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Thursday 21 March 2019
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Topic: amgen

June 20, 2018
Manufacturer Amgen has received approval from the European Commission (EC) to include overall survival (OS) data on the labels of the drug BLINCYTO (blinatumomab), it has announced.

Manufacturer Amgen has received approval from the European Commission (EC) to include overall survival (OS) data on the labels of the drug BLINCYTO (blinatumomab), it has announced.
 
The EC granted the company a full marketing authorisation for the drug based on the overall survival date from the Phase 3 TOWER study in adult patients with Philadelphia chromosome-negative (PH-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
 

March 26, 2018
Positive opinion for ABP 980 is supported by Phase III data in patients with HER2-postive early breast cancer

Amgen and Allergan have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorisation of ABP 980, a biosimilar to Herceptin® (trastuzumab).

 

February 9, 2018
XGEVA successfully met the primary endpoint, demonstrating non-inferiority to zoledronic acid in delaying the time to first on-study skeletal-related event in patients with multiple myeloma

Amgen has announced results from the XGEVA® (denosumab) Phase III ‘482 study, the largest international multiple myeloma trial for the prevention of skeletal-related events ever conducted (n=1718), were published in The Lancet Oncology.

 

In this study, XGEVA successfully met the primary endpoint, demonstrating non-inferiority to zoledronic acid in delaying the time to first on-study skeletal-related event in patients with multiple myeloma (HR=0.98, 95% CI: 0.85-1.14).
 

January 19, 2018
Marketing authorisation based on global development program showing MVASI is highly similar to Avastin® (bevacizumab)

Amgen and Allergan plc have that the European Commission (EC) has granted marketing authorisation for MVASI® (biosimilar bevacizumab).

 

August 24, 2017
Kyprolis is the first and only multiple myeloma therapy proven to extend overall survival in a head-to-head comparison with a current standard of care in the relapsed setting

Amgen has announced that results from an overall survival (OS) analysis of the Phase III head-to-head ENDEAVOR trial were published online first in The Lancet Oncology.

January 25, 2016
First Phase III Vectibix trial to include a prespecified analysis of efficacy endpoints by RAS tumour status in primary analysis. Results presented at Gastrointestinal Cancers Symposium 2016 reinforce importance of RAS testing

November 24, 2009
Amgen wins Best Overall Pipeline and Best New Drug for Nplate® at London ceremony, in recognition of market potential

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October 20, 2009
Biotechnology giant Amgen says the US FDA wants more information about its osteoporosis treatment Prolia before granting it market approval

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August 19, 2009
Studies published in the New England Journal of Medicine highlight potential new option in the treatment of bone loss

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August 14, 2009
Safety fears over Amgen's osteoporosis drug denosumab has prompted the US FDA to ban its use as a preventative treatment

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August 11, 2009
The New England Journal of Medicine publishes promising results

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May 26, 2009
Amgen is acquiring the rights to Cytokinetics's experimental heart drug CK-1827452

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February 9, 2009
New treatment for splenectomised adult chronic immune (idiopathic) thrombocytopenic purpura has been cleared for use in Europe

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May 27, 2008
Amgen's denosumab shows greater BMD gains than alendronate

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February 4, 2008
Amgen and Takeda Pharmaceutical Company Limited today announced an agreement under which Takeda will develop and commercialise for the Japanese market up to 13 molecules from Amgen

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January 28, 2008
Biotech conglomerate Amgen has revealed a rise in fourth-quarter profits despite a US regulator warning about the safety of its anaemia drugs.

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January 11, 2008
Pharmaceutical giant Amgen has revealed its cost-cutting drive will push profits higher than previously forecast.

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