Key Developments: Abbott Laboratories (ABT)
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24 May 2013
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$37.48
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1,170,581
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$31.64
Latest Key Developments (Source: Significant Developments)
Abbott Laboratories Announces CE Mark For Coronary Drug Eluting Stent
Abbott Laboratories announced CE Mark in Europe for the XIENCE Xpedition 48 Everolimus Eluting Coronary Stent System, the first-of-its-kind treatment for long blockages in the vessels that supply blood to the heart due to coronary artery disease (CAD). XIENCE Xpedition 48 leverages the design and clinical outcomes of the XIENCE family of drug eluting stents in a 48 mm length. Abbott continues to offer physicians more options for the treatment of patients with complex coronary artery disease and is the only manufacturer to offer a coronary drug eluting stent greater than 38 mm in length. XIENCE Xpedition 48 is the latest in a long history of stent innovations pioneered by Abbott, which was the first company to offer physicians size-specific metallic stents for use in small and large vessels of the heart. Studies indicate that physicians choose to use multiple shorter length stents to meet the challenges of treating long blockages - or lesions - in as many as 30% of interventional heart procedures, as conventional stent sizes may not always fully cover the lesion. Full Article
Russia Rejects Abbott Laboratories Plan To Buy Petrovax-Reuters
Reuters reported that Russia's government commission on foreign investment has turned down U.S. group Abbott Laboratories' request to buy Russian vaccine maker Petrovax, the head of Russia's competition regulator said. Igor Artemyev, head of the Federal Anti-Monopoly Service (FAS) said the decision was made in order to protect the country's national security interests and took into account international experience. Abbott Laboratories applied for permission to buy Petrovax last year and according to media reports the deal was valued at $280 million. Full Article
Abbott Laboratories Announces FDA Approval And U.S. Launch Of TECNIS Toric Intraocular Lens For Cataract Patients
Abbott Laboratories announced that the TECNIS Toric 1-Piece intraocular lens (IOL) has received U.S. Food and Drug Administration (FDA) approval and is launching in the United States for the treatment of cataract patients with pre-existing corneal astigmatism. Corneal astigmatism is a condition where the curvature of the cornea is uneven, preventing light rays from focusing clearly on the retina, resulting in blurred vision. Intraocular lenses are implanted in a patient's eye after the removal of the natural lens that has become clouded by a cataract. Full Article
Abbott Laboratories Issues Q2 2013 EPS Guidance In Line With Analysts' Estimates; Reaffirms FY 2013 EPS Guidance
Abbott Laboratories announced that for second quarter of 2013 it expects ongoing earnings per share (EPS) in the range of $0.43 to $0.45. The Company forecasts net specified items for the second quarter of 2013 of approximately $0.16 per share. Including these net specified items, projected earnings per share from continuing operations under Generally Accepted Accounting Principles (GAAP) would be $0.27 to $0.29. Specified items are primarily associated with intangible amortization expense and previously announced cost reduction initiatives. The Company reaffirmed fiscal 2013 EPS guidance and expects EPS in the range of $1.98 to $2.04. The Company forecasts net specified items for fiscal 2013 of approximately $0.59 per share. Including these net specified items, projected earnings per share from continuing operations under Generally Accepted Accounting Principles (GAAP) would be $1.39 to $1.45 for fiscal 2013. According to I/B/E/S Estimates, analysts were expecting the Company to report EPS of $0.44 for second quarter of 2013 and EPS of $2.01 for fiscal 2013. Full Article
Pfizer Inc, Novartis AG And Abbott Laboratories Weigh Bids For Brazil's Ache Laboratorios Farmaceuticos-Reuters
Reuters reported that at least three of the world's top drugmakers are bidding for Brazil's Ache Laboratorios Farmaceuticos in an auction that may value the group at more than $5 billion. Pfizer Inc, Novartis AG and Abbott Laboratories are all weighing second-round bids to acquire the company. Bids are due in the second half of April. Privately owned Ache is attractive to drug companies looking to increase their footprint in the growing market of Latin America. GlaxoSmithKline Plc showed early interest but has dropped out of the running. Full Article
FDA Advisory Committee Votes Favorably on Laboratories' Minimally Invasive MitraClip Device for Patients with Significant Mitral Regurgitation Who Are Too High Risk for Surgery
Abbott Laboratories announced that the U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee has voted by majority (Yes: 5, No: 3) that the benefits of treatment with the MitraClip device outweigh its risks in patients with significant symptomatic mitral regurgitation (MR) who have been determined by a cardiac surgeon to be too high risk for open mitral valve surgery and in whom existing co-morbidities would not preclude the expected benefit from correction of the MR. Abbott's MitraClip device, which received CE Mark in 2008 and is commercially available in Europe and other international markets, is an investigational device in the United States. The device is delivered to the heart through the femoral vein, a blood vessel in the leg, and is designed to reduce MR by clipping together a portion of the leaflets of the mitral valve to allow the heart to more efficiently pump blood. Full Article
FDA Staff Does Not Recommend Approval Of Abbott Laboratories' Heart Device-Reuters
Reuters reported that Staff reviewers for the U.S. Food and Drug Administration did not recommend approval of Abbott Laboratories' implantable heart device MitraClip, citing a lack of "valid scientific evidence" of safety and effectiveness. In briefing documents posted on the regulator's website on Monday, the FDA reviewers said the device's approval would not be appropriate at the time as major questions of safety, efficacy and overall benefit-risk profile for the device remained unanswered. MitraClip Clip Delivery System (CDS) is a percutaneously implanted mechanical clip for the reduction of mitral valve insufficiency - a heart disorder in which the mitral valve does not close properly when the heart pumps out blood, allowing blood to flow backward into the heart. Abbott is seeking approval of MitraClip to reduce mitral valve insufficiency in patients who have been determined by a cardiac surgeon to be too high risk for open mitral valve surgery. The proposed use for the device was changed by Abbott after the FDA had expressed concerns that there was a lack of evidence to support the device's approval for use in patients with significant mitral valve insufficiency, the reviewers said in the documents. Full Article
Abbott Laboratories' Minimally Invasive MitraClip System for Mitral Regurgitation Demonstrates Positive Clinical and Quality-of-Life Results for Patients Too High Risk for Surgery
Abbott Laboratories announced data from the EVEREST II (Endovascular Valve Edge-to-Edge REpair STudy) High Surgical Risk cohort evaluating the Company's first-in-class catheter-based MitraClip() System for the treatment of mitral regurgitation (MR). Findings were presented at the 62nd Annual Scientific Session of the American College of Cardiology in San Francisco. Abbott's MitraClip system, an investigational device in the United States, received CE Mark in 2008 and is commercially available in approximately 30 countries, with more than 8,000 patients treated to date. The device is delivered to the heart through the femoral vein, a blood vessel in the leg, and is designed to reduce MR by clipping together the leaflets of the mitral valve to allow the heart to more efficiently pump blood. The EVEREST II High Surgical Risk cohort included data from patients enrolled in the multi-center EVEREST II High Risk and REALISM continued access studies. Findings from 351 symptomatic U.S. patients deemed too high risk for open mitral valve surgery demonstrated: A 30-day mortality rate significantly lower than expected for surgery (4.8% for patients treated with the MitraClip system versus 18.2% predicted surgical mortality, p<0.0001); A low rate of adverse events, despite the high surgical risk profile of the patients. Full Article
Abbott Laboratories Declares Quarterly Dividend
Abbott Laboratories announced that Board Of Directors declared a quarterly common dividend of 14 cents per share. This marks the 357th consecutive quarterly dividend to be paid by Abbott since 1924. The cash dividend is payable May 15, 2013, to shareholders of record at the close of business on April 15, 2013. Full Article
Abbott Laboratories Issues FY 2013 EPS Guidance
Abbott Laboratories announced that it is issuing ongoing earnings-per-share guidance for fiscal 2013 of $1.98 to $2.04. The Company forecasts net specified items for fiscal 2013 of approximately $0.59 per share, primarily associated with intangible amortization expense, separation costs and cost-reduction initiatives. Including these net specified items, projected earnings per share under Generally Accepted Accounting Principles (GAAP) would be $1.39 to $1.45 for fiscal 2013. 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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