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News For NVO;VPHM;INFI;MRK;AGN;SHPG;SGEN;OREX;AMGN;SNY;JNJ;PFE From The Last 14 Days
Check below for free stories on NVO;VPHM;INFI;MRK;AGN;SHPG;SGEN;OREX;AMGN;SNY;JNJ;PFE the last two weeks.
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August 18, 2014
08:01 EDTPFEPfizer announces submission of Palbociclib NDA to FDA
Pfizer announced it has completed the submission of a New Drug Application to the United States Food and Drug Administration for palbociclib. This NDA requests FDA approval of palbociclib, in combination with letrozole, for the treatment of postmenopausal women with estrogen receptor positive, human epidermal growth factor receptor 2 negative advanced breast cancer who have not received previous systemic treatment for their advanced disease. The submission is based on the final results of PALOMA-1, a randomized, Phase 2 trial comparing palbociclib plus letrozole versus letrozole alone in this population of patients. Palbociclib received Breakthrough Therapy designation from the FDA in April 2013, for the first-line systemic treatment of women with advanced or metastatic ER+, HER2- breast cancer. This designation was based on interim data from the PALOMA-1 trial. The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing. Pfizer will communicate the Agency’s decision.
07:57 EDTAGN, PFE, MRK, SHPGCambridge Healthtech Institute to hold a summit
6th Annual Bioprocessing Summit to be held in Boston on August 18-22.
August 15, 2014
17:03 EDTAGNValeant extends offer to acquire Allergan
Valeant Pharmaceuticals (VRX) announced that it has extended the expiration of its exchange offer to acquire all of the outstanding shares of Allergan (AGN) to December 31. The exchange offer was previously scheduled to expire August 15. All other terms and conditions of the exchange offer remain unchanged.
14:14 EDTAGNValeant being probed by IRS after Biovail deal, FT says
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09:45 EDTAGNEvent-driven funds, Pershing own over 20% of Allergan, CNBC reports
Event-driven hedge funds and Pershing Square owned over 20% of Allergan as of June 30, CNBC's David Faber reports. Valeant (VRX) and Pershing are seen as getting the over 30% to call a special meeting, Faber adds.
06:54 EDTAMGNAmgen shares should 'grind higher' this year, says RBC Capital
RBC Capital expects Amgen shares to "grind higher" this year driven by a greater appreciation of pipeline programs, the Analyst Day on October 28, an expected filing of the PCSK-9 program soon, and positive Ph iiB anti-CGRP migraine data expected year-end. Shares are Outperform rated.
August 14, 2014
17:16 EDTAGN, SHPGPaulson & Co gives quarterly update on stakes
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17:05 EDTPFEPfizer says FDA accepted for review BLA for bivalent recombinant LP2086
Pfizer announced that the FDA has accepted for review the Biologics License Application,BLA, for bivalent recombinant LP2086, the company’s vaccine candidate for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in 10 through 25 year olds. The FDA has also granted Priority Review designation for the BLA, providing an anticipated Prescription Drug User Fee Act, PDUFA, action date of February 14, 2015. “Pfizer has closely collaborated with the FDA since 2008 to develop our meningococcal B vaccine candidate with the intent to help prevent this devastating disease,” said Dr. Emilio Emini, senior vice president of Vaccine Research and Development for Pfizer. “Both the acceptance of Pfizer’s Biologics License Application today, and its Priority Review designation, are significant regulatory milestones that underscore the importance of our efforts to expedite the approval and subsequent availability of our meningococcal B vaccine for U.S. adolescents.”
17:02 EDTAGNPershing Square gives quarterly update on stakes
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14:28 EDTAGNAckman says Pershing, Valeant took no tender steps before buying Allergan shares
Bill Ackman made the statement to CNBC's Scott Wapner regarding his fund and Valeant's (VRX) pursuit of Allergan (AGN). Note that the Wall Street Journal reported earlier that the SEC is investigating Valeant and Pershing's pursuit of Allergan.
13:48 EDTAGNValeant, Pershing joint bid for Allergan being probed by SEC, WSJ says
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13:22 EDTAGNValeant, Pershing joint bid for Allergan being probed by SEC, DJ says
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12:01 EDTAMGNThird Point gives quarterly update on stakes
NEW STAKES: Rackspace (RAX), Finisar (FNSR), Amgen (AMGN), Ally Financial (ALLY), and AstraZeneca (AZN). INCREASED STAKES: Dollar General (DG) and Dow Chemical (DOW). DECREASED STAKES: FedEx (FDX), Hertz (HTZ), T-Mobile (TMUS) and Intrexon (XON). LIQUIDATED STAKES: Google Class A (GOOGL), Verizon (VZ) and Mondelez (MDLZ).
11:52 EDTAMGNThird Point discloses new stakes in Finisar, Amgen, Ally Financial
09:11 EDTSNYOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Kohl's (KSS), up 2.5%... Plug Power (PLUG), up 10%... Perrigo (PRGO), up 4.5%. HIGHER: Aruba Networks (ARUN), up 3% after shares upgraded at Stifel... KaloBios (KBIO), up 7.9% after publication shows EphA3 as target for anticancer therapy... Supernus (SUPN), up 4.4% after receiving FDA fast track designation for SPN-810. DOWN AFTER EARNINGS: Noodles & Company (NDLS), down 22%... Vipshop (VIPS), down 5.8%. LOWER: ExOne (XONE), down 10.7%, Voxeljet (VJET), down 6.6%, after earnings reports. Peers in the 3D space are lower as well, with Stratasys (SSYS) down 1% and 3D Systems (DDD) down 0.2%... Enphase Energy (ENPH), down 2.6% after filing to sell common stock for holders... InterMune (ITMN), down 3% after downgraded at Goldman following yesterday's advance on Bloomberg report that the company received takeover bids from Sanofi (SNY), Roche (RHHBY).
August 13, 2014
18:55 EDTAMGNOn The Fly: After Hours Movers
UP AFTER EARNINGS: Aspen Technology (AZPN), up almost 3% after reporting better than expected Q4 results and giving Q1 and FY15 guidance on its earnings conference call. ALSO HIGHER: Kindred Healthcare (KND), up more than 1% after Point72 reported a 5.1% passive stake in the company. DOWN AFTER EARNINGS: Cisco Systems (CSCO), down 1.2% after reporting Q4 results, giving Q1 guidance, and announcing that it is cutting 8% of its workforce... Noodles & Company (NDLS), down 21.2% after reporting Q2 results and "tempering" its FY14 outlook... Conatus Pharmaceuticals (CNAT), down 13.6% after reporting Q2 results and announcing it is deferring the results of its NAFLD/NASH clinical trial to 1Q15. ALSO LOWER: Amgen (AMGN), down 2.15% after announcing the Phase 3 Kyprolis FOCUS clinical trial did not meet its primary endpoint.
18:02 EDTMRKMerck provides statement on role of PNEUMOVAX 23 in updated ACIP recommendations
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17:08 EDTSNYSanofi Pastuer annnounces positive results from trial of Fluzone
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16:52 EDTMRKMerck confirms FDA approval of BELSOMRA
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16:32 EDTAGNAllergan acquires LiRIS program from TARIS Biomedical
Allergan and TARIS Holdings announced that Allergan has closed a transaction to acquire worldwide rights to TARIS Biomedical’s lead program, LiRIS, which is currently in Phase 2 trials for the treatment of interstitial cystitis / bladder pain syndrome. Allergan paid $67.5M in cash upfront, subject to certain adjustments and holdbacks. Allergan has also agreed to pay up to an aggregate of $295M in development milestone payments and up to an aggregate of $225M in commercial milestone payments. Prior to the closing of this transaction, TARIS spun out certain assets, including pipeline programs and intellectual property related to TARIS’ platform technology, to a new company funded by TARIS shareholders.
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