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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
Check below for free stories on PFE;ACT;JNJ;NVS;TEVA;MYL;GNK;BMY;GSK the last two weeks.
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August 31, 2014
14:04 EDTPFE, JNJ, GSK, NVSWorldwide 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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12:50 EDTBMY, PFE, NVSEuropean 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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15:29 EDTMYLMylan receives FDA approval for generic lamivudine, aidovudine
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12:23 EDTNVSNovartis 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 EDTNVS, PFEInnoPharma announces FDA approval of generic Dacogen
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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.
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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11:22 EDTTEVA, MYLMylan ANDA for three times per week generic Copaxone accepted by FDA for filing
Mylan (MYL) announced that its abbreviated new drug application for a three times per week Glatiramer Acetate Injection 40 mg/mL has been accepted for filing by the U.S. Food and Drug Administration. This product is the generic version of Teva's (TEVA) Copaxone 40 mg/mL, which is indicated for the treatment of patients with relapsing forms of multiple sclerosis. Mylan believes it is one of the first companies to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity in the U.S. upon final FDA approval. Copaxone 40 mg/mL had U.S. sales of approximately $411.5M for the 12 months ending June 30, 2014, according to IMS Health.
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
07:21 EDTTEVATeva recalls batch of generic Parkinson's drug in U.S., Globes reports
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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 EDTPFE, BMYOn 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 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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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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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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August 22, 2014
16:11 EDTACTActavis confirms generic Neupro patent challenge
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14:19 EDTGSK, PFEViiV Healthcare receives FDA approval for HIV-1 treatment Triumeq
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12:39 EDTBMYThese 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
08:02 EDTMYLMylan launches first generic Klor-Con Extended-release tablets
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August 21, 2014
15:16 EDTACT, TEVADEA restricts painkiller drug prescriptions to curb abuse, WSJ reports
The Drug Enforcement Agency, or DEA, will reclassify hydrocodone combination painkiller drugs and place them in the category of medical substances that have the highest potential for harm in an attempt to curb the widespread abuse of the drugs, according to The Wall Street Journal. The rescheduling of the drugs will take effect in 45 days and result in people being able to obtain the drug for only 90 days without obtaining a new prescription. Major manufacturers of these drugs include Teva Pharmaceutical (TEVA), Mallinckrodt (MNK), AbbVie (ABBV), and Actavis (ACT). Reference Link
13:32 EDTPFE, BMYBristol-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 EDTACT, PFEActavis 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 EDTPFE, ACTPfizer 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
07:38 EDTACTSupernus announces paragraph IV Abbreviated NDA filing for Trokendi XR
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05:42 EDTJNJIllumina 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 EDTMYL, GSKMylan 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
11:33 EDTMYLMylan into second round of bidding for GSK drug portfolio, WSJ reports
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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 EDTPFE, BMYBristol-Myers Pfizer to present new Eliquis data
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08:02 EDTBMYBristol-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
11:44 EDTMYLMylan launches generic Precedex Injection
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11:18 EDTACTDepomed announces favorable ruling in Gralise case
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10:32 EDTACTDepomed higher after favorable ruling in Gralise case
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07:26 EDTACTActavis confirms positive results from RECLAIM pivotal Phase III studies
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05:11 EDTNVS, TEVAGamida Cell announces investment, option agreement with Novartis
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August 18, 2014
11:41 EDTJNJ, PFECubist rises after report sparks takeover interest speculation
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10:06 EDTACT, TEVA, MYLLannett surges after upbeat Q4, FY14 outlook
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08:50 EDTTEVATeva management to meet with JPMorgan
Meeting to be held in Boston on August 20 hosted by JPMorgan.
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 EDTPFE, BMYCambridge Healthtech Institute to hold a summit
6th Annual Bioprocessing Summit to be held in Boston on August 18-22.
07:35 EDTNVSApricus Biosciences launches topical ED treatment in Germany
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