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Media Release / Dec 01, 2018
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…
Media Release / Dec 03, 2018
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…
Media Release / Dec 04, 2018
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…
Media Release / Dec 08, 2018
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…
Media Release / Dec 06, 2018
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…
Media Release / Dec 13, 2018
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…
Media Release / Dec 10, 2018
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…
Media Release / Dec 19, 2018
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…
Key Release / Dec 20, 2018
Novartis announces new CEO of Oncology Business Unit
Susanne Schaffert, Ph.D., President, AAA, an established Novartis executive, named new CEO, Novartis Oncology Basel, December 20, 2018 - Novartis announced today that Susanne Schaffert, Ph.D.,…
Media Release / Dec 19, 2018
Sandoz enters into commercialization and supply agreement for insulin biosimilars, anticipating growing demand as diabetes burden rises
Agreement covers biosimilar insulins in early and clinical development for the top three selling branded insulins by sales: glargine, lispro and aspart Over 400 million people worldwide have…