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01. Amgen Names Jim Daly, Senior Vice President, North America Commercial ...

THOUSAND OAKS, Calif. -- Amgen Inc. (NASDAQ:AMGN), the world's largest biotechnology company, today announced the appointment of Jim Daly to the new position of senior vice president, North America Commercial Operations. Daly, formerly vice president and general ...

02. Amgen Submits Biologics License Application for FDA Approval of ......

THOUSAND OAKS, Calif. -- Amgen Inc. (Nasdaq:AMGN), the world's largest biotechnology company, today announced submission of a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for palifermin, a first-in-class investigational compoun...

03. European Commission Approves Kepivance(TM) (Palifermin) for Oral ......

THOUSAND OAKS, Calif. -- Amgen (Nasdaq:AMGN), the world's largest biotechnology company, today announced that Kepivance(TM) (palifermin) has received regulatory approval in the European Union (EU). Palifermin is now authorized in the EU to decrease the incidence, dur...

04. Amgen submits Biologics License Application with FDA for approval of ....

Amgen, Thousand Oaks, CA, announced it has submitted a Biologics License Application (BLA) with the US Food and Drug Administration (FDA) for palifermin, a first-in-class investigational compound in development for oral mucositis (mouth sores). The company says ...

05. Continuous Marketing Applications: Experiences of Three Biotechnology ...

INTRODUCTIONThe Prescription Drug User Fee Act (PDUFA) was reauthorized for a second time on June 12, 2002, as PDUFA 3 (1). A nonlegislative companion document, known as the goals letter, details the program and the metrics associated with the fiscal years (October 1 ...

06. STUDY BOOSTS AMGEN ANEMIA DRUG. - Free Online Library

Byline: Evan Pondel Staff Writer THOUSAND OAKS - Amgen Inc.'s anemia achrestic anemia  any of various types of megaloblastic anemia resembling pernicious anemia but unresponsive to therapy with vitamin B12. aplastic anemia  a diverse group of anemias characterized...

07. Amgen and Biovitrum sign metobolic disease license agreement. - Free ....

Amgen, Inc. (Thousand Oaks, CA) and Biovitrum AB (Stockholm, Sweden) have signed a multifaceted agreement under which Amgen receives exclusive rights to develop and commercialize Biovitrum's small molecule 11betaHSD1 enzyme inhibitors for the treatment of metabol...

08. Amgen receives FDA approval for treatment of severe organ mucositis in...

Amgen, Thousand Oaks, CA, announced the FDA has approved Kepivance (palifermin), the first and only therapy to decrease the incidence and duration of severe oral mucositis in patients with hematologic cancers undergoing high-dose chemotherapy, with or without rad...

09. Palifermin reduces incidence and duration of severe mucositis | Journa...

The FDA approved palifermin (Kepivance, made by Amgen, Inc.) for the treatment of severe oral mucositis in patients with hematologic malignancies undergoing chemotherapy with or without radiation. It is the first drug to be FDA-approved for this indication. Palifermin...

10. Amgen's Kepivance approved by FDA for severe oral mucositis in cancer ...

Amgen, Inc., Thousand Oaks, CA, announced the US Food and Drug Administration (FDA) has approved Kepivance (palifermin), the first and only therapy to decrease the incidence and duration of severe oral mucositis (mouth sores) in patients with hematologic cancers under...

11. New drug to treat cancer-related mouth sores | FDA Consumer | Find ......

Painful sores and ulcers in the lining of the mouth are a common complication of the high-dose chemotherapy and radiation therapy regimens associated with bone marrow transplants. Patients suffering from the complication, called mucositis, have difficulty eating and s...

12. New drug to treat cancer-related mouth sores | FDA Consumer | Find ......

Painful sores and ulcers in the lining of the mouth are a common complication of the high-dose chemotherapy and radiation therapy regimens associated with bone marrow transplants. Patients suffering from the complication, called mucositis, have difficulty eating and s...