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FDA accepts BLA for Amgen’s Humira biosimilar, ABP 501
26 January 2016 | By Victoria White
Humira (adalimumab) is an anti-TNF-α monoclonal antibody which is approved in many regions for the treatment of several inflammatory diseases...
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Vectibix and best supportive care improves OS in mCRC
25 January 2016 | By Victoria White
Amgen has announced results from a study of Vectibix and best supportive care in patients with chemorefractory wild-type KRAS (exon 2) metastatic colorectal cancer (mCRC)...
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FDA approves new Kyprolis combination therapy in multiple myeloma
22 January 2016 | By Victoria White
The FDA has approved the supplemental New Drug Application (sNDA) of Amgen’s Kyprolis (carfilzomib) for injection in combination with dexamethasone or with lenalidomide plus dexamethasone...
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EC approves Imlygic as Europe’s first oncolytic immunotherapy
18 December 2015 | By Victoria White
The European Commission has approved the use of Amgen’s Imlygic (talimogen laherparepvec) for the treatment of adults with unresectable melanoma...
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Amgen reacquires product rights to 3 products from GSK
15 December 2015 | By Victoria White
Amgen has entered into a definitive agreement with GSK to reacquire all of its remaining rights to Prolia (denosumab), XGEVA (denosumab) and Vectibix (panitumumab) in 48 countries...
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Amgen presents new data on Kyprolis in multiple myeloma
7 December 2015 | By Victoria White
The data showed Kyprolis in combination with dexamethasone significantly extended disease progression compared to bortezomib plus dexamethasone...
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Amgen submits MAA for biosimilar ABP 501 to the EMA
4 December 2015 | By Victoria White
Amgen believes this submission is the first adalimumab biosimilar application submitted to the EMA and represents Amgen's first biosimilar to be submitted for approval in the EU...
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Amgen submits Biologices License Application for biosimilar ABP 501 to the FDA
26 November 2015 | By Victoria White
ABP 501 is a biosimilar candidate to AbbVie’s Humira (adalimumab), an anti-TNF-α monoclonal antibody, which is approved in many regions for the treatment of various inflammatory diseases...
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EC approves Blincyto for acute lymphoblastic leukaemia
24 November 2015 | By Victoria White
Blincyto is the first bispecific CD19-directed CD3 T cell engager (BiTE) antibody construct approved in European Union...
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EC grants marketing authorisation to Kyprolis in multiple myeloma
20 November 2015 | By Victoria White
The announcement makes Kyprolis (carfilzomib) the first irreversible proteasome inhibitor approved in the EU for use in combination treatment of patients with relapsed multiple myeloma.
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NICE says ‘no’ to Amgen’s Repatha in draft guidance
18 November 2015 | By Victoria White
The NICE Committee felt the question whether Repatha (evolocumab) would reduce angina, heart attacks and strokes remains unanswered...
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Study demonstrates clinical equivalence of ABP 501 with adalimumab
10 November 2015 | By Victoria White
ABP 501 is being developed as a biosimilar candidate to adalimumab, an anti-TNF-α monoclonal antibody, which is approved in many countries for the treatment of inflammatory diseases...
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FDA approves Imlygic for the treatment of melanoma lesions
28 October 2015 | By Victoria White
Imylgic is a genetically modified herpes simplex virus type 1 designed to replicate within tumours and produce an immunostimulatory protein called GM-CSF...
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Omecamtiv mecarbil improves cardiac function in chronic heart failure trial
27 October 2015 | By Victoria White
Omecamtiv mecarbil demonstrated statistically significant improvements in several measures of cardiac function, including systolic ejection time, stroke volume and N-terminal-pro-brain natriuretic peptide...
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CHMP adopts positive opinion for melanoma treatment Imlygic
23 October 2015 | By Victoria White
If approved by the European Commission, Imlygic would be the first in a class of novel agents known as oncolytic immunotherapies...
