer's New HIV Drug
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- Category: Pfizer
Nearly three times as many patients receiving Selzentry, in addition to an optimized background regimen, achieved undetectable levels of HIV virus compared with those receiving an optimized regimen alone, according to 48 week data presented today in late-breaking sessions at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) meeting. This newly approved CCR5 antagonist - the first new class of oral HIV medicines introduced in more than ten years - is now available throughout the U.S.
AstraZeneca launches and prices a EUR750 million debut eurobond
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- Category: AstraZeneca
AstraZeneca PLC, rated A1 (stable) by Moody's and AA- (stable) by Standard & Poor's, priced a successful debut eurobond transaction (the "Bonds") issuing a total of EUR750 million. The proceeds of the issue will be used for general corporate purposes and to repay a portion of the outstanding US commercial paper taken on in connection with the acquisition of MedImmune.
Study Results for Aclidinium Bromide, a Novel Anticholinergic
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- Category: Clinical Trials
Forest Laboratories (NYSE: FRX) announced today that single doses of inhaled aclidinium produced a significant bronchodilatory response in 17 patients with COPD according to results of a phase IIa trial presented today at the European Respiratory Society (ERS) Annual Congress in Stockholm.(1)
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- FDA Accepts NDA Filing for Cleviprex(TM) for the Treatment of Acute Hypertension
- Merck & Co., Inc. Announces Completion of NovaCardia, Inc. Acquisition
- FDA Advisory Committees Recommend Continued US Marketing Authorization for Trasylol