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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 22, 2014
16:11 EDTACTActavis confirms generic Neupro patent challenge
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14:19 EDTPFE, GSKViiV 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 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 EDTPFE, ACTActavis 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 EDTBMY, PFEBristol-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, MYL, TEVALannett 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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August 15, 2014
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
17:31 EDTACTZogenix says Actavis files ANDA for generic version of Zohydro ER
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17:08 EDTTEVASoros Fund Management gives quarterly update on stakes
NEW STAKES: CONSOL Energy (CNX), Google (GOOG), Level 3 (LVLT), Time Warner (TWC), and New Oriental (EDU). INCREASED STAKES: YPF SA (YPF), Apple (AAPL), Facebook (FB), AIG (AIG), and American Airlines (AAL). DECREASED STAKES: Teva (TEVA), Liberty Global (LBTYK), Barrick Gold (ABX), EQT (EQT), and Comcast (CMCSA). LIQUIDATED STAKES: FedEx (FDX), Monster Beverage (MNST), Google (GOOGL), Devon Energy (DVN), Marathon Petroleum (MPC).
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.”
14:13 EDTACTOmega Advisors gives quarterly update on stakes
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12:58 EDTTEVA, ACTJANA Partners gives quarterly update on stakes
NEW STAKES: Apache (APA), FMC Corp (FMC), Civeo (CVEO), PetSmart (PETM), and Charter Communications (CHTR). INCREASED STAKES: Actavis (ACT), AIG (AIG), Mallinckrodt (MNK), HD Supply (HDS), and American Capital (ACAS). DECREASED STAKES: Liberty (LVNTA), Oil States International (OIS), eBay (EBAY), Liberty Media (LMCA), and Liberty Interactive (LINTA). LIQUIDATED STAKES: Sirius XM (SIRI), Juniper (JNPR), Golar LNG (GLNG), Outerwall (OUTR), and Teva (TEVA).
12:46 EDTACTHayman Capital gives quarterly update on stakes
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August 13, 2014
16:19 EDTGSKOn The Fly: Closing Wrap
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13:13 EDTGSKInterMune exploring sale after bids from Sanofi, Roche, Glaxo, Bloomberg says
InterMune (ITMN) is working with its financial advisers Goldman Sachs (GS) and Centerview Partners to evaluate takeover bids it has received from Sanofi (SNY), Roche (RHHBY), GlaxoSmithKline (GSK) and Actelion (ALIOF), said Bloomberg, citing people with knowledge of the matter. The report noted that one of the sources said Sanofi has so far shown the most interest in a deal for InterMune, whose shares are up more than 13% to $51.56 following the first headlines from the report. Reference Link
August 12, 2014
17:07 EDTPFEPfizer announces results from Lyrica studies conducted in China
Pfizer announced top-line results from two placebo-controlled studies conducted in China with Lyrica in patients with postherpetic neuralgia, pain after shingles or PHN, and painful diabetic peripheral neuropathy, pDPN, respectively.The PHN Phase 4 study, A0081276, met its primary endpoint by demonstrating a statistically significant reduction in pain when compared to placebo. Separately, the pDPN Phase 3 study, A0081265, did not meet its primary endpoint, a statistically significant change in endpoint mean pain score relative to placebo. The PHN study was an eight-week, randomized, double-blind, multi-center, placebo-controlled, post-marketing study evaluating the efficacy, safety and tolerability of pregabalin 300mg/day in the treatment of subjects with PHN. For the primary efficacy parameter, change from baseline in weekly mean pain scores, a significant treatment difference of -0.71 points for pregabalin relative to placebo was observed. The safety profile in this study was consistent with the known profile for Lyrica.
09:35 EDTJNJActive equity options trading on open
Active equity options trading on open according to Track Data: AAPL GOOG C TSL EXAS BAC DNDN JNJ TSLA
07:55 EDTACTActavis recent weakness a buying opportunity, says Argus
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07:15 EDTGSKWHO says ethical to offer unproven interventions in light of Ebola outbreak
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06:18 EDTGSKGSK CEO faces pressure as company deals with weak sales, allegations, WSJ says
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August 11, 2014
12:57 EDTGSKGlaxoSmithKline facing new bribery allegations in Syria, Reuters reports
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08:47 EDTGSKGlaxo to conduct Ebola vaccine trials later this year, Guardian says
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07:36 EDTMYLMylan launches generic Xeloda tablets
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05:18 EDTNVSNovartis reports LCZ696 significantly reduced cardiovascular deaths
New data revealing the reduction in cardiovascular, or CV, deaths with Novartis' LCZ696 in patients with heart failure with reduced ejection fraction, or HF-REF, will be presented at the European Society of Cardiology, or ESC, Congress 2014. The 8,442 patient study, PARADIGM-HF, was specifically designed to see if LCZ696 could increase survival over and above what can be achieved with ACE-inhibitor enalapril in addition to current best treatment in HF-REF patients. In March the Data Monitoring Committee overseeing the study confirmed those given LCZ696 were significantly less likely to die from CV causes, leading to the trial being closed early. LCZ696 significantly reduced cardiovascular deaths in head to head study against enalapril, in addition to current best treatment, in patients with HF-REF. PARADIGM-HF is the largest heart failure study ever conducted and was stopped early in March due to compelling efficacy. LCZ696 was recently granted FDA Fast Track status and rolling submission expected to be complete by end of year.
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