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January 2018
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Media 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… -
Media 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:… -
Media 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… -
Media 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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Media 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… -
Media 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… -
Media Release
Novartis announces Oncology head to retire
Basel, December 15, 2017 - Novartis announced today that Bruno Strigini, CEO Novartis Oncology has decided to retire from Novartis and the industry for personal reasons. Joseph Jimenez, CEO of… -
Media Release
Novartis gibt Rücktritt des Onkologie-Chefs bekannt
Basel, 15. Dezember 2017 - Novartis gibt bekannt, dass sich Bruno Strigini, CEO Novartis Onkologie, entschieden hat, die Firma aus persönlichen Gründen zu verlassen und sich aus der Industrie… -
Media Release
Novartis drug crizanlizumab shown to prolong time to patients' first sickle cell pain crisis in subgroup analysis of SUSTAIN study
Investigational therapy crizanlizumab (SEG101, formerly SelG1) approximately doubled the time to first on-treatment sickle cell pain crisis, according to new subgroup analysis of Phase II SUSTAIN… -
Media Release
Primary analysis results from Novartis pivotal JULIET trial show Kymriah(TM) (tisagenlecleucel) sustained complete responses at six months in adults with r/r DLBCL, a difficult-to-treat cancer
At six months, 30% of patients treated with Kymriah were in complete response, with a 74% relapse-free rate after onset of response; median duration of response was not reached Grade 3/4… -
Media Release
Sandoz announces new Phase I data showing proposed biosimilar pegfilgrastim matches reference medicine
Phase I study demonstrates matching pharmacokinetic (PK), pharmacodynamic (PD), safety and immunogenicity profiles of Sandoz biosimilar pegfilgrastim and reference medicine Pegfilgrastim is a… -
Media Release
Novartis tender offer for Advanced Accelerator Applications commences
Basel, December 7, 2017 -Novartis AG (NYSE: NVS) ("Novartis") today announced that its direct and indirect subsidiary, Novartis Groupe France S.A., a société anonyme organized under the laws of…