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Stock Market & Financial Investment News

News For PFE;ACT;JNJ;NVS;TEVA;MYL;GNK;BMY;GSK From The Last 14 Days
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March 3, 2015
06:02 EDTBMYBristol-Myers reports hepatitis C cure rate of 97% in study
A combination of two once-daily medications for chronic hepatitis C infection has been shown in newly released study results to cure almost all the patients who participated, despite the patients also being co-infected with HIV. This patient population historically has been challenging to treat for hepatitis C, in large part due to potential drug-drug interactions between the antiviral therapy regimens used to treat each infection. Results of ALLY-2, a Phase 3 clinical trial evaluating the investigational once-daily combination of daclatasvir and sofosbuvir for the treatment of chronic hepatitis C in patients co-infected with HIV were announced last week and showed that those treated for 12 weeks, 97% achieved cure. The ALLY-2 study met the primary endpoint, with 96% of treatment-na´ve genotype 1 patients achieving SVR12. Treatment with daclatasvir in combination with sofosbuvir in this study showed high SVR rates, with no discontinuations due to adverse events, and no serious adverse events related to study medications throughout the treatment phase. In ALLY-2, high SVR rates occurred among all patients treated for 12 weeks, regardless of prior treatment experience, HCV genotype, cirrhosis status, concurrent combination antiretroviral therapy regimen, or race. ALLY-2 also included an 8-week arm; 38 of 50 treatment-na´ve patients with HCV achieved SVR12. However, study investigators concluded that further studies are needed to assess the potential of shorter-duration, all-oral treatment regimens.
March 2, 2015
18:52 EDTMYLOn The Fly: After Hours Movers
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16:31 EDTPFEPfizer files automatic mixed securities shelf
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16:26 EDTJNJOn The Fly: Closing Wrap
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16:17 EDTMYLMylan sees FY15 adjusted gross margin 53%-55%
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16:16 EDTMYLMylan sees FY15 operating cash flow $1.6B-$1.8B; FY15 CapEx $400M-$500M
16:14 EDTMYLMylan says 'off to great start in 2015'
The company said, "We are off to a great start in 2015 with the recent completion of our acquisition of Abbott's non-U.S. developed markets specialty and branded generics business and the announcement of our proposed acquisition of Famy Care's women's health care businesses, and we expect that Mylan will deliver 33% revenue growth and 21% adjusted diluted EPS growth on a constant currency basis in 2015. In addition to these exciting activities, and as we have previously stated, you can continue to expect us to aggressively pursue additional acquisition opportunities that make financial and strategic sense for our company."
16:13 EDTMYLMylan sees FY15 adjusted EPS $4.00-$4.30, consensus $4.16
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16:12 EDTMYLMylan reports Q4 adjusted EPS $1.05, consensus $1.05
Reports Q4 revenue $2.08B, consensus $2.07B.
15:23 EDTMYLNotable companies reporting after market close
Notable companies reporting after the market close, with earnings consensus, include Mylan (MYL), consensus $1.05... Nabors Industries (NBR), consensus 39c... PRA Group (PRAA), consensus $1.11... Caesars Entertainment (CZR), consensus ($1.65)... Cumulus Media (CMLS), consensus 9c... Arena Pharmaceuticals (ARNA), consensus (12c)... Palo Alto Networks (PANW), consensus 17c... Guidewire Software (GWRE), consensus 11c... McDermott International (MDR), consensus (6c)... Salix Pharmaceuticals (SLXP), consensus (25c)... Matador Resources (MTDR), consensus 19c... Sanchez Energy (SN), consensus (11c).
12:13 EDTJNJOn The Fly: Midday Wrap
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11:52 EDTJNJJohnson & Johnson EPS dilution from Cordis deal seems modest, says Wells Fargo
Wells Fargo estimates that Johnson & Johnson's (JNJ) planned sale of Cordis to Cardinal Health (CAH) should dilute J&J yearly EPS by about 3c-4c, assuming all is else equal, and the firm expects the company to be able to absorb at least some of this dilution and possibly offset the rest via share repurchases. Wells maintains its Outperform rating on J&J shares.
09:28 EDTBMYBristol-Myers says FDA accepts Yervoy sBLA for review
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09:02 EDTPFEAstraZeneca mulls linking bonuses to Pfizer defense pledges, Sunday Times says
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08:47 EDTMYLMylan volatility elevated into Q4 and outlook
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08:31 EDTACTActavis receives approval from Europcean Commission for Xydalba
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08:24 EDTTEVATeva announces sale of Sellersville, PA facility to G&W Laboratories
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08:07 EDTNVSArray BioPharma announces completion of binimetinib and encorafenib transactions
Array BioPharma (ARRY) announced the completion of both the binimetinib and encorafenib definitive agreements with Novartis. Along with global ownership of both assets, Array will receive an upfront payment of $85M from Novartis (NVS). Effective March 2, 2015, Novartis' global, exclusive license to binimetinib terminated with all rights reverting to Array, and Array received global rights to encorafenib. Array will receive an $85M upfront payment from Novartis and reimbursement for certain transaction-related expenses. Novartis will provide transitional regulatory, clinical development and manufacturing services as specified below and will assign or license to Array patent and other intellectual property rights it owns to the extent they relate to binimetinib and encorafenib. Other than a de minimis payment to Novartis from Array, there are no milestone payments or royalties payable between the parties under the encorafenib agreement. As part of the transactions, Array has agreed to obtain an experienced partner for global development and European commercialization of both binimetinib and encorafenib. If Array is unable to find a suitable partner in the prescribed time period, a trustee would have the right to sell such European rights. Array entered into a third party agreement necessary to complete the transactions. Net consideration Array agreed to pay amounts to $25M. This payment is consistent with the earnings guidance provided on the quarterly conference call held on February 3, 2015. Novartis will reimburse Array for all remaining out-of-pocket expenses and half of all remaining FTE costs associated with MILO, which Array will continue to conduct. For NEMO and all other ongoing and planned clinical trials for binimetinib (other than COLUMBUS, as described above), Novartis will conduct and solely fund each trial, until a mutually agreed-upon transition date to Array. Following this transition, Novartis will reimburse Array for all remaining out-of-pocket expenses and half of all remaining FTE costs required to complete these studies. Novartis will remain responsible for conducting and funding development of the NRAS melanoma companion diagnostic until Premarket Approval is received from the U.S. Food and Drug Administration. Following approval, Novartis will transfer the product and Premarket Approval to a diagnostic vendor of Array's designation. Novartis also retains binimetinib and encorafenib supply obligations for all clinical and commercial needs for up to 30 months after closing and will also assist Array in the technology and manufacturing transfer of binimetinib and encorafenib. Novartis will also provide Array continued access to several Novartis pipeline compounds for use in currently ongoing combination studies, and possible future studies, including Phase 3 trials, with encorafenib and binimetinib.
08:01 EDTJNJCardinal Health offers to buy Cordis from Johnson & Johnson in $1.99B deal
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07:53 EDTJNJCardinal Health to host conference call
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