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Stock Market & Financial Investment News

News For GSK;PFE From The Last 14 Days
Check below for free stories on GSK;PFE the last two weeks.
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August 29, 2014
10:17 EDTPFEInnoPharma announces FDA approval of generic Dacogen
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August 28, 2014
13:17 EDTPFEPfizer, Protalix announce FDA approves ELELYSO pediatric indication
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08:55 EDTPFEOn The Fly: Pre-market Movers
HIGHER: Digital Ally (DGLY), up 16% after announcing order from Michigan State Police for over $1.1M... EnteroMedics (ETRM), up 12.4% after reporting three-year data from Maestro RC system... Repros (RPRX), up 0.8% after Androxal achieves superiority in both co-primary endpoints in a study... Synthetic Biologics (SYN), up 2.7% after Pfizer (PFE) was granted FDA Fast Track designation for its investigational Clostridium difficile vaccine candidate. Synthetic Biologics announced earlier this week that SYN-004, the company's lead anti-infective product candidate for the prevention of the effects of C. difficile, will be presented in October... Signet (SIG), up 3.9% after Q2 revenue tops consensus. DOWN AFTER EARNINGS: Abercrombie & Fitch (ANF), down 5.7%... Guess (GES), down 8.3%... Frontline (FRO), down 7%. ALSO LOWER: Williams-Sonoma (WSM), down 10.9% after downgraded at Morgan Stanley following the company's Q2 earnings report... GT Advanced (GTAT), down 2% after downgraded at Raymond James... Sungy Mobile (GOMO), down 20.1% following earnings report, CFO resignation, downgrade of stock at Oppenheimer... Genesco (GCO), down 7.7% after cutting fiscal year forecast.
08:01 EDTPFEPfizer says FDA grants fast track designation to C-difficile vaccine candidate
Pfizer announced that the U.S. Food and Drug Administration thas granted Fast Track designation to the company’s investigational Clostridium difficile vaccine candidate PF-06425090. Currently in Phase 2 clinical development, the vaccine candidate is designed to prevent C. difficile-associated disease, which can include life-threatening diarrhea and pseudomembranous colitis. The FDA’s Fast Track approach is a process designed to facilitate the development and expedite the review of new drugs and vaccines intended to treat or prevent serious conditions and address an unmet medical need.
07:34 EDTGSKGSK could start testing Ebola vaccine on humans next week, Bloomberg reports
GlaxoSmithKline could begin tests of its experimental vaccine for Ebola on humans as early as next week in the U.S., Bloomberg reports. GSK is developing the vaccine with the Vaccine Research Center of the National Institutes of Health, and they have received FDA approval to begin the Phase 1 trial, Michael Kurilla, director of the Office of Biodefense, Research Resources and Translational Research, says. Reference Link
August 27, 2014
17:49 EDTGSKGSK, Shire rumored to be interested in Tekmira, Daily Mail says
GlaxoSmithKline (GSK) and Shire (SHPG) are rumored to be interested in a bid for Tekmira (TKMR), reports Daily Mail. Tekmira could be a value to potential suitors, capitalized at approximately GBP 400M and the company could cost over GBP 1B in a takeover, Daily Mail adds. Reference Link
09:53 EDTPFEOn The Fly: Analyst Initiation Summary
Bristol-Myers (BMY) initiated with a Hold at Deutsche Bank... ASML (ASML) initiated with a Hold at Stifel... Akamai (AKAM) initiated with an Outperform at RW Baird... Concur (CNQR) initiated with a Neutral at DA Davidson... CyrusOne (CONE) initiated with a Neutral at Citigroup... Eli Lilly (LLY) initiated with a Buy at Deutsche Bank... Garmin (GRMN) initiated with a Neutral at RW Baird... Merck (MRK) initiated with a Hold at Deutsche Bank... NetSuite (N) initiated with a Buy at DA Davidson... Oracle (ORCL) initiated with a Neutral at DA Davidson... Oxford Industries (OXM) initiated with a Buy at Wunderlich... Pfizer (PFE) initiated with a Buy at Deutsche Bank... ServiceNow (NOW) initiated with a Buy at DA Davidson... Workday (WDAY) initiated with a Neutral at DA Davidson... MannKind (MNKD) initiated with a Buy at Jefferies... STMicroelectronics (STM) initiated with an Underperform at Credit Suisse... Kirkland's (KIRK) initiated with an Outperform at Barrington.
08:03 EDTGSKGlaxoSmithKline receives FDA approval for sNDA for Promacta/Revolade
Ligand Pharmaceuticals Incorporated (LGND) announced that its partner GlaxoSmithKline (GSK) has received approval of a supplemental New Drug Application for the once-daily use of Promacta/Revolade in patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. SAA is a blood disorder where the bone marrow fails to make enough red blood cells, white blood cells and platelets.2 Eltrombopag, an oral thrombopoietin receptor agonist, works by helping to induce proliferation and differentiation of bone marrow stem cells to increase production of blood cells.
06:42 EDTPFEPfizer initiated with a Buy at Deutsche Bank
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August 26, 2014
14:42 EDTGSKGlaxoSmithKline receives FDA approval of additional Promacta indication
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08:47 EDTGSKGenetic Technologies says NC court denies GlaxoSmithKline motion to dismiss
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08:01 EDTPFEPfizer, Merck to collaborate on study evaluating anti-cancer combination regimen
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August 25, 2014
12:19 EDTGSKOn The Fly: Midday Wrap
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10:40 EDTGSKBiotechs rise after InterMune acquired by Roche
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06:29 EDTPFEPfizer mulls possible AstraZeneca offer options, FT says
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August 22, 2014
14:19 EDTPFE, GSKViiV Healthcare receives FDA approval for HIV-1 treatment Triumeq
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August 21, 2014
13:32 EDTPFEBristol-Myers, Pfizer announce approval of Eliquis for treatment of DVT, PE
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09:54 EDTPFEPotential Pfizer, AstraZeneca deal seen around year-end, Reuters says
Investors and analysts see Pfizer (PFE) making another attempt to acquire AstraZeneca (AZN) around year-end, even though talks between the two can resume on August 26 per British takeover rules, Reuters reports. Reference Link
08:02 EDTPFEPfizer initiates U.S. EAP for palbociclib.
Pfizer announced that the company has initiated a multi-center, open-label expanded access program in the U.S. for palbociclib. Through the program, palbociclib is being made available for use in combination with letrozole for post-menopausal women with hormone receptor positive human epidermal growth factor receptor 2 negative advanced breast cancer for whom letrozole is considered appropriate therapy.
07:55 EDTPFEActavis volatility expected to move on Pfizer considering new target report
Actavis (ACT) volatility is expected to move on Pfizer (PFE) considering other overseas alternatives, Bloomberg reports. Overall option implied volatility of 27 is near its 26-week average of 31 according to Track Data, suggesting decreasing price movement.
07:47 EDTPFEPfizer looking at new targets, including Actavis, Bloomberg reports
While it weighs another attempt to acquire AstraZeneca (AZN), Pfizer is considering other overseas alternatives, including Actavis (ACT), Bloomberg reports, citing people familiar with the matter. Pfizer prefers to reach a deal with AstraZeneca, and a move on another company is unlikely "anytime soon," Bloomberg adds, citing its sources. Shares of Actavis are rising 3%, or $6.65, to $230.01 in pre-market trading, while AstraZeneca is up 2% to $72.59. Reference Link
August 20, 2014
15:35 EDTGSKGlaxoSmithKline receives FDA approval for Arnuity Ellipta in the U.S.
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11:44 EDTGSKMylan completes second bidding round for GSK prescription portfolio, WSJ says
Mylan (MYL), TPG Capital, Advent International, KKR (KKR), Warburg Pincus and a few Indian prescription manufacturers have completed the second round of bidding for GlaxoSmith Kline's (GSK) portfolio of mature medications, according to The Wall Street Journal, citing people familiar with the sales process. GSK noted that it aims to sell a portfolio of drug brands in the U.S. and EU with yearly sales of approximately $1.66B. Reference Link
08:30 EDTGSKPernix closes acquisition of Treximet
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08:29 EDTGSKPernix Therapeutics to host conference call
Conference call to discuss acquisition of Treximet will be held on August 20 at 9 am. Webcast Link
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 18, 2014
11:41 EDTPFECubist rises after report sparks takeover interest speculation
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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 EDTPFECambridge Healthtech Institute to hold a summit
6th Annual Bioprocessing Summit to be held in Boston on August 18-22.
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