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FDA asks for risk plan info on diabetes drug

SAN DIEGO - Amylin Pharmaceuticals Inc. said Monday it received a Food and Drug Administration request for information on manufacturing and a risk mitigation plan for a potential once-weekly diabetes treatment.The FDA request focuses on product labeling for Bydureon, which is the proposed trade name for exenatide, along with risk mitigation and manufacturing information.The FDA response does not contain requests related to a December preapproval inspection of a manufacturing facility in Ohio.

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FDA warns some patients cannot process Plavix

WASHINGTON - The Food and Drug Administration is adding its strongest warning to the label for Plavix after reports that some patients cannot process the blood thinning drug.The FDA says certain patients with a genetic variation cannot metabolize the drug, putting them at increased risk for heart attack and stroke.Patients can determine if they don't respond to Plavix by taking a genetic test.

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Merck: Study of Vytorin effectiveness to continue

TRENTON, N.J. - Researchers will continue a study of a controversial Merck & Co. cholesterol drug after safety monitors decided data so far indicate the drug is safe and effective, the company said Thursday.The drugmaker said the data safety monitoring board overseeing the study, called IMPROVE-IT, did a preplanned analysis of results halfway through the study."The trial will wrap up in approximately June of 2013," said Merck spokesman Lee Davies.

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Caraco gets FDA approval for generic Eloxatin

DETROIT - Caraco Pharmaceutical Laboratories Ltd. said Thursday it launched a generic version of Sanofi-Aventis' cancer treatment Eloxatin.Teva Pharmaceutical Industries Ltd. also sells a generic version of the drug, which is aimed at colon and rectal cancer.Caraco said it is launching the 50 milligram and 100 milligram generic doses of the drug after the FDA approved Sun Pharma's application.

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Watson says FDA approves 6-month dose Trelstar

MORRISTOWN, N.J. - Watson Pharmaceuticals Inc. said the Food and Drug Administration approved a six-month dose of the prostate cancer drug Trelstar, which already was available in one- and three-month doses.Trelstar is developed by Debiopharm Group of Switzerland and marketed by Watson.Watson plans to launch the six-month dose in May.

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Pfizer says Sutent fails in breast cancer studies

NEW YORK - Pfizer Inc. said Thursday the cancer drug Sutent did not meet key goals in two late-stage studies focusing on advanced breast cancer.Both breast cancer studies combined Sutent with chemotherapy and compared the effectiveness with patients only taking chemotherapy."Sunitinib (Sutent) has been thoroughly evaluated in advanced HER-2 negative breast cancer, and while we are disappointed in the results, these trials have helped us define the limits and opportunities for the compound and better understand the complex biology of this disease," said Dr. Mace Rothenberg, senior vice president of clinical development and medical affairs at Pfizer's oncology business unit.

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Drug used for high potassium questioned

U.S. medical scientists say a drug used to treat high potassium levels for more than 50 years has no proven benefit and probably would not be approved today.The study was led by Dr. Richard Sterns of the University of Rochester School of Medicine and Dentistry."These agents came into widespread use in 1958 -- four years before drug manufacturers were required to prove the effectiveness of their products before gaining FDA approval," Sterns said.

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New CEO, chairman appointed at Bausch & Lomb

ROCHESTER, N.Y. - Two former Schering-Plough executives are taking charge at Bausch & Lomb, whose chairman and CEO is retiring after guiding the company through the aftermath of a devastating contact lens recall.The Rochester, N.Y.-based eye care products maker says that Brent Saunders has been appointed chief executive and Fred Hassan was named chairman.Saunders was president of Schering-Plough's consumer health care unit and Hassan was the drugmaker's CEO and chairman until it was bought in November by Merck for $41.1 billion.

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Watson Receives FDA Approval for Generic Cardizem(R) LA

MORRISTOWN, N.J., March 15 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today announced that its subsidiary, Watson Laboratories, Inc. - Florida, has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Diltiazem Hydrochloride Extended-Release tablets, the generic equivalent to Biovail Laboratories International SRL's Cardizem(R) LA product. Watson intends to launch its generic version of Cardizem(R) LA immediately.About Watson Pharmaceuticals, Inc.

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China Linen Textile Industry Issues Update on Guidance for Full Fiscal Year 2010

LANXI COUNTY, China, March 11 /PRNewswire-Asia-FirstCall/ -- China Linen Textile Industry, Ltd. (OTC Bulletin Board: CTXIF), a China-based company engaged in the production and sale of linen yarn and various types of linen fabric, today revised certain guidance for the full fiscal year ending December 31, 2010. The presentation included 2010 guidance for the Company's estimated revenue, gross profit, net income and fully diluted earnings per share in the amounts of $38.1 million, $12.7 million, $9.3 million and $0.46, respectively. James Shaofeng Qi, Chief Financial Officer of China Linen, stated: "We are pleased with our results for 2009, which we attribute to scientific and technological innovation and the achievement of certain of our development goals.

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