Key Developments: Novartis AG (NOVN.VX)

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Latest Key Developments (Source: Significant Developments)

Novartis AG says AIN457 (Secukinumab) meets primary endpoint in two phase III studies in ankylosing Spondylitis, a debilitating joint condition of spine
1:15am EDT 

Novartis AG:Says AIN457 (Secukinumab) meets primary endpoint in two phase III studies in ankylosing Spondylitis, a debilitating joint condition of spine.  Full Article

Novartis AG announces FDA Advisory Committee unanimously recommends approval of AIN457
Monday, 20 Oct 2014 03:10pm EDT 

Novartis AG:Says Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the US Food and Drug Administration (FDA) voted 7 to 0 to support the approval of AIN457 (secukinumab) for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy.DODAC based its recommendation on the safety and efficacy outcomes from 10 psoriasis Phase II/III clinical studies which included nearly 4,000 patients with moderate-to-severe plaque psoriasis.  Full Article

Novartis AG drug Afinitor is first treatment for advanced pancreatic net to provide overall survival of more than 3.5 years in phase III trial
Saturday, 27 Sep 2014 05:00am EDT 

Novartis AG:Presented final results on overall survival (OS) from Phase III trial of Afinitor (everolimus) tablets plus best supportive care (BSC) compared to placebo plus BSC in patients with well-differentiated advanced and progressive pancreatic neuroendocrine tumors (pNET).Overall survival was a secondary endpoint of the trial.Findings were presented at European Society for Medical Oncology (ESMO) Congress, Sept. 26-30, in Madrid, Spain, and are to be submitted to health authorities for inclusion in Afinitor prescribing information.Results from RADIANT-3 trial showed a median OS of 44.02 months (95 pct. confidence interval CI: 35.61, 51.75) in the everolimus treatment arm and 37.68 months (95 pct. CI: 29.14, 45.77) in placebo arm.6.34 month difference between two arms was not statistically significant (Hazard Ratio HR 0.94; 95 pct. CI: 0.73, 1.20; p=0.300).High crossover of patients from placebo to everolimus (85 pct.) likely contributed to the long median OS in the placebo arm of 37.68 months and may have confounded the ability to detect a difference in OS results.  Full Article

Novartis AG says Secukinumab meets primary endpoint in two phase III studies in psoriatic arthritis
Thursday, 25 Sep 2014 01:00am EDT 

Novartis AG:Says AIN457 (secukinumab) is first ever IL-17A inhibitor to meet primary endpoint in two Phase III studies in psoriatic arthritis.Says secukinumab met primary and key secondary endpoints in two pivotal Phase III studies showing superiority to placebo in patients with psoriatic arthritis (PsA).  Full Article

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

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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