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News Breaks
January 21, 2014
07:12 EDTFRX, AZN, IRWDIronwood reports Q4 LINZESS net product sales $51M, as reported by Forest
Ironwood (IRWD) says LINZESS net product sales, as reported by Forest Laboratories (FRX) were $51M in Q4, an increase of approximately 48% quarter over quarter, and $118.8M for the year ended December 31, 2013. More than 220,000 LINZESS prescriptions were filled in Q4, resulting in more than 24% growth in total prescriptions quarter over quarter, and over 580,000 LINZESS prescriptions were filled in 2013, according to IMS Health. In 2013, more than 50,000 healthcare practitioners prescribed LINZESS, including approximately 90% of high prescribing gastroenterologists and approximately 70% of other high prescribing healthcare practitioners, primarily primary care physicians. Physician prescribing continues to increase month over month. Almirall, S.A., Ironwood’s European partner, continues to launch CONSTELLA in Europe. CONSTELLA is currently available to adult IBS-C patients in nine countries in Europe, including the United Kingdom and Germany. Ironwood and AstraZeneca (AZN) continue to enroll patients in a Phase III clinical trial of linaclotide in adult patients with IBS-C in China. The trial is expected to be completed in the first half of 2015. Astellas Pharma Inc. has completed enrollment in a Phase II double-blind, placebo-controlled, dose-ranging clinical trial of linaclotide in adult patients with IBS-C in Japan.
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August 19, 2014
07:01 EDTAZNDOJ closes investigation into PLATO Brilinta clinical trial, plans no action
AstraZeneca today announced that it has received confirmation from the United States Department of Justice that it is closing its investigation into PLATO, a clinical trial with BRILINTA tablets. The government is not planning any further action. Pascal Soriot, CEO, said: “We welcome the Department of Justice’s decision not to pursue further action. We have always had absolute confidence in the integrity of the PLATO trial and we are proud of the important benefit BRILINTA offers to patients around the world suffering from acute coronary syndrome. As one of AstraZeneca’s growth platforms, we remain committed to delivering the full potential of this important medicine.” As part of our continued commitment to advancing the science behind cardiovascular medicine, AstraZeneca has initiated a clinical trial program for BRILINTA, its largest program involving more than 80,000 patients worldwide.
August 18, 2014
07:57 EDTAZNCambridge Healthtech Institute to hold a summit
6th Annual Bioprocessing Summit to be held in Boston on August 18-22.
August 15, 2014
10:32 EDTIRWDHigh option volume stocks
High option volume stocks: BXR IRWD ACM CECO TCK JAH MNST AVB EDU DAR
August 14, 2014
17:32 EDTFRXIcahn Associates gives quarterly update on stakes
NEW STAKES: Gannett (GCI). INCREASED STAKES: Navistar (NAV), eBay (EBAY), and Icahn Enterprises (IEP). DECREASED STAKES: Netflix (NFLX). LIQUIDATED STAKES: Forest Laboratories (FRX).
12:01 EDTAZNThird Point gives quarterly update on stakes
NEW STAKES: Rackspace (RAX), Finisar (FNSR), Amgen (AMGN), Ally Financial (ALLY), and AstraZeneca (AZN). INCREASED STAKES: Dollar General (DG) and Dow Chemical (DOW). DECREASED STAKES: FedEx (FDX), Hertz (HTZ), T-Mobile (TMUS) and Intrexon (XON). LIQUIDATED STAKES: Google Class A (GOOGL), Verizon (VZ) and Mondelez (MDLZ).
August 13, 2014
08:31 EDTAZNAstraZeneca says Phase 3 trials of lesinurad for gout met primary endpoints
AstraZeneca announced top-line results from CLEAR1, CLEAR2 and CRYSTAL, the pivotal Phase III clinical trials investigating the potential of lesinurad, a selective uric acid re-absorption inhibitor, as a combination therapy for the treatment of patients with symptomatic gout. Lesinurad is an investigational agent that inhibits the URAT1 transporter, increasing uric acid excretion and thereby lowering serum uric acid. In the CLEAR1 and CLEAR2 trials, both lesinurad 200mg and 400mg in combination with allopurinol met the primary endpoint, with a statistically significant higher proportion of patients reaching the target sUA goal of <6.0mg/dL at month 6 compared to allopurinol alone. In the CRYSTAL trial, lesinurad 400mg in combination with febuxostat met the primary endpoint, with a statistically significant higher proportion of patients reaching the target sUA goal of <5.0mg/dL at month 6 compared to febuxostat alone. Although lesinurad 200mg did not achieve statistical significance at month 6, this dose in combination with febuxostat, was superior to placebo plus febuxostat at all other time points. Results from these Phase III clinical trials will be submitted to a scientific meeting later in 2014. The company is proceeding with preparation of regulatory submissions for lesinurad 200mg combination therapy.
August 12, 2014
05:58 EDTAZNStocks with implied volatility movement; P AZN
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August 7, 2014
06:13 EDTAZNDynavax says AZD1419 Phase 1 study met secondary endpoints
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August 6, 2014
09:19 EDTAZNShire, AstraZeneca, Smith & Nephew slump amid inversion fears, FT says
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