Wednesday, December 16, 2009

Amgen Issues Statement on Update to U.S. Prescribing Information for Erythropoiesis-Stimulating Agents (ESAs)

On December 16, 2009, Amgen updated the boxed warning in the labeling information for the class of drugs known as erythropoiesis-stimulating agents (ESAs), including Aranesp® (darbepoetin alfa) and EPOGEN® (Epoetin alfa), to reflect an increased risk of stroke when ESAs are administered to chronic renal failure patients to target hemoglobin levels of 13 g/dL and above. The update was made based on results from the recently completed clinical study, TREAT (the Trial to Reduce Cardiovascular Events with Aranesp Therapy), a large, randomized, double-blind, placebo-controlled, Phase 3 pivotal study of patients with chronic kidney disease (CKD) not on dialysis, moderate anemia and type-2 diabetes. In addition, the Warnings section has been updated to include a description of TREAT and the increased risk of stroke found in the study.

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Posted in Company Statements

Friday, July 31, 2009

Amgen Statement on the House Energy & Commerce Committee’s Approval of an Amendment to Create a Biosimilars Pathway

The following statement was issued today by Amgen on the passage of the Eshoo-Inslee-Barton amendment to the House Energy & Commerce Committee’s health care reform legislation.

The strong bipartisan support in the Energy and Commerce Committee for a fair and balanced pathway for the approval of biosimilars is a win for patients. The amendment introduced by Representatives Eshoo, Inslee and Barton and overwhelmingly approved by the Committee strikes a necessary balance in allowing access to safe and effective biosimilar medicines for patients, and providing fair incentives for the discovery of new medicines for serious diseases.

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Posted in Company Statements

Wednesday, June 10, 2009

Statement in Response to FTC Report on Biosimilars

THOUSAND OAKS, Calif.–June 10, 2009–As a biotechnology pioneer committed to developing first-in-class medicines that treat serious illnesses and unmet health needs, Amgen believes that an abbreviated biosimilar approval pathway must not discourage the development of groundbreaking new treatments for serious diseases. 

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Posted in Company Statements

Friday, April 17, 2009

Amgen Introduces New Amgentrials.com

Amgen today launched the new Amgentrials.com website (http://www.amgentrials.com), an important resource for patients, physicians, and others who seek information about the company’s clinical trials.

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Posted in Company Statements

Thursday, April 02, 2009

Amgen Statement in Response to the Patent Reform Agreement Approved by the U.S. Senate Judiciary Committee

The following statement was issued by Amgen regarding a consensus agreement on patent reform legislation which was approved by the U.S Senate Judiciary Committee today:

Patients facing life-threatening diseases—such as cancer, Alzheimer’s, Parkinson’s, and ALS— depend on the discovery and development of breakthrough treatments and cures. Strong and enforceable patents are essential in providing scientists and researchers the incentive to innovate in such a resource intensive field.

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Posted in Company Statements