Key Developments: Abbott Laboratories (ABT)
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17 May 2013
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Latest Key Developments (Source: Significant Developments)
Abbott Laboratories Shares Scorched By Kidney Drug Failure-Reuters
Reuters reported that Abbott Laboratories said its partner, Reata Pharmaceuticals, was discontinuing a late-stage trial of their potential blockbuster treatment for chronic kidney disease and diabetes based on safety concerns raised by an independent safety committee. An independent data-monitoring committee found excess serious adverse events and mortality in patients taking the oral anti-inflammatory drug, Abbott said in a regulatory filing. Full Article
Abbott Laboratories Narrows FY 2012 EPS Guidance
Abbott Laboratories narrowed fiscal 2012 earnings per share (EPS) guidance to a range $5.06 to $5.08 from $5.00 to $5.10. Including specified items, projected earnings per share under GAAP would be $3.83 to $3.85 for the full-year 2012. According to I/B/E/S Estimates, analysts were expecting the Company to report EPS of $5.06 for fiscal 2012. Full Article
Abbott Laboratories Oral Hepatitis C Regimen Cure Rate High-Study-Reuters
Reuters reported that an all oral regimen of experimental hepatitis C medicines developed by Abbott Laboratories led to high cure rates in both new patients and those for whom prior treatment failed, according to initial results from a midstage study. After 12 weeks of treatment with three Abbott direct-acting antiviral medicines plus the older drug ribavirin, 99% of previously untreated patients and 93% of those who did not respond to older drugs achieved a sustained virologic response (SVR), which is considered cured, according to available data from a brief summary, or abstract, of the study. Abbott Laboratories will present much more detail on the Phase II study involving data from more patients at the American Association for the Study of Liver Diseases (AASLD) meeting in Boston. Based on the results, Abbott Laboratories said it would test its three drugs, each of which attacks the virus using a different approach, both with and without ribavirin in a large Phase III program aimed at gaining approval for the treatment. Full Article
U.S. Judge Accepts Abbott Laboratories Misbranding Settlement-Reuters
Reuters reported that Abbott Laboratories must pay $700 million in fines and other costs for illegal marketing of its drug Depakote, in line with a previously announced settlement, the U.S. Justice Department said on Tuesday. The Company said in May it would plead guilty to a misdemeanor violation of misbranding and pay $1.6 billion to state and federal authorities. Abbott marketed Depakote for conditions including depression, anxiety and drug withdrawal while the drug did not have government approval for those uses, prosecutors said. A federal judge in Virginia sentenced Abbott at a hearing on Tuesday as part of the broader settlement. The settlement includes a $500 million criminal fine, $198.5 million in lost profits and a $1.5 million payment to Virginia state officials. Abbott will be on probation for five years. That is in addition to an $800 million civil settlement with federal and state officials and $100 million to U.S. states to resolve consumer protection matters. Full Article
Abbott Laboratories Declares Quarterly Dividend
Abbott Laboratories announced that it declared a quarterly common dividend of $0.51 per share. The cash dividend is payable November 15, 2012, to shareholders of record at the close of business on October 15, 2012. Full Article
Abbott Laboratories To Collaborate With Astellas In CMV Vaccine Trial
Abbott Laboratories announced that it has signed an agreement to collaborate with Astellas Pharma Global Development in a Phase 3 clinical trial for ASP0113 (TransVax), an investigational vaccine licensed from Vical Incorporated for preventing cytomegalovirus (CMV) reactivation in transplant patients. Under the agreement, Abbott's RealTime CMV assay, which is performed on the Abbott m2000 System and intended for investigational use only, will be used to monitor patients for CMV viral load in order to assess the vaccine's efficacy. Viral load is a measure of the severity of a viral infection or the amount of active virus in the blood. A herpes virus, CMV infects half of all adults by age 40 and is the most common viral infection in transplant recipients. After primary infection, CMV establishes lifelong latency without causing symptoms. The virus is often dormant in those who are healthy but can cause illness in immunocompromised people, such as those undergoing stem cell or organ transplants. Hematopoietic cell transplant patients and other individuals with depressed immune systems are vulnerable to severe complications from CMV infection, including CMV disease and death. Full Article
Abbott Laboratories' HUMIRA (Adalimumab) Secures Approval In Europe For Expanded Treatment Of Crohn's Disease
Abbott Laboratories announced that the European Commission (EC) has approved HUMIRA (adalimumab) for the treatment of moderately active Crohn's disease (CD) in adult patients who have had an inadequate response to conventional therapy. HUMIRA has been approved for severely active CD in adults in the European Union (EU) since 2007. The approval is supported by four Phase 2/3 clinical trials which evaluated the use of HUMIRA to induce and maintain clinical remission in adult patients with moderately to severely active CD. Full Article
Abbott Laboratories's Omnilink Elite Vascular Balloon-Expandable Stent System Receives FDA Approval For Treatment Of Iliac Artery Disease
Abbott Laboratories announced that the U.S. Food and Drug Administration (FDA) approved the Omnilink Elite Vascular Balloon-Expandable Stent System for the treatment of iliac artery disease, a form of peripheral artery disease (PAD) that affects the lower extremities. Iliac artery disease can progress to where patients experience chronic pain and reduced ability to walk, potentially leading to permanent disability. The FDA approval is supported by positive clinical data from the MOBILITY (Omnilink Elite or Absolute Pro Stent Used in the Iliac Artery) study. The MOBILITY study demonstrated that Omnilink Elite is safe and effective, including when used for patients who are difficult-to-treat due to complex disease resulting from severely calcified lesions. Full Article
Abbott Laboratories' HUMIRA (adalimumab) Approved In Europe For Treatment Of Non-radiographic Axial Spondyloarthritis (nr-axSpA)
Abbott Laboratories announced that the European Commission (EC) has approved HUMIRA (adalimumab) for the treatment of adults with severe axial spondyloarthritis (axSpA) who have no X-ray evidence of structural damage. HUMIRA is the first and only approved medication available for non-radiographic axSpA patients (nr-axSpA). This approval marks the eighth indication for HUMIRA in the European Union since the product's first approval in 2003. AxSpA, which includes ankylosing spondylitis (AS) and nr-axSpA, can be a debilitating condition that primarily presents with chronic back pain and stiffness, and can also be accompanied by the presence of arthritis, inflammation in the eye and/or gastrointestinal tract. People with nr-axSpA can have similar signs and symptoms as AS, including chronic pain and loss of function, but do not have X-ray evidence of structural damage. Non-radiographic axSpA is most often seen in younger individuals in their most productive point in life and can go unrecognized for years. Full Article
Abbott Laboratories Confirms FY 2012 EPS Guidance
Abbott Laboratories announced that it is confirming its ongoing earnings-per-share guidance for fiscal 2012 of $5.00 to $5.10, reflecting another year of expected strong performance. . According to I/B/E/S Estimates, analysts were expecting the Company to report EPS of $5.04 for fiscal 2012. Full Article
Abbvie says Chief Scientific Officer John Leonard to retire
- AbbVie Inc's chief scientific officer will be retiring in the next few months and will be involved in the process of naming a successor, the pharmaceutical company said in a regulatory filing on Friday.
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