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April 23, 2014
04:55 EDTAET, AET, AET, RNA, RNA, RNA, SHPG, SHPG, SHPG, ALXN, ALXN, ALXN, MSTX, MSTX, MSTX, NVS, NVS, NVS, SRPT, SRPT, SRPT, GENZ, GENZ, GENZ, FOLD, FOLD, FOLD, RXII, RXII, RXII, PFE, PFE, PFE, HUM, HUM, HUMTerrapinn to hold a conference
World Orphan Drug Congress is being held in Washington, D.C. on April 23-25.
News For HUM;PFE;RXII;FOLD;GENZ;SRPT;NVS;MSTX;ALXN;SHPG;RNA;AET From The Last 14 Days
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December 8, 2014
13:32 EDTPFEPfizer, Bristol-Myers announce results of human study on Eliquis
Bristol-Myers Squibb Company (BMY) and Pfizer (PFE) announced results of the first human study evaluating the reversal of the anticoagulant effect of Eliquis by 4-factor prothrombin complex concentrates in healthy subjects. The study results demonstrated that both PCCs, Sanquin’s Cofact and CSL Behring’s Beriplex P/N reversed the steady-state pharmacodynamic effects of Eliquis in several coagulation assessments, including endogenous thrombin potential. The full data will be presented today during the Antithrombotic Therapy: Anticoagulant Therapy session at the 56th annual meeting of the American Society of Hematology in San Francisco, CA. The study was an open label, randomized, placebo-controlled, three-period crossover study in 15 healthy, adult subjects. Within each period, subjects received Eliquis 10 mg twice daily. On day four, three hours after Eliquis administration, subjects received a 30-minute infusion of 4-factor PCCs, either 50 IU/kg Cofact or Beriplex P/N, or an equivalent volume of saline solution. The effect of Cofact and Beriplex P/N on the pharmacodynamics of Eliquis was based upon changes in endogenous thrombin potential, a measure of thrombin-mediated coagulation. Treatment periods were separated by an 11-day washout, after which the alternate treatment was administered. In this study, no serious adverse events, bleeding-related events or signs of thrombosis were reported with Eliquis administration with or without PCC treatment. Overall, these data demonstrate that Cofact and Beriplex P/N reversed the steady-state pharmacodynamic effects of Eliquis as measured by ETP and support further evaluation of PCCs in the management of patients treated with Eliquis who require reversal of its anticoagulant effect.
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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08:03 EDTPFEPfizer announces agreement with Spark Therapeutics to develop SPK-FIX
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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 7, 2014
14:10 EDTALXNAmerican Society of Hematology to hold a meeting
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December 5, 2014
13:41 EDTSHPGShire to host research and development day with a conference call hookup
Research and Development meeting to be held in New York on December 10 at 8 am. Webcast Link
10:22 EDTPFEBristol-Myers call activity attributed to takeover speculation
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10:05 EDTPFEBristol-Myers jumps 2% amid talk of potential Pfizer bid
Shares of Bristol-Myers (BMY) are up in early trading amid chatter of a potential takeover bid from Pfizer (PFE). The stock is up $1.26 to $60.15. Bristol's market capitalization stands around $99B, less than twice that of Pfizer's $200B. A Jefferies analyst last week called Mylan (MYL) the most likely takeover target for Pfizer. Pfizer is "highly motivated" to buy a foreign company using its overseas cash and Mylan looks like the most likely target, Jefferies analyst Jeffrey Holford wrote.
09:56 EDTPFERumor: Bristol-Myers strength attributed to takeover speculation
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09:41 EDTHUMHumana price target raised to $175 from $160 at Leerink
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08:01 EDTHUMWeight Watchers enters healthcare partnership with Humana
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06:58 EDTHUMHumana price target raised to $160 from $145 at Cantor
Cantor increased its price target on Humana as the firm expects Medicare and Medicaid enrollment to remain strong in 2014-15. The firm thinks the company is well-positioned to benefit from this trend, and it keeps a Buy rating on the shares.
06:21 EDTAETAetna to host investor meeting
Investor meeting to be held on December 11 at 8:30 am. Webcast Link
December 4, 2014
14:49 EDTSHPGSalix, Shire rise after analyst says merger would be 'attractive'
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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 EDTPFE, NVSAbbVie 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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