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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.
News For IRWD;FRX;AZN From The Last 14 Days
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October 16, 2014
15:10 EDTIRWDAmerican College of Gastroenterology to hold annual meeting
ACG Annual Scientific Meeting 2014 to be held in Philadlephia, PA on October 17-22.
08:02 EDTIRWDIronwood announces initiation of Phase II linaclotide trial
Ironwood Pharmaceuticals (IRWD) announced the initiation of a Phase II clinical trial evaluating linaclotide for the treatment of adults suffering from opioid-induced constipation. Data are expected in the second half of 2015. The clinical trial is being conducted jointly by Ironwood and Actavis plc (ACT), Ironwood’s co-development and co-promotion partner for linaclotide in the United States. Linaclotide is a guanylate cyclase-C agonist approved by the FDA for the treatment of adults with irritable bowel syndrome with constipation or chronic idiopathic constipation. Linaclotide is not currently approved for the treatment of OIC. The randomized, double-blind, placebo-controlled, multi-site Phase II clinical trial is expected to enroll approximately 240 adult patients with chronic, non-cancer pain who have been receiving a stable dose of an opioid analgesic and suffer from constipation, defined as fewer than three spontaneous bowel movements per week. Patients will be randomized to receive 145 mcg of linaclotide, 290 mcg of linaclotide, or placebo for eight weeks. The primary endpoint of the trial is an increase in SBM frequency. Additionally, a number of secondary endpoints and exploratory analyses intended to inform future development plans are included in the study design.
October 15, 2014
10:48 EDTAZNShire tanks with AbbVie calling board meeting over merger
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October 14, 2014
11:23 EDTAZNBIND Therapeutics and The Conference Forum hold a conference
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October 13, 2014
10:08 EDTAZNOn The Fly: Analyst Upgrade Summary
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09:21 EDTAZNOn The Fly: Pre-market Movers
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07:53 EDTAZNAstraZeneca upgraded to Buy from Hold at Jefferies
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05:27 EDTAZNAstraZeneca upgraded to Buy from Hold at Jefferies
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October 9, 2014
08:10 EDTAZNAstraZeneca reports Phase IIb study of benralizumab met primary endpoint
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October 7, 2014
07:48 EDTAZNSalix reinstated with a Buy at Jefferies
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October 6, 2014
07:32 EDTAZNAstraZeneca confirms AHA, ACC updated guideline
AstraZeneca confirmed that the American Heart Association and American College of Cardiology have updated the guideline for the management of patients with non–ST-elevation acute coronary syndromes. The guideline supports differentiation among currently available P2Y12 inhibitors, including ticagrelor, clopidogrel, and prasugrel, for these patients. BRILINTA is now preferred over clopidogrel for the management of NSTE-ACS patients who undergo an early invasive or ischemia-guided strategy or those who receive a coronary stent. This is the first time the AHA and ACC have recommended one P2Y12 over another in the treatment of acute coronary syndrome. The approved Prescribing Information for BRILINTA includes information about the approved uses for BRILINTA. BRILINTA has two Boxed WARNINGS, one for bleeding risk and the other for aspirin dose and reduced BRILINTA effectiveness. The Boxed WARNING on BLEEDING RISK states, like other antiplatelet agents, BRILINTA can cause significant, sometimes fatal, bleeding.

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