Abbott Laboratories announced that, it has received CE Mark for its XIENCE PRIME Everolimus Eluting Coronary Stent System for the treatment of critical limb ischemia (CLI) or severe claudication (pain) of the lower leg. CLI is the most advanced form of peripheral artery disease (PAD) that can ultimately lead to limb amputation. With this expanded indication, XIENCE PRIME can be marketed to treat CLI or severe claudication of the lower leg in European Union countries and others that recognize CE Mark.
Abbott announced today that it has entered into an agreement with GlaxoSmithKline
(GSK) to develop a molecular diagnostic test intended for use as an aid in
selecting patients who may benefit from a skin cancer treatment in development
"This is an exciting continuation of our important collaboration with GSK, a leading company in cancer immunotherapy research," said Stafford O'Kelly, head of Abbott's molecular diagnostics business. "The agreement is indicative of our commitment to personalized medicine and our focus on developing innovative companion diagnostic tests that can be used to identify patients most likely to benefit from specific cancer therapies."
A new diagnostic tool physicians can use to monitor patients for the most common form of ovarian cancer may soon be available in the United States. Abbott’s ARCHITECT HE4 assay uses a simple blood test to help in monitoring for the recurrence or progression of epithelial ovarian cancer. If approved, this important immunoassay would be the first automated HE4 test available in the United States.
"The ability to monitor the recurrence or progression of ovarian cancer is a critical part of patient care. The ARCHITECT HE4 assay has the potential to be a powerful tool for both physicians and patients in the management of the disease," said Michael Warmuth, senior vice president, diagnostics, Abbott.
Abbott’s Ibis technology for detecting and characterizing a vast array of microorganisms has been named one of the top innovations in 2009 by The Scientist magazine.
Abbott’s Ibis system (now marketed under the PLEX ID trade name) was recognized for the honor, in part, because it is designed to detect and characterize a broad range of microorganisms in a given sample, including viruses, bacteria and fungi.
Abbott Laboratories announced a definitive agreement to acquire the global rights to PanGenetics BV's PG110 fully humanized antibody to Nerve Growth Factor (NGF).
PG110 is a biologic in Phase I clinical trial development that targets NGF for the treatment of chronic pain. NGF is released at sites of tissue damage and inflammation, and plays a significant role in the transmission of pain signals by the central nervous system.
The law firm Arnold & Itkin LLP has filed five lawsuits against the makers of pain pumps and related medications, including Abbott Labs, based on claims that many of the companies' defective devices are causing irreversible shoulder damage among patients. Currently, the attorneys at Arnold & Itkin are representing 28 people who received pain pumps to manage pain following shoulder surgery.
According to the lawsuits, pain pump manufacturers were denied approval by the U.S. Food and Drug Administration to use the pumps to mitigate pain in shoulder joints, but the companies continued to promote their use in that way. Many former pain pump users say the companies were negligent in designing, researching and selling pain pumps that they should have known were dangerous.
The U.S. Justice Department is investigating Abbott Laboratories' sales and marketing activities for its anti-seizure drug Depakote, the drug maker disclosed.
Abbott said in a regulatory filing that the U.S. Attorney for the Western District of Virginia is seeking to determine whether Abbott's marketing activities violated civil or criminal laws including the Federal False Claims Act, the Food and Drug Cosmetic Act, and the Anti-Kickback Statute "in connection with Medicare and/or Medicaid reimbursement to third parties."
Abbott announced that it has completed its acquisition of Evalve, Inc., the
global leader in the development of devices for minimally invasive repair of
The acquisition provides Abbott with a leading presence in the growing area of non-surgical treatment for structural heart disease. Evalve's minimally invasive catheter-based MitraClip® system is the first commercially available treatment option approved in Europe for non-surgical mitral valve repair for patients suffering from the effects of mitral regurgitation, a condition that prevents the heart's mitral valve from closing completely.
A European regulatory body plans to examine whether certain cholesterol drugs have long-term clinical benefits and one potential outcome could be their withdrawal from the market if they come up short.
The review will have implications for Abbott Laboratories and the pharmaceutical unit of Solvay SA, which Abbott is in the process of acquiring for $6.6 billion. Abbott and Solvay co-market the drugs TriCor and Trilipix, which are in a category the European regulatory body will assess.
Abbott today dedicated its new Abbott Nutrition facility at the Research Park on the University of Illinois campus.
Abbott will use the facility to research and develop nutritional products for infants through adults. The company, which operates more than 100 facilities worldwide and sells products in more than 130 countries, will initially collaborate with faculty and students in the College of Agricultural, Consumer and Environmental Sciences. The company is beginning with 11 student interns and full time management.
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