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April 8, 2014
07:22 EDTGSK, NVS, BAX, UTHR, BIIB, SQNM, NVOCaSA-ISPE to hold a conference
21st Annual Lilfe Sciences Technology Conference is being held in Raleigh, North Carolina on April 8.
News For BIIB;NVS;NVO;UTHR;GSK;SQNM;BAX From The Last 14 Days
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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 5, 2014
06:04 EDTGSKGSK won't pursue divestment of certain brands in established products portfolio
As announced at the companyís Q2 results in July, GSK started a process to consider the divestment of certain North American and European brands in its Established Products Portfolio.The company has evaluated all bids received and has concluded, consistent with its key criteria of maximizing shareholder value, not to pursue divestment of these products.
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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December 3, 2014
17:33 EDTGSKGSK to shed U.S. jobs as Advair sales slow, Reuters says
GlaxoSmithKline confirmed U.S. job reductions saying "several hundred" commercial and research positions will be eliminated as the company consolidates its operations after the company's Advair sales slowed, says Reuters. Reference Link
16:30 EDTSQNMOn The Fly: Closing Wrap
Stocks on Wall Street opened quietly and trading remained muted through another session. Despite a host of economic data, including the Fedís Beige book report, the market moved in a narrow range, albeit toward record levels. The Fedís report confirmed the economy continues to improve, but at a slow pace. ECONOMIC EVENTS: In the U.S., Automatic Data Processing reported private payrolls increased 208k in November, versus expectations for 222K. Q3 nonfarm productivity grew 2.3%, versus expectations for an increase of 2.4%. Markit's final services PMI for November dropped to 56.2, which was below the 56.3 November flash print and down from October's 57.1 reading. The Institute for Supply Management's composite non-manufacturing index jumped to 59.3 in November from 57.1 in October, beating expectations for it to remain unchanged. The Federal Reserve Beige Book stated that the country's economy continued to expand in October and November. Consumer spending rose in most areas and the employment situation improved in many areas, while demand for nonfinancial services rebounded and lending held steady or increased, districts reported to the central bank. COMPANY NEWS: Carbonite (CARB) jumped $2.68, or 22.79%, to $14.44 after J2 Global (JCOM) offered to acquire all of the company's outstanding shares for $15.00 per share in cash. Carbonite's board will carefully "review and consider the offer," the company announced following its receipt of the unsolicited takeover bid. Investors reacted favorably to J2 Global's offer, sending its shares up $3.36, or 5.9%, to $60.33 as well. MAJOR MOVERS: Among the notable gainers was Sequenom (SQNM), which rose 72c, or 23.61%, to $3.77 after the company and a unit of Illumina (ILMN) agreed to settle all their pending infringement claims. Also higher was UTi Worldwide (UTIW), which jumped $2.34, or 20.28%, to $13.88 after Bloomberg, citing people with knowledge of the matter, reported that the company could reach an agreement to sell itself to Denmark-based DSV A/S as soon as this month. Among the noteworthy losers was Puma Biotechnology (PBYI), which sunk $27.33, or 12.15%, to $197.67 after the company delayed the filing for neratinib from the first half of 2015 to Q1 of 2016. Also lower were Class B shares of Brown-Forman (BF.B), which fell $3.75, or 3.91%, to $92.25 after the maker of Jack Danielís and other spirits reported lower than expected earnings and lowered its FY15 EPS view. INDEXES: The Dow rose 33.07, or 0.18%, to 17,912.62, the Nasdaq gained 18.66, or 0.39%, to 4,774.47, and the S&P 500 added 7.78, or 0.38%, to 2,074.33.
16:05 EDTGSK, NVSArray BioPharma to regain worldwide rights to Binimetinib
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12:39 EDTSQNMOn The Fly: Midday Wrap
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12:11 EDTNVSEMA finds no link between Novartis flu vaccine and deaths in Italy
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10:47 EDTSQNMSequenom settlement positive but reflected in stock price, says Ladenburg
Ladenburg views the settlement reached between Sequenom (SQNM) and Illumina (ILMN) as a near-term positive for Sequenom that gives more clarity on the competitive landscape, lowers its legal expenses and brings in needed capital. However, the firm believes the near-term financial benefit is reflected in the stock's valuation and maintains its Neutral rating on Sequenom shares.
09:35 EDTSQNMActive equity options trading
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09:23 EDTSQNMOn The Fly: Pre-market Movers
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07:09 EDTSQNMPiper Jaffray to hold a conference
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07:05 EDTBIIBBiogen to present data from hematology programs at ASH meeting
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06:07 EDTSQNMIllumina and Sequenom end patent dispute with partnership in prenatal testing
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