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FDA accepts application for generic version of Advair Diskus
The FDA has accepted Sandoz’s New Drug Application for fluticasone propionate / salmeterol combination product, a generic version of Advair Diskus...
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AAM praises Supreme Court Ruling granting access to biosimilars
The Association for Accessible Medicines (AAM) applauded the US Supreme Court’s decision this week in Sandoz Inc. v. Amgen Inc. that will help speed patient access to biosimilar versions of expensive brand-name biologic medicines.
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EMA to review Sandoz biosimilars adalimumab and infliximab
Sandoz announced that the EMA has accepted for regulatory review for biosimilars to AbbVie's Humira (adalimumab) and Janssen's Remicade (infliximab)...
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Sandoz proposed biosimilars recommended for EU approval
25 April 2017 | By Niamh Marriott, Junior Editor
The Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions, separately recommending the approval of both Sandoz's (a Novartis division) biosimilar rituximab and biosimilar etanercept in Europe, to treat the same indications as their respective reference medicines.
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Sandoz biosimilar adalimumab study shows equivalent efficacy
14 March 2017 | By Niamh Marriott, Junior Editor
Sandoz, a Novartis division, presented data for its proposed biosimilar adalimumab, GP2017, showing that their Phase III study met its primary endpoint...
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FDA committee recommends approval of Sandoz’s biosimilar etanercept
14 July 2016 | By Victoria White, Digital Content Producer
The Arthritis Advisory Committee voted unanimously in support of biosimilar etanercept for all five indications of the reference product...
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Sandoz announces EGALITY trial results for biosimilar etanercept
7 July 2016 | By Victoria White, Digital Content Producer
The EGALITY study involved 531 patients and compared the efficacy and safety of biosimilar etanercept with the originator product, Enbrel...
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Sandoz acquires rights to biosimilar infliximab in the EEA
12 February 2016 | By Victoria White
Infliximab is a tumour necrosis factor alpha (TNF-alpha) inhibitor used to treat a range of autoimmune diseases including rheumatoid arthritis and psoriasis...
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EMA accepts MAA for Sandoz’s biosimilar etanercept
8 December 2015 | By Victoria White
Sandoz is seeking approval for all indications included in the label of the reference product which is used to treat a range of autoimmune diseases including rheumatoid arthritis and psoriasis...
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FDA accepts Sandoz’s BLA for biosimilar etanercept
2 October 2015 | By Victoria White
Sandoz is seeking approval for all indications included in the label of etanercept which is used to treat a range of autoimmune diseases including rheumatoid arthritis and psoriasis...
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Sandoz opens new state-of the-art BioInject facility in Schaftenau
17 September 2015 | By Victoria White
BioInject will be used to manufacture pre-filled syringes and devices for both Sandoz’s biosimilars and Novartis Pharma’s novel biologics...
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Phase III data shows Sandoz’ investigational biosimilar filgrastim has similar safety and efficacy as Amgen’s NEUPOGEN®
8 December 2014 | By Novartis
Sandoz, a Novartis company, announced Phase III data that demonstrated similarity of its investigational biosimilar filgrastim compared to the US-licensed reference product, Amgen's NEUPOGEN ® (filgrastim) in the prevention of severe neutropenia in patients with breast cancer receiving neoadjuvant myelosuppressive chemotherapy...
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FDA accepts Sandoz application for biosimilar filgrastim
24 July 2014 | By Novartis
Sandoz announced that the US Food and Drug Administration has accepted its Biologics License Application for filgrastim...
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Sandoz joins forces with United Nations to combat a leading cause of child mortality worldwide
30 June 2014 | By Novartis
Sandoz announces a long-term commitment to help prevent the deaths of millions of children worldwide by supplying a key antibiotic formulation...
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Novartis emphasizes new focused portfolio at its first Meet Novartis Management investor day
18 June 2014 | By Novartis
For its first "Meet Novartis Management" investor day, Novartis gathered more than 20 of its top executives, drawn from the leadership of Pharmaceuticals...
