Monday, June 27, 2011

Amgen Submits Application to Expand Indication for XGEVA® (Denosumab) to Prevent or Delay Spread of Prostate Cancer to the Bone

THOUSAND OAKS, Calif., June 27, 2011 /PRNewswire via COMTEX/—Amgen (NASDAQ: AMGN) today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to expand the indication for XGEVA® (denosumab) to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases. If approved, XGEVA would be the first therapy licensed to prevent or delay the spread of cancer to the bone.

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Posted in Press Releases

Friday, June 24, 2011

Notice to Investors Regarding 2011 and 2015 Guidance

THOUSAND OAKS, Calif., June 24, 2011 /PRNewswire via COMTEX/—Today, Amgen (NASDAQ: AMGN) issued the following notice to investors:

Amgen reaffirms its guidance for 2011 and 2015.

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Posted in Press Releases

Friday, June 24, 2011

Amgen Announces Modifications to U.S. Prescribing Information for Use of Erythropoiesis-Stimulating Agents in Chronic Kidney Disease

Modified Labeling Provides Different Treatment Guidance for Patients on Dialysis and Not on Dialysis

Changes to Prescribing Information Include Modification to the Boxed Warning

THOUSAND OAKS, Calif., June 24, 2011 /PRNewswire via COMTEX/—Amgen (NASDAQ: AMGN) announced today that the U.S. Food and Drug Administration (FDA) has approved modified language in the prescribing information for the use of erythropoiesis-stimulating agents (ESAs), including Aranesp® (darbepoetin alfa) and EPOGEN® (Epoetin alfa), in patients with chronic kidney disease (CKD). The modified language, including changes to the Boxed Warning, provides important new information for the treatment of patients with CKD who are on dialysis, as well as those not on dialysis, to inform prescribers and patients of safety risks that have been identified in clinical trials. In recognition of the different benefit-risk profiles of ESA therapy in patients on dialysis compared to patients not on dialysis, the modified labeling provides separate treatment guidance for these two CKD populations.

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Posted in Press Releases

Friday, June 24, 2011

Amgen Receives Positive CHMP Opinion for Vectibix® (Panitumumab) in Combination With Chemotherapy

THOUSAND OAKS, Calif., June 24, 2011 /PRNewswire via COMTEX/—Amgen (NASDAQ: AMGN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that Vectibix® (panitumumab) be approved for use in the European Union (EU) in first-line in combination with FOLFOX and in second-line in combination with FOLFIRI in patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) for patients with wild-type KRAS metastatic colorectal cancer (mCRC), following a successful re-examination procedure by Amgen.

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Posted in Press Releases

Tuesday, June 21, 2011

Teachers and Schools Across North America Receive $10,000 Amgen Award for Science Teaching Excellence

THOUSAND OAKS, Calif., June 21, 2011 /PRNewswire via COMTEX/—Amgen (NASDAQ: AMGN) today announced the 34 science teachers in the United States, Canada and Puerto Rico who are this year’s recipients of the 19th annual Amgen Award for Science Teaching Excellence. The award recognizes extraordinary science teachers at the kindergarten through 12th grade level who significantly impact their students through exemplary science teaching and who achieve demonstrated results in student learning in communities where Amgen operates.

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Posted in Press Releases