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October 2018
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Media ReleaseSandoz receives US FDA approval for biosimilar Hyrimoz™ (adalimumab-adaz)Biosimilar Hyrimoz™ (adalimumab-adaz) approved for all indications of reference medicine not protected by orphan exclusivity Biosimilars are critical to sustaining US healthcare system, providing…
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Media ReleaseNovartis delivered strong growth and innovation during the third quarter, including progressing advanced therapy platforms to drive future growthNet sales grew 6% (cc1, +3% USD) mainly driven by: Cosentyx grew to USD 750 million (+37% cc) with strong volume growth across indications Entresto more than doubled to USD 271 million (+113% cc)…
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Media ReleaseSandoz announces global resolution of biosimilar adalimumab patent disputes, securing patient accessGlobal resolution secures patient access to Sandoz biosimilar Hyrimoz® (adalimumab)[1] for the reference medicine Humira®** Resolution paves way for 2018 launch in key European markets and secures…
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Media ReleaseSandoz Healthcare Access Challenge (HACk) returns, seeking digital solutions to local healthcare access challengesDespite major advances in modern medicine, universal access to healthcare remains the largest unmet medical need Building on the inaugural Sandoz HACk, this year’s competition expands to seek…
September 2018
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Media ReleaseSandoz receives positive CHMP opinion for proposed biosimilar pegfilgrastimPositive opinion is based on comprehensive data confirming that Sandoz biosimilar pegfilgrastim matches the reference medicine in terms of safety, efficacy and quality Sandoz seeks approval in the…
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Media ReleaseNovartis to divest the Sandoz US dermatology business and generic US oral solids portfolio to AurobindoNovartis to focus Sandoz division in US on higher growth areas and will sell selected portions of the Sandoz US portfolio to Aurobindo Pharma USA Inc. Agreement comprises the Sandoz US generic oral…
July 2018
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Media ReleaseSandoz receives European Commission approval for biosimilar Hyrimoz® (adalimumab)Biosimilar Hyrimoz® (adalimumab) approved for use in all same indications as reference medicine*** including rheumatology, gastroenterology and dermatology Early therapeutic intervention is…
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Media ReleaseNovartis delivers solid growth in second quarter and continues transformation to a focused medicines companyNet sales grew 5% (cc1, +7% USD) mainly driven by: Cosentyx grew to USD 701 million, (+40% cc) with strong growth in all indications in the US and EU Entresto sales more than doubled to USD 239…
June 2018
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Media ReleaseSandoz presents new long-term and switching data for biosimilars Zessly® (infliximab) and Erelzi® (etanercept) in rheumatoid arthritisZessly® (infliximab) matched the reference medicine in terms of safety and efficacy at 54 weeks, even in patients who switched from the reference medicine to Zessly1 Switching from the reference…
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Media ReleaseSandoz receives positive CHMP opinion for proposed biosimilar adalimumabSandoz is seeking approval of proposed biosimilar adalimumab for use in all reference medicine indications including those in rheumatology, gastroenterology and dermatology Positive CHMP opinion…
May 2018
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Media ReleaseSandoz receives European Commission approval for Zessly® (infliximab) in gastroenterological, rheumatological and dermatological diseasesSandoz receives European Commission approval for Zessly® (infliximab) in gastroenterological, rheumatological and dermatological diseases European Commission's (EC) approval based on comprehensive…
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Media ReleaseSandoz receives complete response letter from the US FDA for proposed biosimilar rituximabHolzkirchen, May 2, 2018 — Sandoz, a Novartis division, announced today that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the Biologics Licensing…
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