FDA Accepts NDA Filing for Cleviprex(TM) for the Treatment of Acute Hypertension
- Details
- Category: Product
The Medicines Company (NASDAQ: MDCO) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's new drug application (NDA) for Cleviprex(TM) (clevidipine butyrate injectable emulsion) for the treatment of acute hypertension. If approved, Cleviprex will be the first new treatment for acute hypertension in more than 10 years.
Merck & Co., Inc. Announces Completion of NovaCardia, Inc. Acquisition
- Details
- Category: Merck
Merck & Co., Inc. announced that it has successfully completed the acquisition of NovaCardia, Inc., a privately held clinical-stage pharmaceutical company focused on cardiovascular disease. This acquisition adds rolofylline (KW-3902), NovaCardia's investigational Phase III compound for acute heart failure to Merck's pipeline.
FDA Advisory Committees Recommend Continued US Marketing Authorization for Trasylol
- Details
- Category: Bayer
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.
Sanofi-aventis Announces Settlement of Average Wholesale Price Civil Suits
- Details
- Category: Sanofi
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).
Global Phase III Trial to Evaluate Sunitinib Malate Combined with Erlotinib
- Details
- Category: Pfizer
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.
ERBITUX® Meets Primary Endpoint of Increasing Survival in Phase III Lung Cancer Study
- Details
- Category: Bristol-Myers Squibb
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).
PLIVA Enters Oncology Business in Germany
- Details
- Category: Financial
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.
More Pharma News ...
- Novo Nordisk is Rated Supersector Leader in the 2007 Dow Jones Sustainability Indexes
- Dow Jones Sustainability Index Again Recognizes Abbott
- Avastin approved in Europe for first-line treatment of patients with advanced lung cancer
- CeNeS and ERGOMED Report Start of Recruitment for Phase II trial of CNS 5161 in cancer pain
- AstraZeneca and Pozen To Start Phase III Trials With PN400
- Bayer intends to delist from the New York Stock Exchange
- Novartis to defend its intellectual property rights for Famvir®