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News Breaks
November 20, 2012
16:41 EDTNVSNovartis: FDA approves new seasonal influenza vaccine, Flucelvax
The U.S. FDA announced the approval of Flucelvax, the first seasonal influenza vaccine licensed in the United States produced using cultured animal cells, instead of fertilized chicken eggs. Flucelvax is approved to prevent seasonal influenza in people ages 18 years and older. Reference Link
News For NVS From The Last 14 Days
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December 17, 2014
15:09 EDTNVSNovartis unit gets FDA approval for swimmer’s ear treatment
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07:29 EDTNVSFDA PDUFA Date for Novartis Bexsero is December 17, 2014
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December 16, 2014
08:47 EDTNVSHemispherx Ampligen provides anti-tumor activity
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07:06 EDTNVSBioLineRx and Novartis enter into strategic collaboration agreement
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05:48 EDTNVSNovartis gains FDA approval for Signifor LAR
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December 12, 2014
08:36 EDTNVSNovartis reports BOLERO-1 trial did not meet primary objective
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05:31 EDTNVSNovartis reports Cosentyx 'superior' in head-to-head psoriasis study
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December 8, 2014
13:07 EDTNVSNovartis announces data from Jakavi trial
Novartis (NVS) announced data from the largest clinical trial of myelofibrosis patients treated with Jakavi, supporting the safety profile and efficacy benefit as measured in primary and secondary endpoints respectively. In an analysis of 1,144 patients treated with Jakavi to date in this ongoing expanded access study, 69% of patients achieved >50% reduction in spleen size from baseline and patients also experienced a clinically meaningful improvement in myelofibrosis symptom score, important treatment goals for patients with myelofibrosis. Findings from the study were presented at the 56th Annual Meeting of the American Society of Hematology in San Francisco, California. Novartis research and development efforts, in collaboration with Incyte Corporation (INCY), include early-phase and post-marketing studies in myelofibrosis and other myeloproliferative neoplasms. More than 50 abstracts on ruxolitinib are being presented at ASH, including three oral presentations exploring combinations of ruxolitinib with various investigational compounds, evaluating the possibility of simultaneously targeting multiple cancer pathways that may be involved in the pathogenesis of myelofibrosis. The JUMP study is a Phase IIIb, expanded-access trial for countries with no access to Jakavi outside of a clinical trial. The open-label, multicenter study analyzed 1,144 enrolled myelofibrosis patients who received daily starting doses of either 5 mg, 15 mg or 20 mg of Jakavi twice daily based on platelet counts at baseline. The primary endpoint is assessment of safety and tolerability of Jakavi. Overall, the safety and efficacy profile of Jakavi was consistent with previous studies.
13:05 EDTNVSNovartis reports six-year results from Phase III ENESTnd study
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11:30 EDTNVSLeerink generics pharmaceutical analyst holds analyst/industry conference call
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05:42 EDTNVSSandoz Phase III data shows filgrastim has similar safety, efficacy as NEUPOGEN
Sandoz, a Novartis (NVS) company, announced Phase III data that demonstrated similarity of its investigational biosimilar filgrastim compared to the US-licensed reference product, Amgen's (AMGN) NEUPOGEN in the prevention of severe neutropenia in patients with breast cancer receiving neoadjuvant myelosuppressive chemotherapy. The study also showed that repeated switching at each cycle between the investigational biosimilar and the originator filgrastim showed no impact on efficacy, safety or immunogenicity. The PIONEER study was a Phase III study designed to compare the efficacy and safety of the investigational biosimilar and the reference product with respect to mean duration of severe neutropenia following Cycle 1 chemotherapy. PIONEER was a randomized, double-blind, four-group, multi-center non-inferiority trial conducted at 27 centers. The trial randomized 218 breast cancer patients receiving neoadjuvant myelosuppressive chemotherapy.
December 4, 2014
12:22 EDTNVSOn The Fly: Midday Wrap
Stocks on Wall Street began the session slightly lower despite relatively in-line jobless claims data, as European markets moved down following a rate decision and accompanying commentary from ECB President Mario Draghi. Adding to the modest pressure seen in morning trading may be the fact that oil prices continue to move lower. ECONOMIC EVENTS: In the U.S., initial jobless claims fell 17K to 297K in the week ended November 29, which was nearly in-line with the expectation for 295K first-time claims. Challenger reported announced layoffs fell 15.2K in November to 35.9K. In Europe, the European Central Bank kept its key rates unchanged, as expected. ECB President Mario Draghi said in his accompanying press conference that the latest euro area macroeconomic projections indicate lower inflation, accompanied by weaker real GDP growth and subdued monetary dynamics. Additionally, he stated that early next year the Governing Council will reassess the monetary stimulus achieved, the expansion of the balance sheet and the outlook for price developments. "Should it become necessary to further address risks of too prolonged a period of low inflation, the Governing Council remains unanimous in its commitment to using additional unconventional instruments within its mandate. This would imply altering early next year the size, pace and composition of our measures," Draghi said. COMPANY NEWS: Shares of Barnes and Noble (BKS) slid about 10% after the company reported lower than expected second quarter earnings and said it continues to expect both Retail comparable bookstore sales and Retail Core comparable bookstore sales to decline in the low-single digits this fiscal year. Additionally, Barnes & Noble and Microsoft (MSFT) agreed to terminate their commercial agreement and B&N agreed to acquire Microsoft's entire preferred interest in NOOK Media in exchange for $62.4M cash and 2.74M shares of its stock. MAJOR MOVERS: Among the notable gainers was Hawaiian Electric (HE), which jumped 16% after its board approved a plan to spin off ASB Hawaii, the parent company for American Savings Bank, and establish it as an independent publicly traded company and NextEra Energy (NEE) agreed to acquire the company, excluding the banking subsidiary. Array BioPharma (ARRY) rose 15% after announcing it has reached a definitive agreement with Novartis (NVS) to regain full worldwide rights to binimetinib, a MEK inhibitor in three Phase 3 trials, which Piper Jaffray called a "big win" for the company. Among the noteworthy losers was UTi Worldwide (UTIW), which fell 11.5% after confirming that exploratory conversations have taken place with DSV, but adding those discussions never progressed beyond a preliminary stage and that no talks are currently taking place. Also lower were shares of Express (EXPR), which declined over 9% after the apparel retailer reported lower than expected Q3 revenue and gave EPS guidance that fell short of estimates. INDEXES: Near midday, the Dow was down 53.56, or 0.3%, to 17,859.06, the Nasdaq was down 2.80, or 0.06%, to 4,771.67, and the S&P 500 was down 5.49, or 0.26%, to 2,068.84.
09:15 EDTNVSArray BioPharma to host conference call
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08:45 EDTNVSAbbVie price target raised to $80 from $72 at Jefferies
Jefferies raised its price target for AbbVie shares to $80 while calling the company one of its top five global pharma picks for 2015. The firm's top U.S. pick is Pfizer (PFE) and its top Europe pick is Novartis (NVS). Bayer (BAYRY) and AstraZeneca (AZN) round out the top five. Jefferies thinks AbbVie's "strong momentum" will continue into the first half of 2015 and keeps a Buy rating on the name.
05:54 EDTNVSArray BioPharma regaining binimetinib a 'big win,' says Piper Jaffray
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