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News Breaks
June 4, 2014
04:55 EDTZIOP, ZIOP, PFE, PFE, ALKS, ALKS, TEVA, TEVA, SNY, SNY, GSK, GSK, MRK, MRK, RHHBY, RHHBY, BAYRY, BAYRY, DRNA, DRNA, KBIO, KBIO, ABBV, ABBVBoston Biotech Conference to hold a conference
Boston CEO Conference to be held in Boston on June 4-5.
News For ABBV;KBIO;DRNA;BAYRY;RHHBY;MRK;GSK;SNY;TEVA;ALKS;PFE;ZIOP From The Last 14 Days
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February 19, 2015
05:31 EDTRHHBYExelixis announces acceptance of NDA for Genentech cobimetinib
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05:26 EDTRHHBYFDA grants Genentech cobimetinib priority review for combination use
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February 18, 2015
07:45 EDTTEVAEagle Pharmaceuticals price target raised to $37 from $30 at Cantor
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07:13 EDTTEVAEagle Pharmaceuticals target raised to $43 from $25 at William Blair
William Blair raised its price target for Eagle Pharmaceuticals (EGRX) to $43 saying the company's agreement with Teva (TEVA) removes a major overhang on the stock. William Blair says the deal is a significant positive for Eagle since it removes litigation risk and moves the company immediately into profitability. It keeps an Outperform rating on the stock.
February 17, 2015
18:06 EDTABBVPaulson & Co gives quarterly update on stakes
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15:36 EDTPFETianyin JCM plans for FDA certification process
Tianyin Pharmaceutical (TPI) updated on the business and development at its Jiangchuan Macrolide Facility, or JCM, active pharmaceutical ingredients operation. In addition to JCM's certification at India, along with other international clients located at Bangladesh, Philippines and Iran on import status, TPI plans for FDA certification process at its JCM facility in order to service international clients such as Pfizer's (PFE) and their subsidiaries in China, the company said. "This is expected to translate to further demand for JCM's macrolide API business in both the domestic and international markets," Tianyin stated.
11:38 EDTSNYGenzyme reports publication of ENGAGE registration study results
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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 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
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.
09:07 EDTABBVDeutsche Bank biotech analyst holds an analyst/industry conference call
Biotech Analyst Karnauksas discusses AbbVie's product pipeline in an Analyst/Industry conference call to be held on February 13 at 10 am.
08:23 EDTBAYRY, GSK, TEVAPiper Jaffray biotech/healthcare analysts hold analyst/industry conference call
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08:19 EDTGSK, PFE, MRKAckman 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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06:13 EDTABBVShire says $1.6B break fee from AbbVie is not taxable, Financial Times reports
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