Friday, February 27, 2009

Amgen Statement on the Announcement of Governor Gary Locke as Commerce Secretary-Designate

Governor Gary Locke, as President Obama’s nominee for Commerce Secretary, will bring to his new position, when confirmed, a sense of urgency about the economy and the central role private sector growth will play in our economic recovery. While Governor, Gary Locke consistently pursued measures that advanced human health, fostered the development of new medicines, and helped to grow the life science and biotechnology industry in the State of Washington.

 

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Posted in Company Statements

Wednesday, February 18, 2009

FDA Accepts Amgen's Submission and Files Biologics License Application for Denosumab

THOUSAND OAKS, Calif. – Feb. 18 – Amgen Inc. (Nasdaq: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted Amgen’s submission and filed a Biologics License Application (BLA) for denosumab, an investigational RANK Ligand inhibitor. The indications for which Amgen is seeking FDA approval are treatment and prevention of postmenopausal osteoporosis (PMO) in women and treatment and prevention of bone loss in patients undergoing hormone ablation therapy for either prostate or breast cancer.

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Posted in Press Releases, Pipeline News

Wednesday, February 11, 2009

Independent Data Monitoring Committee Recommends Resuming Enrollment of Non-Squamous NSCLC Patients in the Motesanib MONET1 Trial

THOUSAND OAKS, Calif. and CAMBRIDGE, Mass., Feb. 11 and OSAKA, Japan – Feb. 12, 2009 – Amgen (Nasdaq: AMGN), Millennium: The Takeda Oncology Company, and its parent company Takeda Pharmaceutical Company Limited (TSE:4052) today announced the Independent Data Monitoring Committee (DMC) for the MONET1 trial has recommended the trial resume enrollment of patients with non-squamous non-small cell lung cancer (NSCLC) following a three-month enrollment suspension. MONET1 is a Phase 3 study evaluating motesanib (AMG 706) in combination with paclitaxel and carboplatin for the first-line treatment of advanced NSCLC. Motesanib is part of a co-development program between Amgen, Millennium and Takeda.

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Posted in Press Releases

Friday, February 06, 2009

Nplate(R) Approved in the European Union for the Treatment of Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

First and Only Approved Platelet Producer in Europe Represents New Treatment Approach for Serious Chronic Autoimmune Disorder

ZUG, Switzerland – Feb. 6 – Amgen (Nasdaq: AMGN) today announced that the European Commission (EC) has granted marketing authorisation for Nplate(R) (romiplostim) for the treatment of splenectomised adult chronic immune (idiopathic) thrombocytopenic purpura (ITP) patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). Nplate may be considered as second line treatment for adult non-splenectomised ITP patients where surgery is contra-indicated.

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Posted in Press Releases, Product News