Top: At Amgen San Francisco, from left to right, Tassie Collins, senior principal scientist; Frank Kayser, senior principal scientist; and Dan Lin, senior scientist

Middle: At Amgen Australia, from left to right, Max Colao, director of Sales and Marketing; Kaylene O'Shea, director of Scientific Affairs; and Russell Edwards, regional director, Southeast Asia, Amgen Australia Pty Ltd.

Bottom: Volunteering at a food bank in Boulder, Colorado, from left to right, Terry Quirk, site security manager for Amgen Colorado, and Hunyen Lee, engineering project manager

The U.S. Food and Drug Administration (FDA) approves Amgen's first small-molecule therapy, Sensipar® (cinacalcet HCl), for the treatment of secondary hyperparathyroidism caused by chronic kidney disease. It is approved for the same indication in Canada, and, under the name Mimpara®, in Europe.

FDA approves Kepivance™ (palifermin) to decrease the incidence and duration of severe oral mucositis (mouth sores) in patients with hematologic (blood) cancers undergoing high-dose chemotherapy, with or without radiation, followed by bone marrow transplant. The safety and efficacy of Kepivance™ have not been established in patients with non-hematologic malignancies.

The European Commission approves extended Aranesp® (darbepoetin alfa) dosing intervals.

FDA approves the use of ENBREL® (etanercept) for the treatment of adult (18 years or older) patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

FDA approves a 50 mg/mL pre-filled syringe as the recommended dosing form for ENBREL® for use in all approved adult indications. The new pre-filled syringe eliminates the need to mix the drug prior to injecting and allows many adult patients receiving ENBREL® to take only one injection per week, instead of two 25 mg injections per week.

Amgen initiates a landmark trial to evaluate the impact on cardiovascular outcomes of treating anemia in patients with chronic kidney disease and type 2 diabetes. TREAT (Trial to Reduce cardiovascular Events with Aranesp® Therapy) is one of the largest clinical trials in the company's history.

Ten new molecules are cleared to enter development.

Amgen commences five new first-in-human clinical trials in the United States and four in Japan.

Pivotal studies of Sensipar® and Kepivance™ are published in the New England Journal of Medicine.

Phase 3 trials begin for AMG 162, a fully human monoclonal antibody being investigated for potential use in post-menopausal osteoporosis and treatment-induced bone loss. The trials, in which Amgen intends to enroll thousands of patients, will be the largest ever conducted by the company.