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Amgen, Allergan file BLA to FDA for Rituxan biosimilar ABP 798

Amgen, Allergan file BLA to FDA for Rituxan biosimilar ABP 798

Rituxan biosimilar ABP 798 : US biopharma company Amgen and Irish pharma company Allergan have submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for ABP 798, a biosimilar candidate to Roche’s cancer drug Rituxan (rituximab). Rituxan, which is a CD20-directed cytolytic antibody, has approval across various regions for the […]

Bristol-Myers Squibb wraps up $74bn acquisition of Celgene

Bristol-Myers Squibb has wrapped up its $74 billion acquisition of Celgene having got regulatory approval from all government authorities necessary for closing the merger agreement along with approvals from stockholders of the two companies. Celgene has now become a fully-owned subsidiary of Bristol-Myers Squibb and as per the merger terms, shareholders of the former have […]

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FTC clears decks for Bristol-Myers Squibb acquisition of Celgene

Bristol-Myers Squibb acquisition of Celgene : US pharma giant Bristol-Myers Squibb said that the US Federal Trade Commission (FTC) has given its clearance for its previously announced $74 billion acquisition of American biotech company Celgene. The FTC has accepted the proposed consent order regarding the pending merger of Bristol-Myers Squibb and Celgene, thereby allowing the […]

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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 […]

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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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