Key Developments: Novartis AG (NVS)

NVS on New York Consolidated

19 Sep 2014
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Latest Key Developments (Source: Significant Developments)

Merus Labs International announces acquisition of Sintrom from Novartis AG
Monday, 8 Sep 2014 08:30am EDT 

Merus Labs International Inc:Says its subsidiaries, acquired the rights to manufacture, market, and sell the branded prescription medicine product Sintrom (acenocoumarol) from Novartis AG.Acenocoumarol is an anticoagulant indicated for the treatment and prevention of thromboembolic diseases.Other financial terms of the acquisition were not disclosed.  Full Article

Breckenridge Pharmaceutical Inc announces Paragraph IV ANDA litigation with Novartis AG for its ANDA Everolimus Oral Tablets
Friday, 5 Sep 2014 12:00pm EDT 

Breckenridge Pharmaceutical Inc:Announces that it has filed an ANDA with a Paragraph IV certification for Everolimus oral tablets, 0.25 mg, 0.5 mg, and 0.75 mg, a generic version of Zortress by Novartis AG.Says on Aug. 13, Novartis AG filed a lawsuit against Breckenridge in the United States District Court for the District of Delaware.Breckenridge submitted its Paragraph IV ANDA on the First-to-File date and expects to be the only generic that is entitled to the 180-day exclusivity period.Breckenridge's development partner, Natco Pharma Limited, will commercially manufacture this ANDA exclusively for Breckenridge.Zortress is a prescription drug that is indicated for the prophylaxis of organ rejection in adult patients, specifically for use in kidney and liver transplants.  Full Article

Novartis announces NEJM publication of two phase III studies demonstrating high efficacy of investigational new drug secukinumab (AIN457) in psoriasis patients
Tuesday, 5 Aug 2014 09:18am EDT 

Novartis AG:Says its Novartis Pharmaceuticals Canada Inc announced that detailed results from two pivotal phase III studies evaluating the interleukin-17A (IL-17A) inhibitor investigational secukinumab (AIN457) were published online in the New England Journal of Medicine.Investigational secukinumab met all primary and key secondary endpoints at Week 12.Superiority over placebo in both ERASURE and FIXTURE studies was demonstrated, while FIXTURE study also demonstrated superiority to Enbrel (etanercept) in improving moderate-to-severe plaque psoriasis symptoms.  Full Article

Novartis Alcon's Simbrinza approved in European Union to treat patients living with glaucoma
Monday, 28 Jul 2014 01:16am EDT 

Novartis AG:Says Alcon's Simbrinza approved in EU to treat patients living with glaucoma, chronic sight-threatening eye disease.Says launch of Simbrinza in the EU will start in UK in third quarter of 2014, followed by other European markets later in 2014 and in 2015.  Full Article

Novartis AG reaffirms FY 2014 outlook - Conference Call
Thursday, 17 Jul 2014 08:00am EDT 

Novartis AG:Reconfirms group outlook for FY 2014.Expects FY 2014 group net sales to grow low to mid single digits.Refines FY 2014 expectation for group core operating income growth to growing ahead of sales and growing mid to high single digit in constant currencies.Reported net sales of $57.920 billion and EBIT of $14.485 billion in FY 2013.FY 2014 revenue of $58.762 billion - Thomson Reuters I/B/E/S.  Full Article

Novartis AG submits application to FDA for meningitis B vaccine candidate Bexsero
Tuesday, 17 Jun 2014 08:00am EDT 

Novartis AG:Submission of Biologic License Application (BLA) to U.S. Food and Drug Administration (FDA) for marketing approval for use of Bexsero (Multicomponent Meningococcal Group B Vaccine [recombinant, adsorbed]).Says to help protect against invasive meningococcal disease caused by serogroup B (meningitis B) in adolescents and young adults from 10 years through 25 years of age.This submission initiates rolling submission process for Bexsero to the FDA, following the receipt of Breakthrough Therapy designation in April.  Full Article

Moody affirms all ratings of Novartis AG, outlook stable - Reuters
Thursday, 24 Apr 2014 06:52am EDT 

Novartis AG:Moody affirms all ratings of Novartis, outlook stable - Reuters.Affirmation of Novartis' rating follows analysis of rating implication of proposed four leg transaction announced by Novartis on April 22.This is regarding acquisition of GSK's oncology products, disposal of group's vaccines business (excluding the flu vaccines franchise) to GSK for, creation of consumer healthcare joint venture owned 36.5 pct by Novartis and sale of group's Animal Health business to Eli Lilly.Stable outlook assigned to current rating reflects Moody's expectation that Novartis to maintain financial policy going forward and that group's credit metrics to not drop materially below expectations for current rating pro-forma of the closing of transaction.  Full Article

Novartis AG confirms FY 2014 outlook
Thursday, 24 Apr 2014 02:43am EDT 

Novartis AG:Says FY 2014 outlook remains unchanged.Expects group net sales in FY 2014 to grow at low to mid-single digit rate (cc).Expects group core operating income to grow ahead of sales (cc) in FY 2014.FY 2013 net sales of $57.9 billion.FY 2013 core operating income of $14.5 billion.  Full Article

GlaxoSmithKline Consumer Healthcare Ltd announces GSK plc transaction with Novartis AG
Tuesday, 22 Apr 2014 06:00am EDT 

GlaxoSmithKline Consumer Healthcare Ltd:GSK Plc and Novartis AG have entered into an agreement to create consumer healthcare joint venture.To hold GSK's consumer healthcare business and Novartis OTC consumer healthcare business.JV will exclude GlaxoSmithKline Consumer Healthcare Ltd India, where GSK plc will continue to hold directly its interests in the listed entity.  Full Article

Novartis AG to divest Animal Health Division to Lilly for approximately $5.4 billion
Tuesday, 22 Apr 2014 01:00am EDT 

Novartis AG:To divest its Animal Health Division to Lilly for approximately $5.4 billion.This transaction is result of competitive process, which upon completion would create animal health business under Lilly's ownership and would optimize value of asset in interest of Novartis shareholders.Transaction with Lilly expected to close by end of first quarter of 2015.  Full Article

Switzerland takes on its top drugmakers in price row

* But Switzerland's big two are important to economy, jobs

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