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November 19, 2018 18:45 ET | Source: Novartis Pharma AG

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...
November 16, 2018 16:30 ET | Source: Novartis Pharma AG

FDA approves Novartis drug Promacta® for first-line SAA and grants Breakthrough Therapy designation for additional new indication

Promacta receives FDA approval for first-line treatment of severe aplastic anemia (SAA) and Breakthrough Therapy designation for low platelet counts in people exposed to radiation Approval...
November 16, 2018 08:09 ET | Source: Novartis Pharma AG

Novartis receives positive CHMP opinion to expand Kisqali® combination therapy to all women with HR+/HER2- locally advanced or metastatic breast cancer

Kisqali is the CDK4/6 inhibitor with the largest body of first-line evidence demonstrating consistent, superior and sustained efficacy vs. endocrine therapy alone[1] CHMP opinion is supported...
November 13, 2018 16:27 ET | Source: Novartis Pharma AG

Alcon files initial Form 20-F registration statement with SEC for proposed spinoff; plans investor days in New York and London

Basel, November 13, 2018 - Novartis today announced that Alcon has filed an initial Form 20-F registration statement with the US Securities and Exchange Commission (SEC) in relation to the...
November 11, 2018 11:45 ET | Source: Novartis Pharma AG

New Novartis study supports Entresto as foundational HFrEF therapy and in-hospital initiation in appropriate stabilized heart failure patients

Entresto® (sacubitril/valsartan) outperformed commonly used heart failure medicine enalapril in landmark study; delivered significantly greater and more rapid reductions in an established...
November 05, 2018 01:00 ET | Source: Novartis Pharma AG

Novartis R&D update highlights industry leading development pipeline including potential blockbusters and advanced therapy platforms

26 potential blockbusters in confirmatory development[1]. 13 projects in clinical development across Cell, Gene & Radioligand therapies. 60 major submissions[2] planned from 2019 to 2021 ...
November 02, 2018 18:00 ET | Source: Novartis Pharma AG

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...
November 02, 2018 17:15 ET | Source: Novartis Pharma AG

Novartis data at ASH and SABCS show strength of pipeline and portfolio in hematology and oncology

Additional analysis from pivotal Phase III SOLAR-1 clinical trial studying investigational alpha-specific PI3K inhibitor BYL719 (alpelisib) and fulvestrant in patients with PIK3CA-mutated...
October 31, 2018 12:30 ET | Source: Novartis Pharma AG

Sandoz receives US FDA approval for biosimilar Hyrimoz(TM) (adalimumab-adaz)

Biosimilar HyrimozTM (adalimumab-adaz) approved for all indications of reference medicine not protected by orphan exclusivity **Biosimilars are critical to sustaining US healthcare system,...
October 29, 2018 02:15 ET | Source: Novartis Pharma AG

Novartis announces clinical collaboration with Pfizer to advance the treatment of NASH

Agreement includes a clinical trial to evaluate a combination of tropifexor (LJN452) and one or more Pfizer compounds for the treatment of non-alcoholic steatohepatitis (NASH) Novartis has a...