Specialty Pharma Journal Specialty, Precision & Technology
THOUSAND OAKS, Calif., Dec. 17, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ABP 710, a biosimilar candidate to REMICADE® (infliximab). “At Amgen, we have spent nearly four decades developing, manufacturing and producing transformative medicines. We’re leveraging our deep expertise and …
Tag Archives: amgen
December, 2018
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13 December
Amgen And Magellan Rx Management Collaborate To Improve Patient Care For Chronic, Difficult-To-Treat Conditions
THOUSAND OAKS, Calif., Dec. 11, 2018 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced a novel multi-year collaboration with Magellan Rx Management, the pharmacy benefit management division of Magellan Health, that will leverage each company’s capabilities and resources to identify clinical gaps for some of the healthcare system’s most difficult-to-treat diseases. …
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5 December
Amgen Announces First-In-Human Data Evaluating Investigational Novel BiTE Immunotherapies AMG 420 And AMG 330
THOUSAND OAKS, Calif., Dec. 3, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced the first clinical results from studies evaluating investigational novel bispecific T cell engager (BiTE®) immunotherapies AMG 420 and AMG 330. In two separate Phase 1 dose escalation studies, AMG 420, which targets B-cell maturation antigen (BCMA), and AMG 330, which targets CD33, …
November, 2018
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14 November
Amgen Presents Results Highlighting the Long-Term Safety and Efficacy of Repatha in the Longest Duration Study of a PCSK9 Inhibitor to Date
THOUSAND OAKS, Calif., Nov. 12, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced the final report of the Open-Label Study of Long-TERm Evaluation Against LDL-C (OSLER-1), demonstrating long-term treatment with Repatha® (evolocumab) was associated with robust and consistent reductions in low-density lipoprotein cholesterol (LDL-C), with no increase in overall rates of adverse events over time and no neutralizing antibodies. …
October, 2018
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24 October
Study Finds Enbrel Monotherapy and Combination Therapy Both Superior to Methotrexate in Patients with Psoriatic Arthritis
THOUSAND OAKS, Calif., Oct. 24, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that positive results from the Phase 3 SEAM-PsA study comparing the efficacy of Enbrel® (etanercept) monotherapy and ENBREL plus methotrexate to methotrexate monotherapy in patients with psoriatic arthritis (PsA) were presented in a late-breaking poster session at the 2018 American College of Rheumatology (ACR)/Association of …
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18 October
Amgen Invests $66 Million in Oxford Nanopore Technologies
THOUSAND OAKS, Calif. and OXFORD, England, Oct. 18, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) and Oxford Nanopore Technologies Ltd. today announced Amgen’s equity investment of £50 million ($66 million) in Oxford Nanopore, a privately-owned, UK-based company advancing a new generation of portable, real-time genetic sequencing technology. Oxford Nanopore has developed and brought to market a proprietary sequencing technology that uses many nanopores …
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3 October
FDA Approves Amgen’s sNDA for Kyprolis in Patients with Relapsed or Refractory Multiple Myeloma
THOUSAND OAKS, Calif., Oct. 1, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to expand the Prescribing Information for KYPROLIS® (carfilzomib) to include a once-weekly dosing option in combination with dexamethasone (once-weekly Kd70) for patients with relapsed or refractory multiple myeloma. The …
August, 2018
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27 August
Amgen Submits sNDA for Kyprolis in Combination with Dexamethasone for Treatment of Relapsed or Refractory Multiple Myeloma
THOUSAND OAKS, Calif., Aug. 27, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to expand the Prescribing Information for KYPROLIS® (carfilzomib) to include a once-weekly dosing option in combination with dexamethasone (Kd) for patients with relapsed or refractory multiple myeloma. The …
July, 2018
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20 July
Amgen and Cedars-Sinai Collaborate on Research, Health Service Redesign and Outcomes-Based Care
THOUSAND OAKS, Calif. and LOS ANGELES, July 19, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) and Cedars-Sinai Medical Center today announced a partnership to help support the improvement of healthcare quality in the treatment of multiple therapeutic areas that could include oncology, cardiovascular disease, osteoporosis and migraine. The organizations intend to jointly undertake research projects in one or more of …
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13 July
Amgen and UCB Resubmit BLA for Evenity to the FDA for the Treatment of Osteoporosis
THOUSAND OAKS, Calif. and BRUSSELS, July 12, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced the resubmission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for EVENITY™* (romosozumab), an investigational monoclonal antibody for the treatment of osteoporosis in postmenopausal women at high risk for fracture. EVENITY increases bone …