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December 2018
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Press Release
Alcon Announces Acquisition of Tear Film Innovations, Inc.
Acquisition further expands Alcon's portfolio of comprehensive solutions for patients with dry eye Tear Film's iLux® Device offers innovative, customizable treatment for Meibomian Gland… -
Press Release
Novartis receives European Commission approval for self-administration of Xolair® across all indications
The EC approval underscores the long-term safety and efficacy of Xolair demonstrated in clinical studies and by 13 years of real-world use in Europe[1] Xolair® (omalizumab) prefilled… -
Press Release
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… -
Press Release
Novartis data demonstrates consistent efficacy and tolerability of Kisqali® combination therapy in HR+/HER2- advanced breast cancer in patients with difficult-to-treat visceral disease
Subgroup analyses of three pivotal Phase III MONALEESA trials showed Kisqali plus endocrine therapy extended PFS in all patients with and without visceral involvement compared to endocrine… -
Press Release
Novartis investigational BYL719 (alpelisib) plus fulvestrant consistently improved PFS in patients with PIK3CA mutated HR+/HER2- advanced breast cancer in new SOLAR-1 analyses
BYL719 plus fulvestrant meaningfully prolonged PFS vs fulvestrant alone in patients with PIK3CA mutated HR+/HER2- advanced breast cancer after progression on an aromatase inhibitor… -
Press Release
Novartis advances ligelizumab (QGE031) in urticaria to Phase III on basis of strong Phase II head-to-head data
PEARL 1 and PEARL 2, the largest pivotal trials to date in chronic spontaneous urticaria (CSU), will enroll more than 2,000 CSU patients[1],[2] Ligelizumab (QGE031), a monoclonal antibody… -
Press Release
Novartis announces FDA filing acceptance and Priority Review of AVXS-101, a one-time treatment designed to address the genetic root cause of SMA Type 1
The AVXS-101, now known as ZOLGENSMA® (onasemnogene abeparvovec-xxxx)[1], filing is supported by data from the START trial which demonstrated a dramatic increase in survival and transformative… -
Press Release
Real-world data show Novartis drug Revolade® improves outcomes for ITP patients compared to other second-line therapies
Revolade (eltrombopag) showed lower rate of bleeding-related episodes and similar rate of thrombotic events vs. romiplostim, rituximab and splenectomy, in a retrospective analysis of US electronic… -
Press Release
Novartis announces longer-term analyses from pivotal Kymriah® trials that showed durable responses are maintained in patients with advanced blood cancers
In the updated analysis from ELIANA, Kymriah demonstrated an 82% remission rate within 3 months in pediatric patients with r/r ALL; relapse-free survival was 62% at 24 months, with median duration… -
Press Release
Novartis announces new crizanlizumab (SEG101) data analysis in sickle cell disease, and investment in SENTRY clinical program
New post-hoc analysis of SUSTAIN study, presented at ASH 2018, highlights results among patients who were treated per protocol compared with all randomized patientsCrizanlizumab, a monthly infusion…
November 2018
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Press Release
Novartis announces EU approval of Gilenya® for children and adolescents with MS, making it the first and only oral disease-modifying treatment for these patients in Europe
Approval based on landmark PARADIGMS study showing Gilenya (fingolimod) significantly reduced relapse rates by 82% vs interferon beta-1a; additionally, 85.7% of Gilenya patients were relapse-free… -
Press Release
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…