Key Developments: Novartis AG (NVS)
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23 May 2013
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Latest Key Developments (Source: Significant Developments)
Novartis AG Recalls Cough Syrups Due To Cap Seal Defect-Reuters
Reuters reported that Novartis AG said it is recalling 183 lots of cough syrup after discovering the child-resistant feature on some bottle caps was not functioning correctly. The Swiss drug company is recalling 142 lots of Triaminic and 41 lots of Theraflu Warming Relief Syrups manufactured in the United States before December 2011. The Company said it received four reports of accidental ingestion of the Triaminic syrup. One patient required medical attention but recovered. No adverse affects were reported with the Theraflu syrup, but the product is being recalled because it has the same cap as the malfunctioning Triaminic bottles. Full Article
EU Regulator Charges Johnson & Johnson, Novartis AG Over Dutch Painkiller Delay-Reuters
Reuters reported that EU regulators stepped up their fight against drug companies suspected of blocking cheap generic medicines, charging Johnson & Johnson and Novartis AG over a painkiller called fentanyl. Full Article
Novartis AG's CEO Tempers Talk Of Roche Holding AG Stake Sale-Reuters
Reuters reported that Novartis AG's Chief Executive (CEO) Joe Jimenez played down talk that it was looking to sell its one-third voting stake in Roche Holding AG, and certainly not at its current market price. There has been widespread speculation that the Novartis could be heading for a change of strategic direction, including a possible sale of the Roche stake. Full Article
Novartis AG Announces FDA Approval For Exjade In Patients With Genetic Blood Disorder-Reuters
Reuters reported that U.S. regulators said on January 23, 2013 they have approved Novartis AG's drug Exjade to remove excess iron in patients over the age of 10 who have a genetic blood disorder known as non-transfusion-dependent thalassemia, or NTDT. The new approval allows Novartis to also market the drug for NTDT. Patients with thalassemia have an abnormal form of hemoglobin, the protein in red blood cells that carries oxygen. The malfunction leads to the presence in the body of fewer red blood cells than normal. As a result patients may develop severe anemia and need regular blood transfusions. NTDT is a milder form of thalassemia that does not require frequent transfusions. Patients with the condition are nonetheless at risk of iron overload, which can lead to damage of various organs and potentially premature death. The new approval was given under the FDA's accelerated approval program, which gives patients earlier access to promising new treatments intended to treat serious or life-threatening illnesses while the Company conducts additional studies to confirm its clinical benefit. Exjade was approved based on clinical data showing it can reduce liver iron concentrations, which the FDA judged reasonably likely to predict a clinical benefit to patients. Full Article
Novartis AG Issues FY 2013 Revenue Guidance In Line With Analysts' Estimates-Conference Call
Novartis AG announced that for fiscal 2013, it expects Group net sales expected to be in line with 2012. The Company reported revenue of $56.67 billion in fiscal 2012. According to I/B/E/S Estimates, analysts are expecting the Company to report revenue of $57.2 billion for fiscal 2013. Full Article
Novartis AG Names New Chairman-Reuters
Reuters reported that Novartis AG's Chairman Daniel Vasella will step down in February 2013 and has named Joerg Reinhardt, as its new chairman from August 1, 2013. Full Article
Novartis AG Receives European Approval For Meningitis B Vaccine-Reuters
Reuters reported that Novartis AG has clinched European approval for the first vaccine against meningitis B, and will seek to sell the drug as soon as possible. Full Article
Novartis AG Announces Phase III Data In The Lancet show
Novartis AG announced data in The Lancet showed that patients on Afinitor (everolimus) tablets with non-cancerous kidney tumors known as renal angiomyolipomas associated with tuberous sclerosis complex (TSC) experienced a significant reduction in tumor size and the absence of tumor progression. Additionally, a recent issue of The Lancet featured results from a separate everolimus trial demonstrating a reduction in the size of non-cancerous brain tumors known as subependymal giant cell astrocytomas (SEGAs) associated with TSC 2. The Phase III EXIST-2 trial published in The Lancet reported that 42% of patients taking everolimus experienced an angiomyolipoma response versus 0% of patients in the placebo arm (p<0.0001). Everolimus also demonstrated superiority to placebo for both secondary endpoints assessed. Time to angiomyolipoma progression was statistically significantly longer in patients on everolimus versus placebo (p<0.0001). In patients with skin lesions, a key concern for those with TSC, a 26% response rate was seen with everolimus versus 0% with placebo (p=0.0002). Results from a separate Phase III trial of TSC patients called EXIST-1, also published in a recent issue of The Lancet , showed that 35% of patients with SEGAs associated with TSC treated with everolimus experienced a 50% or greater reduction in SEGA volume versus 0% of patients on placebo (p<0.0001). Full Article
Novartis AG's Drug Signifor Gains FDA Approval As First Medication To Treat Cushing's Sisease
Novartis AG announced that the US Food and Drug Administration (FDA) has approved Signifor (pasireotide) injection for the treatment of adult patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative3. Signifor is the first medicine to be approved in the US that addresses the underlying mechanism of Cushing's disease, a serious, debilitating endocrine disorder caused by the presence of a non-cancerous pituitary tumor which ultimately leads to excess cortisol in the body1,4. This approval follows a unanimous recommendation from the FDA Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) in support of the use of Signifor. The approval is based on data from PASPORT-CUSHINGS (PASireotide clinical trial PORTfolio - CUSHING'S disease), the largest randomized Phase III study to evaluate a medical therapy in patients with Cushing's disease3. Results from the PASPORT-CUSHINGS study found that a decrease in mean urinary-free cortisol (UFC), the key measure of biochemical control of the disease, was sustained during the treatment period in most patients, with a subset of patients reaching normal levels. The study also showed that certain clinical manifestations of Cushing's disease tended to improve. Full Article
FDA Approves Novartis AG's Seasonal Flu Vaccine-Reuters
Reuters reported that The U.S. Food and Drug Administration said it has approved a seasonal flu vaccine produced by Novartis AG using animal cell culture rather than the traditional manufacturing using chicken eggs. The vaccine, to be sold by the Swiss drugmaker under the brand name Flucelvax, is approved to prevent season influenza in people aged 18 and over, the agency said. Full Article
Novartis, BT push European shares to fresh 5-yr peak
LONDON, May 10 - European shares scaled fresh five-year highs on Friday, led by healthcare group Novartis and telecoms firm BT on positive corporate news, and traders said key indexes had scope for more gains.
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