Sandoz Inc. and Pear Therapeutics Obtain FDA Clearance for reSET-O(TM) to Treat Opioid Use Disorder

  • reSET-OTM is the first FDA-cleared Prescription Digital Therapeutic (PDT) for patients with Opioid Use Disorder
  • Pear Therapeutics is leading the development of a new therapeutic class with two FDA-authorized PDTs and a robust pipeline of therapeutics across disease areas
  • Sandoz will lead U.S. commercial launch, anticipated in coming days in Q4
  • As part of broader Novartis digital revolution, Sandoz aims to increase patient engagement and improve access to treatment through digital solutions

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Sandoz certified Top Employer Asia Pacific 2019

  • Sandoz has been certified by the Top Employers Institute for its exceptional employee offerings in Asia Pacific (APAC)
  • The annual, international research undertaken by the Top Employers Institute recognizes leading employers around the world
  • This exclusive certification underlines Sandoz´ commitment to build a great place to work

Holzkirchen, December 4, 2018 – Sandoz, a Novartis division, has been certified “TOP Employer Asia Pacific 2019” for its exceptional employee offerings in the region. Sandoz is certified in five Asia …

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Sandoz receives eighth European Commission approval for a biosimilar with Ziextenzo® (pegfilgrastim)

  • Biosimilar Ziextenzo® (pegfilgrastim), a long-acting version of supportive oncology medicine filgrastim, is now approved for use in all reference medicine indications [1]
  • Ziextenzo is indicated to reduce duration of neutropenia / incidence of febrile neutropenia, some of the most serious side effects of chemotherapy [2]
  • Sandoz demonstrates commitment to making access happen for patients with eight biosimilars approved in EU, including five in last 18 months

Holzkirchen, November 27, 2018 – Sandoz, a Novartis division …

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Sandoz and Pear Therapeutics announce launch of reSET® for treatment of patients with Substance Use Disorder

  • reSET® is the first and only FDA-authorized prescription digital therapeutic for Substance Use Disorder (SUD)
  • Adding reSET to outpatient therapy significantly improved abstinence in substances of abuse and treatment retention compared to standard of care alone
  • Sandoz and Novartis continue to embrace digital technologies to enhance R&D and deliver better outcomes for patients

Holzkirchen, November 19, 2018 – Sandoz, a Novartis division, and Pear Therapeutics, Inc., announced today the commercial launch …

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Sandoz commits to practical and scalable solutions to combat growing global threat of antimicrobial resistance (AMR)

  • Antibiotics are the cornerstone of modern medicine, but AMR represents an increasingly serious threat to global public health1
  • Sandoz, as the world’s leading provider of high-quality antibiotics, is committed to playing a key role in efforts to balance improved access and responsible use2
  • Focus is on driving practical, scalable on-the-ground solutions across four key areas, to help make a true impact and contribute to agreed global goals3

Holzkirchen, November 7, 2018 – …

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Sandoz decides not to pursue US biosimilar rituximab; will focus on robust biosimilar portfolio for unmet access and sustainability needs

  • Decision follows FDA request for additional information to complement submission for biosimilar rituximab
  • Sandoz stands behind safety, efficacy and quality of our biosimilar rituximab, which is already approved in EU, Switzerland, Japan and Australia
  • With seven biosimilars already approved globally, Sandoz will focus on progressing robust pipeline to enable early and expanded patient access and healthcare savings  

 

Holzkirchen, Germany, November 2, 2018 — Sandoz, a Novartis division and the pioneer and global …

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Sandoz 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 broader access to vital treatments for prevalent chronic conditions such as psoriasis and rheumatoid arthritis, which affect over eight million Americans combined
  • Hyrimozis third FDA-approved Sandoz biosimilar in US

 

Holzkirchen, Germany, October 31, 2018 — Sandoz, a Novartis division and the pioneer …

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Novartis delivered strong growth and innovation during the third quarter, including progressing advanced therapy platforms to drive future growth

  • Net sales grew 6% (cc[1], +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) driven by continued uptake worldwide
    • Promacta/Revolade USD 295 million (+32% cc), Tafinlar + Mekinist USD 291 million (+33% cc) and Jakavi USD 248 million (+27% cc) continued strong double-digit growth
    • AAA sales of USD 105 million, driven by the strong launch of …
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Novartis delivered strong growth and innovation during the third quarter, including progressing advanced therapy platforms to drive future growth

  • Net sales grew 6% (cc[1], +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) driven by continued uptake worldwide
    • Promacta/Revolade USD 295 million (+32% cc), Tafinlar + Mekinist USD 291 million (+33% cc) and Jakavi USD 248 million (+27% cc) continued strong double-digit growth
    • AAA sales of USD 105 million, driven by the strong launch of …
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Sandoz announces global resolution of biosimilar adalimumab patent disputes, securing patient access

  • Global 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 US market entry planned in 2023

Holzkirchen, October 11, 2018 – Sandoz, a Novartis division and the global leader in biosimilars, today announced a global resolution of all intellectual property (IP) related litigation with AbbVie concerning the proposed Sandoz biosimilar Hyrimoz® (adalimumab)[1] for …

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