FDA Advisory Committees Recommend Continued US Marketing Authorization for Trasylol
Today, the Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to the U.S. Food and Drug Administration (FDA) held a meeting to discuss the risk /benefit profile of Trasylol® (aprotinin injection), a Bayer drug used in coronary artery bypass graft (CABG) surgery.
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Sanofi-aventis Announces Settlement of Average Wholesale Price Civil Suits
Sanofi-aventis announced a civil settlement with the U.S. Department of Justice to resolve "Average Wholesale Price" (AWP) lawsuits under the federal False Claims Act relating to Anzemet® involving one of its predecessor companies, Aventis Pharmaceuticals Inc. (API).
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Global Phase III Trial to Evaluate Sunitinib Malate Combined with Erlotinib
Pfizer announced the initiation of a large, global Phase III clinical trial to evaluate the efficacy and safety of sunitinib malate, in combination with erlotinib, in previously treated patients with advanced non-small cell lung cancer (NSCLC). In addition, preliminary results from a Phase II study, presented at the International Association for the Study of Lung Cancer (IASLC) World Conference in Seoul, Korea, provided information on the safety and tolerability of sunitinib in combination with erlotinib in patients with advanced NSCLC.
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ERBITUX® Meets Primary Endpoint of Increasing Survival in Phase III Lung Cancer Study
ImClone Systems Incorporated (NASDAQ: IMCL) and Bristol-Myers Squibb Company (NYSE: BMY) announced that a Phase III study of ERBITUX® (Cetuximab) in combination with platinum-based chemotherapy (vinorelbine plus cisplatin) met its primary endpoint of increasing overall survival compared with chemotherapy alone in patients with advanced non-small cell lung cancer (NSCLC).
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PLIVA Enters Oncology Business in Germany
PLIVA d.d. announced that its German subsidiary AWD.pharma GmbH & Co. KG. ("AWD") has signed an agreement to acquire O.R.C.A.pharm GmbH ("ORCApharm"), a privately owned specialty pharmaceutical company focused on the oncology market in Germany. Upon closing of the transaction, AWD will pay a fixed purchase price of EUR 21m and up to an additional EUR 13m based on the achievement of profitability milestones for 2007 and 2008.
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Novo Nordisk is Rated Supersector Leader in the 2007 Dow Jones Sustainability Indexes
Novo Nordisk ranks as best-in-class in healthcare - one of 18 global supersectors - in Dow Jones Sustainability Indexes, the world's leading indexes for sustainability-driven investment portfolios. This ranking, effective at the opening of equity markets on 24 September 2007, is a result of the latest global analysis of corporate sustainability leadership, based on a thorough analysis of companies' economic, environmental and social performance.
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Dow Jones Sustainability Index Again Recognizes Abbott
Abbott - the global health care company - was named to the Dow Jones Sustainability World Index and the Dow Jones Sustainability North America Index for the third consecutive year. This selection recognizes Abbott's continued leadership in business, environmental and social performance.
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