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Stock Market & Financial Investment News

News For MEDI;PFE;CELG;PRXL;ACOR;NPSP;ALKS;AZN;TEVA From The Last 14 Days
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February 26, 2015
12:31 EDTPFEPfizer says CDC recommends serogroup B meningococcal vaccine for those at risk
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February 25, 2015
13:44 EDTCELGCelgene price target raised to $155 from $130 at Argus
Argus increased its price target on Celgene as the firm thinks the company is "well on its way" to meeting its growth targets. The firm thinks the company reported strong Q4 results and keeps a Buy rating on the shares.
08:30 EDTALKSAlkermes price target raised to $79 from $75 at Leerink
Leerink raised its price target for Alkermes shares to $79 to reflect probability-of-success weighted ALKS 8700 in multiple sclerosis revenue. The firm views the company's Q4 results as strong, but notes its 2015 outlook missed consensus due to higher than expected operating expenses. Leerink says the 2015 guidance reflects Alkermes' maturing pipeline. It keeps an Outperform rating on the stock.
08:05 EDTTEVATeva says FDA accepts CEP-33237 NDA for review
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06:19 EDTALKSAlkermes pipeline eases loss of pain program, says Citigroup
Citigroup says Alkermes' pipeline programs and the continued growth of its base business help moderate the disappointment of the discontinuation of novel pain program ALKS-7106. Citi lowered its price target for Alkermes shares to $83 from $85 and keeps a Buy rating on the stock.
05:57 EDTALKSUBS says remain on sidelines with respect to Alkermes
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February 24, 2015
10:06 EDTALKSHigh option volume stocks
High option volume stocks: CHGG LBTYK SMH RCAP NGLS OTEX TERP CNC ALKS AMT
09:02 EDTTEVATeva announces phase 2b study of TEV-48125 achieved endpoints
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08:56 EDTALKSOn The Fly: Pre-market Movers
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08:54 EDTALKSAlkermes 7106 halt overshadows Q4 beat, says Credit Suisse
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08:07 EDTPFEPfizer announces Trumenba studies met primary objectives
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08:04 EDTCELGCelgene reports Abraxane now reimbursed in Italy as first-line treatment
Celgene International Sŕrl, a wholly owned subsidiary of Celgene Corporation, announced that Italian authorities have issued a positive decision for NHS reimbursement of ABRAXANE -- paclitaxel formulated as albumin-bound nanoparticles, or nab-paclitaxel -- in combination with gemcitabine, for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas, or pancreatic cancer. The reimbursement decision has been published in the Italian Official Gazette no. 30, dated February 6, 2015.
07:33 EDTACORMaxim to hold a discussion
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07:31 EDTCELGRBC Capital to hold a conference
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07:06 EDTALKSAlkermes sees FY15 adjusted EPS 27c-40c, consensus 20c
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07:03 EDTALKSAlkermes reports Q4 EPS 11c, consensus 4c
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07:01 EDTALKSAlkermes announces phase 1 results for ALKS 7106, will not proceed to phase 2
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February 23, 2015
15:04 EDTTEVATeva announces publication of data on Phase III trials of reslizumab
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12:53 EDTAZNAnalysts debate potential for competing Salix takeover bid
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07:55 EDTAZNJefferies says other bidders may emerge for Salix
Jefferies says it could envision other bidders emerging for Salix (SLXP) and points out recent media reports have suggested Shire (SHPG) and Endo (ENDP) have considered making a bid for the company. It lists AstraZeneca (AZN) and Takeda as others who could have possible interest in Salix. The firm believes Valeant (VRX) could afford to pay more for Salix should other bidders emerge.
February 22, 2015
18:04 EDTNPSPShire completes acquisition of NPS Pharma
Shire (SHPG) announces the successful completion of the tender offer for all of the outstanding shares of NPS Pharmaceuticals (NPSP) and the subsequent acquisition of NPS Pharma.The tender offer expired at 12:00 midnight, New York City time, at the end of Friday, February 20, and was not extended. As of the expiration of the tender offer, a total of approximately 88,869,118 common shares of NPS Pharma had been validly tendered and not withdrawn pursuant to the tender offer, representing approximately 81.7% of the outstanding common shares of NPS Pharma. All shares that were validly tendered and not withdrawn pursuant to the tender offer were accepted for payment. After the acceptance of shares that were validly tendered and not withdrawn pursuant to the tender offer, Shire completed the acquisition of NPS Pharma today through a merger of one of Shire's subsidiaries with and into NPS Pharma. In connection with the merger, all common shares of NPS Pharma that were not accepted for payment in the tender offer (excluding any shares held by NPS Pharma as treasury stock (other than any shares held in an NPS Pharma benefit plan) and any shares with respect to which the holders have properly demanded appraisal rights in accordance with Delaware law) were converted into the right to receive $46.00 per share in cash, without interest and less any applicable withholding taxes, the same price that will be paid for shares accepted for payment in the tender offer. Following completion of the merger, NPS Pharma became a wholly owned subsidiary of Shire and NPS Pharma's shares ceased to be traded on NASDAQ.
February 20, 2015
16:03 EDTCELGOptions Update; February 20, 2015
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13:38 EDTACORLeerink specialty pharma analyst holds analyst/industry conference call
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10:33 EDTPFEBattleground update: AbbVie named top global pick at Jefferies
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10:31 EDTPFEPfizer announces FDA acceptance of NDA for Rapamune
Pfizer announced that the FDA has accepted for priority review a supplemental New Drug Application for RAPAMUNE for the treatment of lymphangioleiomyomatosis, a rare, progressive lung disease in women of childbearing age that is often fatal. With the Priority Review designation for the sNDA, Pfizer anticipates a decision in June of 2015 based on the anticipated Prescription Drug User Fee Act action date. The sNDA is based on results from the Multicenter International Lymphangioleiomyomatosis Efficacy and Safety of Sirolimus Trial. The MILES Trial included 89 LAM patients with moderate lung impairment who were randomized to receive RAPAMUNE or placebo for 12 months, followed by a 12 month observation period. In the trial, those treated with RAPAMUNE for one year experienced stabilization of lung function as measured by forced expiratory volume in one second.
09:38 EDTCELGActive equity options trading on open
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08:04 EDTTEVATeva to present new respiratory data at AAAAI
Teva Pharmaceutical Industries announced that four company-sponsored abstracts will be presented at the 2015 Annual Meeting of the American Academy of Allergy, Asthma and Immunology, or AAAAI, in Houston, Texas. Data to be presented include two replicate 52-week Phase III global studies of the company’s anti-IL5 monoclonal antibody, reslizumab, in patients with asthma and elevated blood eosinophils who were inadequately controlled on medium-to-high doses of inhaled corticosteroids with or without an additional controller. The data are scheduled for presentation on Monday, February 23 during an oral session titled “Asthma Therapy and Mechanisms.” Also to be presented are two Phase III studies of beclomethasone dipropionate 40mcg, which gained FDA approval in December 2014, and is now available for the treatment of nasal symptoms associated with allergic rhinitis in children 4-11 years of age. In addition, a dose-response study evaluating the safety and efficacy of fluticasone/salmeterol multidose dry-powder inhaler in patients 12 years of age and older with persistent asthma will be presented.
07:23 EDTAZN, PFEAbbVie replaces Pfizer as top global pharma pick at Jefferies
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07:08 EDTTEVA, AZNAmerican Academy of Allergy, Asthma and Immunology to hold annual meeting
2015 Annual Meeting of AAAAI is being held in Houston, Texas on February 20-24.
05:27 EDTCELGCelgene Revlimid approved by EC
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February 19, 2015
18:25 EDTPFEPiper Jaffray biotech analyst to hold analyst/industry conference call
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17:03 EDTTEVATeva to initiate Phase 2b TV-45070 clinical trial
Xenon Pharmaceuticals (XENE) announced that its development and commercialization partner Teva Pharmaceutical (TEVA) will initiate a Phase 2b clinical trial of TV-45070 in patients with post-herpetic neuralgia, or PHN. The Phase 2b clinical trial in PHN will be a randomized, double-blind, placebo controlled, multi-site study to evaluate the efficacy and safety of TV-45070 in patients with PHN. The study will include three treatment groups to receive doses of 4% or 8% of TV-45070 or placebo, dosed twice daily. Approximately 330 patients will be enrolled in the study. Patients will be stratified into treatment groups based on their R1150W status, a genetic pain biomarker believed to be related to pain susceptibility. The primary endpoint of this study is the change from baseline to week 4 in the numeric rating scale, or NRS, scores. Secondary endpoints include additional pain measurement scores at specified daily time points, the percentage of patients with greater than 30% and greater than 50% improvement in pain scores, quality of life measurements and adverse events measurements. The first patient is anticipated to be dosed in March, and the anticipated completion date for the Phase 2b clinical trial is mid-2016.
14:49 EDTPFEWalgreens selected by Pfizer as one of pharmacies to dispense Ibrance
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07:12 EDTNPSP, PFEWharton Health Care Club to hold a conference
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February 18, 2015
16:00 EDTCELGOptions Update; February 18, 2015
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10:05 EDTCELGOn The Fly: Analyst Initiation Summary
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09:38 EDTCELGCelgene reports FDA expands indication for Revlimid combo
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09:37 EDTCELGOption volume leaders on open
Option volume leaders: AAPL TSLA TWTR CELG APO NFLX AXP APA LNKD C GILD according to Track Data.
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.
06:47 EDTCELGCelgene initiated with a Buy at Canaccord
Target $156.
February 17, 2015
17:16 EDTAZNActavis confirms temporary injunction related to generic Pulmicort RESPULES
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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.
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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07:04 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
16:32 EDTAZNActavis launches generic Pulmicort RESPULES
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10:28 EDTPFEPfizer announces FDA acceptance for review of NDA for ALO-02
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08:23 EDTACOR, TEVAPiper Jaffray biotech/healthcare analysts hold analyst/industry conference call
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08:19 EDTCELG, PFE, AZNAckman noncommittal on McDonald's rumors, Bloomberg reports
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05:38 EDTCELGCelgene volatility increases on wide price movement
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February 12, 2015
15:12 EDTPFEJ&J Remicade appeal process could take years to resolve, says Wells Fargo
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10:00 EDTACOROn The Fly: Analyst Initiation Summary
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08:27 EDTTEVATeva announces $1B debt tender offer
Teva Pharmaceutical Industries has commenced tender offers to purchase for cash for a combined aggregate purchase price of up to $1B of the following series of notes issued by finance subsidiaries of Teva and guaranteed by Teva: 6.150% Senior Notes due 2036 issued by Teva Pharmaceutical Finance Company, LLC; 3.650% Senior Notes due 2021 issued by Teva Pharmaceutical Finance Company B.V. and 3.650% Senior Notes due 2021 issued by Teva Pharmaceutical Finance IV B.V.; 2.950% Senior Notes due 2022 issued by Teva BV; and 2.400% Senior Notes due 2016 issued by Teva BV. Teva is engaging in the offers to lower its overall interest expense. Teva expects to fund the offers through a future offering of Eurobonds or other senior notes, borrowings under its existing credit facilities and/or other available cash. The offers are not subject to any financing condition.
08:22 EDTACORAcorda Therapeutics initiated with a Buy at MLV & Co.
Target $58.
07:33 EDTPFEHospira not announcing FY15 projections due to recent merger argreement
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06:09 EDTACORAcorda Therapeutics sees FY15 Ampyra revenue $405M-$420M
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06:08 EDTACORAcorda Therapeutics reports Q4 Ampyra revenue $109.9M
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06:07 EDTACORAcorda Therapeutics reports Q4 non-GAAP EPS 46c, consensus 14c
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