Key Developments: Novartis AG (NOVN.VX)

NOVN.VX on Virt-X Level 1

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24 Oct 2014
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Latest Key Developments (Source: Significant Developments)

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

Novartis AG's OTC and GSK Consumer Healthcare to form joint venture
Tuesday, 22 Apr 2014 01:00am EDT 

Novartis AG:Says agreed with GSK to create consumer healthcare business through joint venture between Novartis OTC and GSK Consumer Healthcare.Upon completion, Novartis to own 36.5 pct share of joint venture and to have four of eleven seats on joint venture's Board.Novartis to have customary minority rights and exit rights at pre-defined, market-based pricing mechanism.  Full Article

Novartis AG to acquire GlaxoSmithKline plc oncology products; to divest Vaccines business to GSK, excluding flu business
Tuesday, 22 Apr 2014 01:00am EDT 

Novartis AG:Announces it has reached definitive agreement with GlaxoSmithKline plc (GSK) to exchange certain assets, building global leadership in key segments and focusing company's portfolio.Under agreement, Novartis would strengthen company's pharmaceuticals business by acquiring GSK oncology products, and would divest Vaccines (excluding flu) to them.Novartis has agreed to acquire GSK oncology products for $14.5 billion payment and up to $1.5 billion contingent on development milestone.Under terms of transaction, Novartis would have opt-in rights to GSK's current and future oncology R&D pipeline.Has agreed to divest its Vaccines business to GSK, excluding its flu business, for $7.1 billion plus royalties.Says $7.1 billion consists of $5.25 billion upfront and up to $1.8 billion in milestones.As part of value-maximization strategy in context of portfolio review, Novartis has initiated separate sales process for its flu business.  Full Article

France's competition authority investigates Roche Holding AG and Novartis AG in relation to eye disease treatments - Reuters
Wednesday, 9 Apr 2014 08:00pm EDT 

Novartis AG:France's competition authority is investigating Roche and Novartis on suspicion they were involved in anti-competitive practices in relation to eye disease treatments - Reuters.This is second time in as many months that Swiss drugmakers have faced regulatory scrutiny over treatments for wet age-related macular degeneration (AMD)- cause of blindness among elderly.Last month, prosecutors in Rome opened investigation into four executives at Swiss drugmakers on suspicion of fraud and manipulation of pharmaceutical market, according to judicial sources.Earlier in March, Italy's antitrust authority said Roche and Novartis colluded to try to stop cancer drug Avastin from being used to treat AMD and fined companies 182.5 million euros ($254.2 million).Regulator accused firms of striking alliance to prevent distribution of Roche's Avastin in favour of the more expensive drug Lucentis made by Novartis.  Full Article

FDA Advisory Committee votes against approval for Novartis AG's RLX030
Thursday, 27 Mar 2014 05:08pm EDT 

Novartis AG:Announces US Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted against approval for RLX030 (serelaxin) for treatment of acute heart failure (AHF.Data presented included phase II and III efficacy and safety data from the RLX030 clinical development program, including pivotal phase III RELAX-AHF study.In this study RLX030 improved symptoms of acute heart failure (AHF) through reducing rate of worsening heart failure, measure of symptom deterioration that requires intensification of therapy.RLX030 under review to improve symptoms of AHF through reduction of rate of worsening of heart failure.  Full Article

Novartis AG study published in NEJM shows LDK378 demonstrates overall response rate of 58 pct in patients with ALK+ NSCLC
Wednesday, 26 Mar 2014 05:00pm EDT 

Novartis AG:Announces New England Journal of Medicine (NEJM) published clinical trial results showing investigational compound LDK378 (ceritinib) achieved overall response rate of 58 pct.Says LDK378 median progression-free survival (PFS) of seven months in adults with advanced anaplastic lymphoma kinase positive (ALK+) non-small cell lung cancer (NSCLC) who received 400 mg or higher of LDK378 per day.Study evaluated 114 ALK+ NSCLC patients treated with LDK378, including patients who had progressed during or following treatment with commonly prescribed ALK inhibitor called crizotinib and those who had not received prior treatment with an ALK inhibitor.This study is part of ongoing Novartis clinical trial program in this patient population.Says most frequent adverse events were nausea (82 pct), diarrhea (75 pct), vomiting (65 pct), fatigue (47 pct) and increased alanine aminotransferase levels (35 pct).  Full Article

New phase III psoriasis data show rapid, significant skin clearance and convenient administration with Novartis AG' secukinumab
Saturday, 22 Mar 2014 02:15am EDT 

Novartis AG:Announces results from pivotal phase III FEATURE and JUNCTURE studies showing secukinumab (AIN457), interleukin-17A (IL-17A) inhibitor, demonstrated consistent high efficacy when administered with convenient pre-filled syringe (PFS) or autoinjector/pen (AI).These results, along with patient-reported outcomes showing high patient satisfaction with PFS and AI 3,4, are being presented for first time at 72nd annual meeting of the American Academy of Dermatology (AAD) in Denver, USA.In both studies more secukinumab 300 mg patients experienced almost clear skin, described as Psoriasis Area and Severity Index 90 (PASI 90), at Week 12 (60.3 pct. for FEATURE and 55 pct. for JUNCTURE, p <0.0001) compared to placebo.PASI 90 is considered best evidence of efficacy, and a more robust measure of the extent of skin clearance compared to standard efficacy measures that have been used in most psoriasis clinical studies, such as PASI 75.  Full Article

Novartis reports positive results in spinal inflammation condition

ZURICH - Swiss drugmaker Novartis said on Thursday two late-stage trials showed its drug secukinumab improved symptoms of ankylosing spondylitis, a debilitating joint condition of the spine.

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