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Amgen to take 20.5% stake in Chinese biotech company BeiGene for $2.7bn

Amgen to take 20.5% stake in Chinese biotech company BeiGene for $2.7bn

US biopharma company Amgen has signed an all-cash deal to acquire a 20.5% stake in Chinese biotech company BeiGene for about $2.7 billion, as per the latest pharma acquisition news. The Beijing-based BeiGene is a research-based, oncology-focused biotechnology company, which is engaged in developing molecularly targeted and immuno-oncology drug candidates for cancer treatment. The transaction […]

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 […]

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Amgen to acquire Celgene psoriasis drug Otezla for $13.4bn

Amgen acquisition of Otezla : Amgen has agreed to acquire global rights to Celgene’s psoriasis drug Otezla (apremilast) for $13.4 billion, which includes $2.2 billion in expected future cash tax benefits. The deal is being executed to pave way for regulatory approval for the previously announced Bristol-Myers Squibb acquisition of Celgene in a deal worth […]

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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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Amgen scores pediatric FDA approval for Nplate in immune thrombocytopenia

Amgen’s Nplate (romiplostim) has been approved by the US Food and Drug Administration (FDA) for the treatment of pediatric patients with immune thrombocytopenia (ITP). The latest Nplate FDA approval is for patients of one year of age and older who have ITP for at least six months and who showed insufficient response to corticosteroids, immunoglobulins […]

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EC approves Mundipharma’s Neulasta biosimilar Pelmeg for neutropenia

Pelmeg EU approval : The European Commission (EC) has approved German pharma company Mundipharma’s Pelmeg, a pegylated version of granulocyte-colony stimulating factor (G-CSF) and also a biosimilar to Amgen’s neutropenia medication – Neulasta (pegfilgrastim). Pelmeg EU approval for Neutropenia The approval for Pelmeg is for its use as a treatment to bring down the duration […]

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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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Nivestym FDA approval : Pfizer’s Amgen neutropenia drug Neupogen biosimilar gets FDA nod

Nivestym FDA approval : Pfizer has bagged approval from the US Food and Drug Administration (FDA) for Nivestym (filgrastim-aafi) – a biosimilar to Neupogen (filgrastim) for all eligible indications of the reference Amgen neutropenia drug. Filgrastim is indicated in the US for neutropenia treatment among others. Neutropenia or low blood neutrophils, is a condition in […]

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