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Stock Market & Financial Investment News

News For TEVA;NPSP;CELG;AZN;ACOR;PFE;ALKS;PRXL;MEDI From The Last 14 Days
Check below for free stories on TEVA;NPSP;CELG;AZN;ACOR;PFE;ALKS;PRXL;MEDI the last two weeks.
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July 16, 2014
07:04 EDTPFEPfizer says primary endpoint met in Phase 3 study of BeneFIX
Pfizer announced the positive results of a Phase 3 study comparing a prophylaxis regimen of BeneFIX Coagulation Factor IX 100 IU/kg once-weekly to on-demand treatment in people with moderately severe to severe hemophilia B. The top-line results of the study showed that the primary study endpoint was met and hemophilia B patients taking once-weekly BeneFIX showed a statistically significant reduction in the annualized bleeding rate relative to on-demand treatment with BeneFIX. In the study, the median ABR value, a commonly used measure of efficacy for prophylaxis regimens in hemophilia, was 2.0 for the prophylaxis regimen, compared to 33.6 for the on-demand regimen, representing a 94% decrease in bleeding rates. The mean ABR value was 3.6 for the prophylaxis period, compared to 32.9 for the on-demand treatment, which represents a reduction of 89%. Study results also showed that prophylaxis treatment significantly reduced both spontaneous and traumatic ABR compared to on-demand treatment with BeneFIX. In addition to meeting the primary endpoint, the secondary study endpoints showed that none of the 1,254 prophylaxis infusions administered during the study were associated with a less than expected therapeutic effect occurrence, which was defined as a spontaneous bleed occurring within 48 hours of a prophylaxis infusion. These results are preliminary, top-line data and are subject to additional analyses. Complete results from this study will be submitted for presentation at upcoming medical congresses and submitted for publication in a peer-reviewed journal.
July 15, 2014
11:13 EDTTEVAPerrigo retreats after analyst sees limited potential buyers
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10:56 EDTCELGFed calls small cap social media, biotech valuations 'stretched'
The Board of Governors of the Federal Reserve in its Monetary Policy Report dated today said valuation metrics in "some sectors" appear substantially stretched, "particularly those for smaller firms in the social media and biotechnology industries, despite a notable downturn in equity prices for such firms early in the year." A later part in the document reads, "Equity valuations of smaller firms as well as social media and biotechnology firms appear to be stretched, with ratios of prices to forward earnings remaining high relative to historical norms." The specific targeting of sectors by the Fed seems to be having an impact on stocks in the social media and biotech spaces. Shares of Yelp (YELP) are down over 5% to $67.51, while Twitter (TWTR) and Facebook (FB) are each down 2%. Celgene (CELG) and Amgen (AMGN) are leading the biotech space lower with pullbacks of greater than 1%.
10:33 EDTCELGFacebook, Twitter slip following cautious valuation comments from Fed
Shares of a number of companies in the social media and biotech industries moved lower following the circulation of cautious comments about their stock valuations that were included in the Federal Reserve's latest Monetary Policy Report. WHAT'S NEW: In the report, presented by the Board of Governors of the Federal Reserve and signed on behalf of the governors by Chair Janet Yellen, the central bank wrote that some broad equity price indexes have increased to all-time highs in nominal terms since the end of 2013, but that valuation measures for the overall market in early July were "generally at levels not far above their historical averages." However, the Fed's report also cautioned that valuation metrics in some sectors do appear substantially "stretched," particularly those for smaller firms in the social media and biotechnology industries, despite a notable downturn in equity prices for such firms early in the year. As support for its assessment, the Fed noted that ratios of prices to forward earnings for "smaller firms as well as social media and biotechnology firms" remain "high relative to historical norms." PRICE ACTION: Following the circulation of the comments in the Fed report, shares of Facebook (FB) are down 88c, or 1.3%, to $67.02, Twitter (TWTR) is down 24c, or 0.6%, to $38.07 and LinkedIn (LNKD), is down 21c, or 0.1%, to $159.57. Shares of some biotechnology companies including Celgene (CELG) and Amgen (AMGN) also ticked lower following the circulation of the comments from the Fed's report.
06:28 EDTTEVAActivist shareholder says Teva to appoint new chairman, Reuters says
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July 14, 2014
08:04 EDTTEVATeva announces FDA acceptance of NDA filing for albuterol MDPI
Teva Pharmaceuticals Industries announced that the U.S. Food and Drug Administration has accepted for review the company’s new drug application for albuterol multi-dose dry-powder inhaler, an investigational breath-actuated dry-powder inhaler for the treatment or prevention of bronchospasm in patients 12 years of age and older with reversible obstructive airway disease; and for the prevention of exercise-induced bronchospasm in patients 12 years of age and older. The NDA filing includes data from eight clinical studies that evaluated the safety and efficacy of albuterol MDPI in adults and adolescents with asthma and exercise-induced bronchospasm. The NDA for albuterol MDPI has been accepted by the FDA for standard review, with a FDA Regulatory Action expected in March 2015.
July 11, 2014
07:38 EDTALKSHouse Energy & Commerce Committee to hold a hearing
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07:28 EDTNPSPNPS Pharmaceuticals attractive ahead of launch updates, says Leerink
Leerink calls shares of NPS Pharmaceuticals "very attractive" ahead of the Gattex launch updates on the company's Q2 and Q3 earnings conference calls. Leerink says its survey of 34 gastroenterologists who treat 739 short bowel syndrome patients indicated continued robust increases in Gattex uptake during the second half of 2014 and through 2016. It reiterates an Outperform rating on NPS with a $40 price target.
July 9, 2014
16:25 EDTCELGCelgene reports 11.9% passive stake in GlobeImmune
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11:57 EDTCELGCelgene shares higher despite missing primary endpoint in Otezla trial
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09:35 EDTCELGActive equity options trading on open
Active equity options trading on open according to Track Data: AAPL AA FB AMZN TSLA TWTR MU NFLX GG CELG
09:13 EDTCELGOn The Fly: Pre-market Movers
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07:15 EDTTEVATeva, others fined $583.4M by EU regulators, Reuters says
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07:04 EDTCELGCelgene says OTEZLA did not achieve primary endpoint in Phase III trial
Celgene Corporation announced results of its phase III POSTURE study evaluating OTEZLA, the company’s oral, selective inhibitor of phosphodiesterase 4, in patients with active ankylosing spondylitis. The OTEZLA arms did not achieve statistically significant improvement versus the placebo arm for the primary endpoint, the percentage of patients who achieve an ASAS 20 response at week 16. However, in a prespecified analysis, meaningful efficacy was observed at Week 24 in a large subset of patients with early-stage disease. Evaluation of the efficacy results is ongoing. An independent data monitoring committee recommended that the study proceed unchanged, based on an assessment of the safety and efficacy data at week 24. According to the protocol, magnetic resonance imaging data will be collected in a subgroup of subjects at week 52 and at additional time points, and radiographs will be taken on all study patients at week 104 and at additional time points. The safety and tolerability data observed in the POSTURE study are consistent with previously reported phase II data in ankylosing spondylitis, as well as six phase III studies of OTEZLA in psoriatic arthritis or psoriasis. No new safety signals were observed. The evaluation of safety and efficacy in the treatment arms is ongoing and the results of the study will be presented at an upcoming medical meeting. These results are from an investigational phase III study. OTEZLA is not approved for the treatment of patients with ankylosing spondylitis in any country.
07:04 EDTALKSAlkermes announces notice of allowance for four pipeline candidates
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06:49 EDTTEVAGeneric drug prices have risen significantly, NY Times says
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06:49 EDTPFEPfizer given dismissal of U.S. investor class action before trial, Reuters says
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06:45 EDTACORAcorda Therapeutics to initiate Phase 3 clinical trial for dalfampridine
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July 8, 2014
07:17 EDTAZNLeerink raises immuno-oncology market forecast to $36B
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07:03 EDTTEVAEagle Pharmaceuticals receives orphan drug designation for bendamustine HCl
Eagle Pharmaceuticals (EGRX) announced that the FDA has granted orphan drug designation to bendamustine hydrochloride, a ready-to-dilute concentrate solution for injection that will be administered by infusion over 10 minutes after dilution in 50mL of sodium chloride or a saline / dextrose mixture, for the treatment of chronic lymphocytic leukemia and indolent B-cell non-Hodgkin’s lymphoma. Pursuant to the orphan drug designation, Eagle is eligible to receive tax incentives and Prescription Drug User Fee Act fee savings, and believes it may receive seven years of marketing exclusivity. The currently marketed bendamustine HCI product, Treanda, which is manufactured by Cephalon, Inc., a wholly-owned subsidiary of Teva Pharmaceutical Industries (TEVA), is a lyophilized powder requiring reconstitution and dilution in 500mL of saline or a sodium chloride / dextrose mixture before administration over 30 minutes for CLL and 60 minutes for NHL.
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