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January 2018
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Press release
Sandoz regulatory submission for proposed biosimilar adalimumab accepted by FDA
Adalimumab is an anti-TNF medicine used to treat a range of immunological diseases[1] The comprehensive data package provided is expected to demonstrate that Sandoz proposed biosimilar adalimumab… -
Ad hoc release
Novartis appoints Elizabeth Barrett as Oncology Head
Novartis appoints experienced pharmaceuticals industry leader with strong marketing skills to drive oncology business further Novartis appoints ad interim leader for its Global Drug Development… -
Ad hoc release
Novartis ernennt Elizabeth Barrett zur Chefin Onkologie
Novartis ernennt eine erfahrene Pharma-Führungskraft mit starken Marketingfähigkeiten, um das Onkologiegeschäft weiter zu entwickeln Novartis ernennt ad interim Leiter für die Global Drug… -
Press release
Novartis advances head-to-head superiority trials of Cosentyx® versus Humira®* and proposed biosimilar adalimumab**
SURPASS is the first head-to-head superiority trial versus proposed biosimilar adalimumab** in ankylosing spondylitis (AS)[1] EXCEED is the first head-to-head superiority trial… -
Press release
REGENXBIO and AveXis Announce Expansion of Relationship through Amended License Agreement for the Development and Commercialization of Treatments for Spinal Muscular Atrophy
AveXis acquires exclusive rights to entire NAV Technology Platform for the development of treatments for SMA Amended agreement permits assignment by AveXis upon a change of control… -
Story Discovery
Organic dealmaker for drug discovery
New Global Head of Business Development and Licensing for research makes connections naturally, decisions scientifically.
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Story Discovery
Open science demystified
Jay Bradner discusses his vision for an open framework of scientific discovery at Novartis.
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Press release
AveXis Announces Alignment with FDA on Next Steps Toward a BLA Submission for AVXS-101 in SMA Type 1
– Company to submit information requested by FDA to the IND on an on-going basis – – AveXis plans to request a pre-BLA meeting in Q2 2018 – – Conference call and webcast today at 4:… -
Press release
Novartis drug Promacta® receives FDA Breakthrough Therapy designation for first-line use in severe aplastic anemia (SAA)
Data supporting designation showed over half of treatment-naïve SAA patients achieved complete response with Promacta when given with standard immunosuppressive therapy, with overall response rate of… -
Press release
Novartis Kisqali® received FDA Breakthrough Therapy designation for initial endocrine-based treatment in premenopausal women with HR+/HER2- advanced breast cancer
Designation based on Phase III MONALEESA-7 results demonstrating superior efficacy of Kisqali in combination with oral endocrine therapy compared to oral endocrine therapy in pre- or perimenopausal…
December 2017
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Press release
Novartis drug Tasigna® is approved by FDA as first and only CML therapy with Treatment-free Remission data in its label
Inclusion of Treatment-free Remission (TFR) data provides additional and novel option in management of Ph+ CML-CP Deep and sustained molecular response included as key eligibility criteria… -
Press release
Novartis' combination therapy Tafinlar® + Mekinist® granted FDA Priority Review for the adjuvant treatment of stage III BRAF V600 mutation-positive melanoma
Priority Review designation based on Phase III study showing 53% reduction in risk of recurrence or death with Tafinlar + Mekinist, as compared to placebo[1] Improvements observed in key…