Federal Court of Appeal in Canada Upholds Lipitor Enantiomer Patent
Pfizer Inc said today that the Federal Court of Appeal of Canada has reversed a lower court ruling that held that Pfizer's enantiomer patent could not block generic manufacturer Ranbaxy Laboratories Limited from obtaining approval for a competitor product to Lipitor. The appellate court issued an order prohibiting regulatory approval of Ranbaxy's product in Canada until Pfizer's enantiomer (calcium salt) patent - Canadian Patent No. 2,021,546 - expires in July 2010. 
Bayer Schering Pharma AG has received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) recommending Zevalin® ([90Y]-ibritumomab tiuxetan) as consolidation therapy after remission induction in previously untreated patients with follicular lymphoma (FL) in Europe. 
Genzyme Corp. (Nasdaq: GENZ) announced the withdrawal of the European application to extend the Evoltra® (clofarabine) product label to include the treatment of elderly patients with acute myeloid leukemia (AML). This application and the data on which it was based were filed by Bioenvision, Ltd. before the company was acquired by Genzyme last year. 
GlaxoSmithKline (GSK) notes the conclusions announced by the Medicines and Healthcare products Regulatory Agency (MHRA) regarding its investigation into disclosure of paediatric trial data for the anti-depressant medicine Seroxat (paroxetine). 
Data published in The Lancet from ABSORB, the world's first clinical trial of a fully bioabsorbable drug eluting stent for the treatment of coronary artery disease, demonstrated no stent thrombosis, no clinically driven target lesion revascularizations (retreatment of a diseased lesion), and a low (3.3 percent) rate of major adverse cardiac events (MACE) in 30 patients out to one year. 
AstraZeneca announced a trial date has been set for patent litigation in the US District Court for the District of New Jersey against Teva Pharmaceutical Industries Ltd. and Sandoz, Inc. alleging infringement of AstraZeneca's patent as a result of Teva's and Sandoz's filings of Abbreviated New Drug Applications (ANDAs). 
Women may reduce the risk of their breast cancer returning by starting treatment with Femara® (letrozole) anywhere from one to seven years after finishing tamoxifen therapy, according to a new analysis published today in the Journal of Clinical Oncology[1]. 