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Home » Posts tagged with » David M. Reese
CANDOR clinical trial results : Amgen’s Kyprolis extends PFS in multiple myeloma patients

CANDOR clinical trial results : Amgen’s Kyprolis extends PFS in multiple myeloma patients

CANDOR clinical trial results : Amgen said that a phase 3 study assessing Kyprolis (carfilzomib) in combination with dexamethasone and Johnson & Johnson’s Darzalex (daratumumab) (KdD) compared to Kyprolis and dexamethasone alone (Kd), called CANDOR, met its primary endpoint of progression-free survival (PFS) in multiple myeloma patients. The Amgen clinical trial featured 466 relapsed or […]

Amgen seeks FDA approval for infliximab biosimilar ABP 710

Amgen has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for ABP 710, a biosimilar candidate to Johnson & Johnson’s REMICADE (infliximab). ABP 710 is being studied as a biosimilar candidate to infliximab, which is an anti-tumor necrosis factor alpha (anti-TNF) monoclonal antibody. Infliximab has approval in several regions […]

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FDA approves new dosing option for Amgen blood cancer drug Kyprolis

The US Food and Drug Administration (FDA) has approved a weekly once dosing option for Amgen blood cancer drug Kyprolis (carfilzomib) in combination with dexamethasone (once-weekly Kd70) for patients having relapsed or refractory multiple myeloma. The prescribing information has been expanded to include a new weekly once dosing of 70 mg/m2 of KYPROLIS. Approval for […]

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AstraZeneca, Amgen asthma drug tezepelumab secures FDA breakthrough designation

UK biopharma company AstraZeneca and Amgen have secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for their asthma drug tezepelumab. The FDA breakthrough therapy designation for tezepelumab is for the treatment of patients with severe asthma, without an eosinophilic phenotype, who are administered inhaled corticosteroids/long-acting beta2-agonists with or without oral corticosteroids […]

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Amgen blood cancer drug BLINCYTO scores EC approval in pediatric patients

The European Commission (EC) has approved an expanded indication for Amgen blood cancer drug BLINCYTO (blinatumomab) as monotherapy for the treatment of certain form of acute lymphoblastic leukemia (ALL) in pediatric patients aged one year or older. The pediatric approval of BLINCYTO is for the treatment of patients with Philadelphia chromosome-negative (Ph-) CD19 positive B-cell […]

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