FDA grants fast track designation for Boehringer Ingelheim's BIBW 2992
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- Category: Boehringer Ingelheim
Boehringer Ingelheim's investigational cancer treatment BIBW 2992 has recently received a Fast Track Designation status by the FDA. Under this designation, Boehringer Ingelheim will conduct a pivotal trial programme studying BIBW 2992 in a non-small cell lung cancer (NSCLC) patient group where prior treatment with reversible EGFR inhibitors has failed.
Abbott Receives FDA Approval for SIMCOR(R) (Niaspan(R) / simvastatin)
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- Category: Abbott
Abbott received U.S. Food and Drug Administration (FDA) approval for SIMCOR(R), the first fixed-dose combination of two widely prescribed cholesterol therapies, Niaspan(R) (Abbott's proprietary niacin extended-release) and simvastatin. SIMCOR is approved for use along with diet to lower levels of elevated total cholesterol, LDL "bad" cholesterol and triglycerides, and to raise HDL "good" cholesterol in patients with complex lipid disease when treatment with simvastatin or Niaspan monotherapies are not considered adequate.
Pharmion and MethylGene Announce U.S. Orphan Drug Designation
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- Category: Product
Pharmion Corporation (Nasdaq: PHRM) and MethylGene Inc. (TSX: MYG) today announced that the U.S. Food and Drug Administration (FDA) has designated the Companies' histone deacetylase (HDAC) inhibitor, MGCD0103, as an Orphan Drug for the treatment of acute myelogenous leukemia (AML) in the United States.
AstraZeneca and Nomura Phase4 Ventures Announce Creation of New Company "Albireo"
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- Category: AstraZeneca
AstraZeneca and Nomura Phase4 Ventures today announced the signing of a deal to form Albireo, a company focused on developing new treatments for gastrointestinal (GI) disorders.
The Medicines Company Reports Full Year and Fourth Quarter 2007 Financial Results
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- Category: Financial
The Medicines Company (NASDAQ: MDCO) today announced its financial results for the full year and fourth quarter of 2007. Financial highlights for the full year of 2007:
- Net revenue increased by 20% to $257.5 million for 2007 from $214.0 million for 2006.
Genzyme Delivers Strong Fourth Quarter to Conclude Outstanding Year
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- Category: Genzyme
Genzyme Corporation (NASDAQ: GENZ) today reported financial results for the full year and fourth quarter of 2007 and provided an outlook for continued strong growth in 2008 and beyond.
First Head to Head Study Comparing CRESTOR and LIPITOR®
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- Category: AstraZeneca
AstraZeneca announced the launch of a new clinical trial, SATURN, designed to measure the impact of CRESTOR™ (rosuvastatin) 40 mg and atorvastatin (Lipitor®) 80 mg on the progression of atherosclerosis in high risk patients. SATURN will compare the effects of these two statins on the ability to decrease progression or induce regression of atherosclerosis, the main cause of cardiovascular disease, following two years of treatment in patients with coronary artery disease.
More Pharma News ...
- Bayer HealthCare Affiliate MEDRAD and Possis Medical Sign Definitive Merger Agreement
- Cleviprex(TM) Demonstrated Rapid, Precise Blood Pressure Control in High-Risk Patients
- Record operating results for Roche again in 2007
- Bristol-Myers Squibb Company Reports Financial Results for the Fourth Quarter and 2007
- Nycomed and Wyeth announce launch of an own generic version of PROTONIX®
- TransTech Pharma, Inc. Acquires Three Programs from Novo Nordisk
- Pfizer Reports Fourth-Quarter and Full-Year 2007 Results