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News Breaks
March 26, 2013
06:32 EDTGNK, NVS, PFE, GSK, MYL, JNJ, BMY, TEVA, ACTSome justices seem skeptical about payments to generic drug firms, NY Times says
Several Supreme Court justices seemed skeptical about the practice of brand name pharmaceutical companies paying generic companies to keep their cheaper drugs off the market for a longer time, according to The New York Times. Some of the justices appeared to be interested in issuing a narrow ruling in the case they are hearing regarding the issue that would not create a precedent, the newspaper added. Reference Link
News For PFE;ACT;JNJ;NVS;TEVA;MYL;GNK;BMY;GSK From The Last 14 Days
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February 17, 2015
13:52 EDTACTEarnings Preview: Actavis near 52-week high ahead of Q4 earnings report
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13:18 EDTACTOmega Advisors gives quarterly update on stakes
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10:01 EDTPFECVS says PCSK9 inhibitors could cost system $150B annually
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08:47 EDTTEVABioTime provides update on Cell Cure's product development, partnering
BioTime (BTX) and its subsidiary Cell Cure Neurosciences provided an update on Cell Cure’s product development and partnering activities. On February 16, Cell Cure opened the clinical trial of OpRegen titled “Phase I/IIa Dose Escalation Safety and Efficacy Study of Human Embryonic Stem Cell-Derived Retinal Pigment Epithelium Cells Transplanted Subretinally in Patients with Advanced Dry-Form Age-Related Macular Degeneration with Geographic Atrophy” at Hadassah University Medical Center in Jerusalem, Israel. Patient enrollment is expected to begin shortly. OpRegen consists of animal product-free retinal pigment epithelial cells with high purity and potency. On October 31, 2014, the FDA cleared Cell Cure's Investigational New Drug application to initiate the clinical trial of OpRegen in patients with the severe form of age-related macular degeneration with geographic atrophy.The Phase I/IIa clinical trial, will evaluate three different dose regimens of OpRegen. Following transplantation, the patients will be followed for 12 months at specified intervals, to evaluate the safety and tolerability of the product. Following the initial 12 month period, patients will continue to be monitored at longer intervals for an additional period of time. A secondary objective of the clinical trial will be to examine the ability of transplanted OpRegen to engraft, survive, and moderate disease progression in the patients. In addition to thorough characterization of visual function, a battery of ophthalmic imaging modalities will be used to quantify structural changes and rate of GA expansion. Cell Cure also announced that the option granted to Teva (TEVA) under a Research and Exclusive Option Agreement of October 7, 2010 to license-in rights to its OpRegen product has expired without having been exercised by Teva. Cell Cure will therefore be continuing the clinical development of OpRegen on its own and pursuing discussions with other potential strategic partners, including those that have already indicated interest in participating in development and commercialization of the product. Cell Cure also announced that US patent No. 8,956,866 relating to a proprietary method of manufacturing RPE cells is expected to issue on February 17. This patent combined with other patents and patent applications in the BioTime family of companies provides significant patent protection for this novel therapeutic modality for AMD.
08:39 EDTTEVATeva deal small but important, says BMO Capital
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08:35 EDTTEVATeva announces launch of generic Lovenox and Zyvox in U.S.
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07:38 EDTGSKGlaxo replaces head of struggling U.S. drug unit, Bloomberg reports
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07:04 EDTJNJGTx names Robert Wills as executive chairman
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07:04 EDTTEVATeva, Eagle enter license agreement for EP-3102
Teva Pharmaceutical Industries (TEVA) and Eagle Pharmaceuticals (EGRX) announce that the companies have entered into an exclusive license agreement for EP-3102, Eagle’s bendamustine hydrochloride rapid infusion product for the treatment of chronic lymphocytic leukemia and indolent B-cell non-Hodgkin lymphoma. Teva will be responsible for all U.S. commercial activities for the product including promotion and distribution. Eagle has responsibility for obtaining all regulatory approvals, conducting post-approval clinical studies, if required, and initially supplying drug product to Teva. As part of the agreement, Teva will waive its orphan drug exclusivities for NHL and CLL with respect to EP-3102, which should allow the product to come to market more quickly. Under the terms of the exclusive license agreement, Eagle will receive an upfront cash payment of $30M and is eligible to receive up to $90M in additional milestone payments. In addition, Eagle will receive double-digit royalties on net sales of the product, assuming FDA approval. The companies will also settle the pending patent infringement action between them.
February 13, 2015
17:52 EDTACTThird Point gives quarterly update on stakes
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16:32 EDTACTActavis launches generic Pulmicort RESPULES
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14:03 EDTBMYBristol-Myers DMD treatment granted orphan status
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11:31 EDTNVSNovartis says heart failure medicine LCZ696 granted FDA piority review
Novartis announced that the U.S. FDA has granted priority review designation to LCZ696, an investigational medicine for the treatment of heart failure with reduced ejection fraction. The designation accelerates the review of therapies that offer a significant improvement in the safety or effectiveness of the treatment, prevention or diagnosis of a serious condition[4]. For LCZ696 this reduces the total review time from 12 to 8 months, meaning the FDA could make a decision on approval in August 2015. The New Drug Application was submitted under the agency's Fast Track program and is based on results from the landmark PARADIGM-HF study, the largest ever conducted in heart failure, which showed LCZ696 was superior to ACE-inhibitor enalapril on key endpoints, including significantly reducing the risk of CV death or heart failure hospitalization. Patients' reports of how well they felt were significantly better with LCZ696 than enalapril, whilst maintaining an acceptable safety profile. In the EU the Committee for Medicinal Products for Human Use has granted accelerated assessment to LCZ696.
10:28 EDTPFEPfizer announces FDA acceptance for review of NDA for ALO-02
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10:00 EDTGSKOn The Fly: Analyst Upgrade Summary
Today's noteworthy upgrades include: Ametek (AME) upgraded to Outperform at RW Baird... Ascena Retail (ASNA) upgraded to Buy from Hold at KeyBanc... Cabela's (CAB) upgraded to Buy from Neutral at DA Davidson... CoreSite Realty (COR) upgraded to Overweight from Equal Weight at Stephens... Cytokinetics (CYTK) upgraded to Overweight from Neutral at Piper Jaffray... DTS, Inc. (DTSI) upgraded to Outperform at Cowen... Dr Pepper Snapple (DPS) upgraded to Market Perform from Underperform at Wells Fargo... Elizabeth Arden (RDEN) upgraded to Outperform from Market Perform at BMO Capital... EnLink Midstream (ENLC) upgraded to Buy from Hold at Wunderlich... GlaxoSmithKline (GSK) upgraded to Buy from Sell at UBS... Great-West Lifeco (GWLIF) upgraded to Buy from Hold at TD Securities... Himax (HIMX) upgraded to Buy from Neutral at Chardan... Mallinckrodt (MNK) upgraded to Overweight from Neutral at JPMorgan... Medical Properties upgraded to Outperform from Sector Perform at RBC Capital... Microchip (MCHP) upgraded to Buy from Hold at Drexel Hamilton... Orbitz (OWW) upgraded to Neutral from Sell at Goldman... Plains GP Holdings (PAGP) upgraded to Overweight from Equal Weight at Stephens... SanDisk (SNDK) upgraded to Buy from Hold at Drexel Hamilton... SkyWest (SKYW) upgraded to Buy from Hold at Deutsche Bank... Stage Stores (SSI) upgraded at Sterne Agee... Tractor Supply (TSCO) upgraded to Buy from Hold at Argus... Valero (VLO) upgraded to Conviction Buy from Neutral at Goldman... Watsco (WSO) upgraded to Overweight from Equal Weight at Stephens.
08:32 EDTACTActavis to divest Pharmatech to TPG
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08:23 EDTTEVA, GSK, JNJ, NVSPiper Jaffray biotech/healthcare analysts hold analyst/industry conference call
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08:19 EDTGSK, PFE, BMYAckman noncommittal on McDonald's rumors, Bloomberg reports
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06:33 EDTGSKGlaxoSmithKline upgraded to Buy from Sell at UBS
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05:09 EDTJNJStocks with implied volatility movement; JNJ NUGT
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