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Stock Market & Financial Investment News

News For MRK;PFE;GSK;JNJ;BMY;NVS;SHPG;ABT;CELG;SNY From The Last 14 Days
Check below for free stories on MRK;PFE;GSK;JNJ;BMY;NVS;SHPG;ABT;CELG;SNY the last two weeks.
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September 2, 2014
15:00 EDTJNJWright Medical hip suit weakness would be buying opportunity, says Brean Capital
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13:58 EDTSNYRegeneron expected to receive priority review at Piper Jaffray
Piper Jaffray expects Regeneron (REGN) and Sanofi (SNY) will receive priority review for alirocumab via the priority review voucher recently acquired from BioMarin (BMRN). Piper says potential approval of the drug is likely by mid-2015 and it reiterates an Overweight rating on Regeneron with a $382 price target.
10:29 EDTNVSHigh option volume stocks
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09:41 EDTCELGActive equity options trading on open
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08:35 EDTSNYIntrexon enters into ECC with Sanofi subsidiary to develop APIs
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08:19 EDTCELGCelgene GED301 drug has positive risk/reward ratio in near-term, says Bernstein
Bernstein believes that the upcoming trial of Celgene's GED0301 drug for Crohn's disease has very little risk in the near-term, while the presentation of results of a study of the drug next month should be positive for the stock. The firm thinks that the drug could emerge as a popular combination partner for other systemic drugs in patients who continue to have disease symptoms. Bernstein is more cautious about the drug's outlook starting in 2016 but keeps a $103 price target and Outperform rating on the stock.
07:59 EDTNVSElbit Imaging subsidiary announces Gamida Cell completed execution of agreements
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07:21 EDTSNYRegeneron data positive, says RBC Capital
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07:12 EDTBMYCredit Suisse names its Top U.S. Pharmaceutical picks for 2H
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07:10 EDTBMYAlder Biopharmaceuticals regains worldwide rights to clazakizumab
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07:01 EDTNVSNovartis volatility expected to move on heart failure drug LCZ696 study
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September 1, 2014
13:48 EDTPFEProtalix to host conference call
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11:13 EDTGSKCipla introduces generic version of GSK's Advair in Europe, Reuters says
India's Cipla has launched a generic version of GlaxoSmithKline's anti-asthma inhaler Advair in Germany and Sweden, says Reuters. Reference Link
August 31, 2014
14:22 EDTSNYSanofi, Regeneron announce results from four Phase 3 ODYSSEY trials
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14:04 EDTGSK, NVS, PFE, JNJ, MRKWorldwide Business Research to hold a conference
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13:47 EDTNVSNovartis heart failure drug LCZ696 shows superiority to enalapril in study
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13:41 EDTCELGCitigroup to hold a conference
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13:23 EDTABTGoldman to hold a conference
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12:50 EDTNVS, BMY, PFE, SNY, ABTEuropean Society of Cardiology to hold a conference
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August 29, 2014
16:21 EDTNVSOn The Fly: Closing Wrap
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12:23 EDTSNY, NVSNovartis drug data to be presented this weekend
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12:18 EDTNVSOn The Fly: Midday Wrap
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11:07 EDTNVSHigh option volume stocks
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10:51 EDTNVSUnited Therapeutics jumps after court rules generic will infringe
United Therapeutics (UTHR) alleged patent infringement against Sandoz, a unit of Novartis (NVS), related to the latter's filing for approval of a generic version of United Therapeutics' remodulin drug. A New Jersey court ruled today that Sandoz's proposed ANDA product will infringe the claims of UTC's '117 patent, according to a court filing. Following the court ruling, shares of United Therapeutics are up 15% to $105.39 in morning trading.
10:17 EDTPFE, NVSInnoPharma announces FDA approval of generic Dacogen
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10:06 EDTSNYSanofi unit treatment of Fabry's disease granted orphan status
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10:04 EDTNVSNovartis hematopoietic support for ALL patients granted orphan status
Novartis' hematopoietic stem and progenitor cells expanded ex-vivo with a low molecular weight aryl hydrocarbon receptor antagonist was granted orphan designation as a hematopoietic support in patients with acute lymphoblastic leukemia, or ALL, the FDA stated. Reference Link
08:46 EDTNVSNovartis has a conference call hosted by JPMorgan
JPMorgan Analyst Vosser hosts a conference call with CEO Joe Jimenez on September 5 at 8 am.
08:18 EDTSNYPerrigo among companies showing interest in Omega Pharma, Bloomberg says
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August 28, 2014
17:42 EDTJNJJ&J begins sales process for its medical device unit Cordis, WSJ says
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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.
08:40 EDTNVSPositive data on Novartis LCZ696 could raise sales outlook, says Leerink
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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 EDTGSK, SHPGGSK, 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 EDTPFE, BMY, MRKOn 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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06:42 EDTMRKMerck initiated with a Hold at Deutsche Bank
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06:42 EDTBMYBristol-Myers initiated with a Hold at Deutsche Bank
Target $52.
05:44 EDTBMYBristol-Myers Daklinza approved by EC
Bristol-Myers announced that the European Commission, or EC, has approved Daklinza for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of chronic hepatitis C virus, or HCV, infection in adults. Daklinza, when used in combination with sofosbuvir, is an all-oral, interferon-free regimen that provided cure rates of up to 100% in clinical trials, including patients with advanced liver disease, genotype 3 and those who have previously failed treatment with protease inhibitors. Daklinza is the first NS5A complex inhibitor approved in the European Union and will be available for use in combination with other medicinal products, providing a shorter treatment duration compared to 48 weeks of treatment with interferon- and ribavirin-based regimens. The approval allows for the marketing of Daklinza in all 28 Member States of the EU. The marketing authorization for Daklinza follows an accelerated assessment by the Committee for Medicinal Products for Human Use, a designation that is granted to new medicines of major public health interest.
August 26, 2014
14:42 EDTGSKGlaxoSmithKline receives FDA approval of additional Promacta indication
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11:20 EDTCELGCelgene added to short term buy list at Deutsche Bank
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09:35 EDTCELGActive equity options trading on open
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08:47 EDTGSKGenetic Technologies says NC court denies GlaxoSmithKline motion to dismiss
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08:01 EDTMRK, PFEPfizer, Merck to collaborate on study evaluating anti-cancer combination regimen
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August 25, 2014
16:13 EDTMRKOn The Fly: Closing Wrap
Stocks began the session in positive territory and proceeded to tack on gains throughout the morning. Despite a disappointing report on new home sales in July, the S&P surpassed the 2,000 level for the first time before noon. The market pared its gains shortly after the milestone was reached and drifted for the remainder of the session on light volume, as trading activity may be restrained all week ahead of the Labor Day weekend. ECONOMIC EVENTS: In the U.S., the Chicago Fed's National Activity index jumped to 0.39 in July from an upwardly revised 0.21 in June. Markit's preliminary August services PMI came in at 58.5, which was down from a prior reading of 60.8 but above the 58.0 consensus projection. New home sales dropped 2.4% to a 412K rate in July, missing expectations for them to have risen to a 430K annualized rate. COMPANY NEWS: Shares of InterMune (ITMN) surged $19.05, or 35.41%, to $72.85 after the company agreed to be acquired by Roche (RHHBY) for $74.00 per share in an all-cash transaction. The deal announcement comes less than two weeks after Bloomberg reported that Roche, along with big pharma peers Sanofi (SNY) and GlaxoSmithKline (GSK), had made takeover bids for the smaller drugmaker. A number of other biotech companies gained following the deal announcement, including bigger names like Gilead (GILD) and Celgene (CELG) and smaller ones such as Achillion Pharmaceuticals (ACHN) and Receptos (RCPT)... Burger King (BKW) shares rose $5.29, or 19.51%, to $32.40 after the company confirmed it is in talks regarding a potential strategic transaction with Canadian donut chain Tim Hortons (THI). Shares of Tim Horton's trading in New York also gained $11.88, or 18.91%, to $74.72 following the confirmation of news first reported by The Wall Street Journal. MAJOR MOVERS: Among the other notable gainers was Advaxis (ADXS), which advanced 75c, or 23.08%, to $4.00 after announcing it has entered into a clinical trial collaboration agreement with Merck (MRK). Also rising were shares of Comtech (CMTL), which jumped $1.70, or 4.84%, to $36.81 after Reuters said the company is working with Citigroup to explore a potential sale. Among the noteworthy losers was Chinese internet and software company Qihoo 360 Technology (QIHU), which fell $7.88, or 7.74%, to $93.87 despite reporting second quarter earnings and revenue that beat analysts' estimates. Also lower were shares of GrubHub (GRUB), which fell $3.60, or 8.42%, to $39.16 after filing to sell 10M shares of common stock. INDEXES: The Dow gained 75.65, or 0.44%, to 17,076.87, the Nasdaq rose 18.80, or 0.41%, to 4,557.35, and the S&P 500 advanced 9.54, or 0.48%, to 1,997.94.
12:19 EDTCELG, GSK, SNYOn The Fly: Midday Wrap
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11:48 EDTSNYSanofi and Regeneron co-host a conference call
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10:40 EDTGSK, SNY, CELGBiotechs rise after InterMune acquired by Roche
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09:11 EDTMRKOn The Fly: Pre-market Movers
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08:27 EDTJNJJanssen Affiliate Cilag acquires Covagen, terms not disclosed
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07:03 EDTJNJVIVUS acquires patents from Janssen Pharmaceuticals
VIVUS (VVUS) announced the acquisition of a group of patents from Janssen Pharmaceuticals (JNJ) covering uses of topiramate as monotherapy and in combination with other pharmaceutical agents to treat a variety of medical conditions. Janssen has agreed to dismiss the lawsuit it brought against VIVUS on August 22, 2014 in the U.S. District Court for the District of Delaware. VIVUS will pay a one-time upfront fee and a royalty to Janssen on Qsymia product sales for an assignment of these topiramate-related patents owned by Janssen. VIVUS has an option to buy out the royalty for a predetermined amount.
06:29 EDTPFEPfizer mulls possible AstraZeneca offer options, FT says
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05:17 EDTMRKAdvaxis, Merck enter clinical trial collaboration agreement
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August 22, 2014
14:19 EDTGSK, PFEViiV Healthcare receives FDA approval for HIV-1 treatment Triumeq
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12:39 EDTSNY, BMYThese five companies will benefit from increased ALS awareness, MarketWatch says
A recent surge in funding for Lou Gehrig's disease, or ALS, caused by the Ice Bucket challenge that is widespread on social media outlets, will benefit five pharmaceutical companies that are involved in the development of a cure for ALS, according to MarketWatch. The companies that are or have been involved in developing a treatment for ALS include Biogen Idec (BIIB), Avanir Pharmaceuticals (AVNR), Isis Pharmaceuticals (ISIS), Sanofi (SNY), and Bristol-Myers Squibb (BMY), MarketWatch added. Reference Link
August 21, 2014
13:32 EDTBMY, PFEBristol-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
05:42 EDTSNY, JNJIllumina announces strategic partnership with AstraZeneca, Sanofi, Janssen
Illumina (ILMN) announced it has formed collaborative partnerships with leading pharmaceutical companies to develop a universal next-generation sequencing, or NGS,-based oncology test system. The system will be used for clinical trials of targeted cancer therapies with a goal of developing and commercializing a multi-gene panel for therapeutic selection, resulting in a more comprehensive tool for precision medicine. Initial strategic partners include AstraZeneca (AZN), Janssen Biotech, a Johnson & Johnson (JNJ) company, and Sanofi (SNY). Illumina is working with the strategic partners to develop assays that detect and measure multiple variants simultaneously to support partners’ clinical trials, with the objectives of securing regulatory agency approvals and test commercialization. In parallel, Illumina is working with key thought leaders to set standards for NGS-based assays in routine clinical oncology practice, as well as to define regulatory frameworks to enable this new testing paradigm. Together, Illumina and its strategic partners aim to transition from single-analyte companion diagnostics to panel-based assays that select for “companion therapeutics.”
August 20, 2014
15:35 EDTGSKGlaxoSmithKline receives FDA approval for Arnuity Ellipta in the U.S.
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12:06 EDTNVSNovartis treatment for pigmented villonodular synovitis gets orphan designation
According to a post on the FDA's website, Novartis' recombinant human monoclonal antibody of the IgG1 kappa class against human macrophage colony-stimulating factor received orphan designation. Reference Link
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 EDTBMY, PFEBristol-Myers Pfizer to present new Eliquis data
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08:02 EDTBMY, CELGBristol-Myers, Celgene enter collaboration agreement for OPDIVO, ABRAXANE
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05:17 EDTNVSNovartis provides drug candidate compounds to TB Alliance
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August 19, 2014
16:46 EDTSNYFDA approves Genzyme Cerdelga capsules
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09:38 EDTCELGActive equity options trading on open
Active equity options trading on open according to Track Data: AAPL GILD TSLA CELG VLO VZ FB HD
07:33 EDTCELGCelgene announces publication of REVLIMID combination results
Celgene announced that results of a study evaluating the combination of REVLIMID with rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate and prednisone in untreated diffuse large b-cell lymphoma were published online ahead of print in the Journal of Clinical Oncology. In a phase II, open label, single arm study, 64 patients with newly diagnosed, untreated, stage II-IV CD20 positive DLBCL received 25 mg of lenalidomide on days 1-10 with standard dose R-CHOP every 21 days for six cycles. All patients received pegfilgrastim on day two of each cycle and aspirin prophylaxis throughout. The primary endpoint was event-free survival with secondary endpoints of progression free survival and overall survival. A one-stage binomial design was used to assess the efficacy and tolerability of REVLIMID with R-CHOP. Of the 64 patients enrolled, 60 were eligible for response evaluation. In these patients, the overall response rate was 98% with 80% achieving a complete response. The 24-month EFS, which was identical to PFS, and OS rates were 59% and 78%, respectively. The company said, "This study demonstrated that the addition of lenalidomide to conventional R-CHOP resulted in similar PFS rates and OS rates between sub-types. This is intriguing as patients with the non-GCB phenotype have traditionally experienced poorer outcomes. The results of this study support further evaluation of this regimen in this sub-type of DLBCL.”
05:11 EDTNVSGamida Cell announces investment, option agreement with Novartis
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