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Stock Market & Financial Investment News

News Breaks
April 2, 2013
05:55 EDTGLW, GLW, GSK, GSK, PFE, PFE, BAYRY, BAYRY, LLY, LLY, SNY, SNY, MNTA, MNTA, ONXX, ONXX, AMGN, AMGN, MRK, MRK, CBST, CBST, BIIB, BIIB, SHPG, SHPGBoston Biotech Conferences to host a conference
BD Biotech Conference is being held in Boston on April 2-3.
News For GLW;BIIB;CBST;MRK;AMGN;ONXX;MNTA;SNY;LLY;BAYRY;PFE;GSK;SHPG From The Last 14 Days
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August 20, 2014
08:04 EDTGSKPOZEN announces U.S. rights for Treximet acquired by Pernix Therapeutics
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08:03 EDTPFEBristol-Myers Pfizer to present new Eliquis data
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August 19, 2014
16:46 EDTSNYFDA approves Genzyme Cerdelga capsules
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05:11 EDTAMGNGamida Cell announces investment, option agreement with Novartis
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August 18, 2014
17:37 EDTLLYFDA grants tentative approval for Lilly, Boehringer Basaglar insulin
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17:25 EDTAMGNAmgen announces AMG 416 study met its primary and all secondary endpoints
Amgen announced that a second placebo-controlled Phase 3 study evaluating AMG 416 for the treatment of secondary hyperparathyroidism, SHPT, in patients with chronic kidney disease,CKD, receiving hemodialysis, met its primary and all secondary endpoints. "The results from this second Phase 3 study help to confirm that AMG 416 could become an important new treatment option for dialysis patients with secondary hyperparathyroidism," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Despite the variety of options available for the treatment of this disease, an unmet need remains for an intravenous therapy that can be administered along with hemodialysis. We look forward to sharing results of a head-to-head study evaluating AMG 416 compared to cinacalcet next year."
11:41 EDTCBST, LLY, PFECubist rises after report sparks takeover interest speculation
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09:43 EDTCBSTCubist may receive takeover interest, Bloomberg reports
Cubist Pharmaceuticals' (CBST) focus on bacterial infections could attract takeover interest, Bloomberg reports in its Real M&A column. Reference Link
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 EDTSHPG, PFE, MRKCambridge Healthtech Institute to hold a summit
6th Annual Bioprocessing Summit to be held in Boston on August 18-22.
August 15, 2014
18:35 EDTBIIBBiogen PLEGRIDY approved in U.S. for treatment of multiple sclerosis
Biogen Idec announced that the FDA has approved PLEGRIDY, a new treatment for people with relapsing forms of multiple sclerosis, or RMS. PLEGRIDY is dosed once every two weeks and can be administered subcutaneously with the PLEGRIDY PEN, a new, ready-to-use autoinjector, or a prefilled syringe. The FDA approval of PLEGRIDY is based on results from one of the largest pivotal studies of beta interferon conducted, ADVANCE, which involved more than 1,500 MS patients.
07:01 EDTBIIBIsis Pharmaceuticals earns $2M from advancement of ISIS-SMN from Biogen
Isis Pharmaceuticals (ISIS) announced that it has earned a $2M milestone payment from Biogen (BIIB) related to the advancement of the ongoing open-label extension study of ISIS-SMNRx in children with spinal muscular atrophy.
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.
06:34 EDTGSKLawyer says GSK connected investigators to not appeal ruling, Reuters says
Defense lawyer Zhai Jian said GlaxoSmithKline connected corporate investigator Peter Humphrey and his American wife are not aiming to appeal a Chinese court's prison sentence ruling, according to Reuters, citing comments from Jian. Reference Link
August 14, 2014
19:41 EDTGLWApple considering sapphire glass in upcoming iPhone, smartwatch, WSJ reports
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17:16 EDTSHPGPaulson & 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.”
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).
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