A renowned researcher estimates that 22,000 patients could have been saved if the Food and Drug Administration removed the heart surgery drug Trasylol two years ago. Scott Pelley reports. CBSNews.com
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EUSA Pharma Out-Licenses Preclinical-Stage Human Antibody to GlaxoSmithKline
EUSA Pharma Inc ('EUSA'), a transatlantic specialty pharmaceutical company focused on oncology, pain control and critical care, today announced that it has out-licensed the exclusive world-wide rights to its preclinical-stage human anti-interleukin-6 antibody to GlaxoSmithKline (GSK) for a consideration of up to US$44 million, comprising an upfront fee and development milestones, plus royalties on future sales.
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FDA grants fast track designation for Boehringer Ingelheim's BIBW 2992
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.
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Abbott Receives FDA Approval for SIMCOR(R) (Niaspan(R) / simvastatin)
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.
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Pharmion and MethylGene Announce U.S. Orphan Drug Designation
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.
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AstraZeneca and Nomura Phase4 Ventures Announce Creation of New Company "Albireo"
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.
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The Medicines Company Reports Full Year and Fourth Quarter 2007 Financial Results
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.