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Industry News

August 29 – September 4, 2005

Sept 2nd: Medtronic Acquires Image-Guided Neurologics

Medtronic announced that it has acquired Image-Guided Neurologics (IGN) of Melbourne, Fla., a privately held company that specializes in precision navigation and delivery technologies for brain surgery.
Specific terms of the agreement were not disclosed.
Medtronic said the IGN product line, which includes the NexFrame disposable, "frameless" stereotactic head frame, strengthens its leadership position in deep brain stimulation (DBS) by offering instruments that simplify the procedure for surgeons and improve patient comfort during surgery.

Sept 2nd: Quinton Cardiology Systems and Cardiac Science Announce Completion of Merger

Quinton Cardiology Systems, Inc., a global leader in advanced cardiology products, and Cardiac Science, Inc., a leading provider of life-saving automated external defibrillators (AEDs), today announced they completed their merger, resulting in a combined company called Cardiac Science Corporation.
The merger was approved in special meetings yesterday by the respective stockholders of both Cardiac Science and Quinton. Approximately 96 percent of the shares of Cardiac Science common stock cast at the Cardiac Science special meeting voted in favor of the merger proposal and approximately 97 percent of the shares of Quinton common stock cast at the Quinton special meeting voted in favor of the merger proposal. The merger agreement was originally approved by the boards of directors of both companies in February 2005.

Sept 2nd: Study Holds Promise For New Way To Fight HIV

Researchers have confirmed for the first time the benefit of an innate defense system present in the few patients who remain healthy after years of infection with HIV despite receiving no treatment, according to an article published in the September edition of the Journal of Virology. The study found that the subset of HIV-infected patients referred to as long-term survivors or nonprogressors have higher amounts of a key enzyme in their white blood cells. At the same time, a related biotech company is poised to begin preclinical testing on a drug designed to confer similar protection on most HIV patients. Approximately five percent of patients with HIV, or human immunodeficiency virus, do not develop AIDS, or do so very slowly. Researchers have been trying for years to understand what sets long-term nonprogressors apart. Past research suggested that such patients maintain higher levels of an enzyme in white blood cells called APOBEC-3G (A3G), and the new study confirmed it in the first experiments on human cells.

Sept 1st: Novartis AG Offers $4.5B Cash To Complete Takeover Of Chiron Corporation

Novartis announced today that it has made a proposal to the independent directors of Chiron Corporation to acquire all of the remaining outstanding shares that it does not already own and has filed an amended Form 13-D as required by the U.S. Securities and Exchange Commission. Novartis currently holds a 42.2% stake in the U.S. biopharmaceutical company and has submitted a proposal to acquire the approximately 112 million fully diluted shares (treasury method) of Chiron for USD 40.00 per share in cash, or a total of USD 4.5 billion.

Sept 1st: FDA official quits over Plan B pill delay

The director of the Food and Drug Administration's Office of Women's Health resigned Wednesday because the agency has not yet decided whether emergency contraception can be sold over the counter.
The delay in making "morning-after pills" available without a prescription "is contrary to my core commitment to improving and advancing women's health," Susan Wood, director of the women's health office for nearly five years, said in an e-mail to colleagues and women's health activists.
FDA Commissioner Lester Crawford said Friday that he delayed a decision because it's not clear whether Barr Pharmaceuticals' plan to sell Plan B emergency contraception over the counter to women 16 and older but by prescription to younger teens is legal or enforceable.

Aug 31st: FDA announces nationwide recall of Medline brand of alcohol-free mouthwash and hygiene kits containing mouthwash because of possible health risk

The U.S. Food and Drug Administration (FDA) is notifying the public of a nationwide voluntary recall of alcohol-free mouthwash and hygiene kits containing mouthwash distributed by Medline Industries, Inc., Mundelein, Ill. because of the potential contamination with Burkholderia cepacia. Consumers and health care providers who have Medline brand alcohol free mouthwash should stop using the product immediately and check to see if it is being recalled.

Aug 31st: Beckman Coulter signs rapid diagnostics supply agreement with Princeton BioMeditech Corp.

In a move that underscores its growing commitment to the market for rapid diagnostic medical test products, Beckman Coulter Inc has entered into a supply relationship with Princeton BioMeditech Corp (PBM). Under the agreement, PBM will supply a wide range of rapid diagnostic tools used at the point of medical care to Beckman Coulter's Primary Care Diagnostics business unit. Princeton BioMeditech Corp is a leading innovator and manufacturer of simple and rapid diagnostic products used at the point of care. Based in Princeton, NJ, the company offers more than 70 tests covering fertility management, infectious diseases, cardiac markers, drugs of abuse, cancer markers, environmental and veterinary diagnostics. Based in Fullerton, CA, Beckman Coulter Inc is a leading manufacturer of biomedical testing instrument systems, tests and supplies that simplify and automate laboratory processes.

Aug 30th: Genencor Receives Defense Contract to Develop a Process for Emergency Pharmaceutical Manufacturing

Genencor International, a Danisco company, announced today that it has received a grant from the U.S. Defense Advanced Research Projects Agency (DARPA) to develop a process for rapid manufacture of emergency pharmaceuticals to defend against biological agents.
The process will be based upon Genencor's technology for large scale manufacture of monoclonal antibodies in fungal systems which can, theoretically, be used to mass produce a number of newly identified vaccine or therapeutic candidates. The goal is to be able to manufacture 10 million doses of vaccine within 2 months of identifying the biological agent.

Aug 30th: Celera Diagnostics Identifies New Heart Attack Genes

Variations in human genes may raise a person's risk of a heart attack as much as smoking or high blood pressure, according to new findings from Celera Diagnostics. The research company says it has linked variations in four genes with an increased risk for heart attack. None of the genes had been previously associated with a heart attack, and the discovery could lead to new treatments for coronary heart disease. Celera says the gene variants identified can cause the same kind of increased risk for a heart attack as high cholesterol, hypertension or smoking. Celera Diagnostics, a joint venture between Applied Biosystems and Applera-Celera Genomics Group (NYSE: CRA) in Rockville, will publish the findings in the American Journal of Human Genetics.

Aug 29th: Third Wave Technologies receives FDA clearance of pharmacogenetic test

Third Wave Technologies Inc announced that the US Food and Drug Administration (FDA) has cleared the company's Invader UGT1A1 Molecular Assay for in vitro diagnostic use. It is the first pharmacogenetic test to be approved by the FDA for use as a companion diagnostic to a specific drug therapy. The Invader UGT1A1 test is cleared for use to identify patients who may be at increased risk of adverse reaction to the chemotherapy drug Camptosar (irinotecan) by detecting and identifying specific mutations in the UGT1A1 gene that have been associated with that risk. Camptosar is used to treat colorectal cancer and was relabelled recently to include dosing recommendations based on a patient's genetic profile. Third Wave Technologies is a leader in the development and marketing of molecular diagnostics for a variety of DNA and RNA analysis applications, providing physicians and researchers with superior tools to diagnose and treat disease.

Aug 29th: First Production Of Human Monoclonal Antibodies In Chicken Eggs Published In Nature Biotechnology

Origen Therapeutics today announced the first published scientific report of fully functional, human sequence monoclonal antibodies (mAbs) produced in chickens. The antibodies were expressed solely in the chicken oviduct and deposited into egg white in concentrations of 1-3 milligrams per egg. Moreover, antibodies produced in this manner demonstrated 10-100 fold greater cell-killing ability (ADCC) compared to therapeutic antibodies produced by conventional cell culture methods. The new report was published in the September issue of Nature Biotechnology by researchers from Origen Therapeutics and their collaborators at Medarex, Texas A&M University and the University of California, Los Angeles. A research brief commenting on the potential impact of this development for the production of human therapeutic proteins was also published in the September issue of Nature Medicine.

 

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