Articles

J&J wins OK for first in new class of diabetes drugs

Johnson & Johnson, the world’s largest seller of health-care products, won approval for the first in a new family of diabetes drugs, giving them the edge against rivals including Eli Lilly and Co. that are developing similar medicines.

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Lilly aims to submit five new drugs for approval

With Eli Lilly and Co. set to see patents expire on its best-selling drug at year’s end, it is in the company’s interest to say its pipeline is about to produce new drugs. But the Indianapolis drugmaker may be in a position to submit five new drugs for regulatory approval this year.

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Lilly competitor gets backing on diabetes drug

Johnson & Johnson, the world’s largest seller of health-care products, won the backing of U.S. advisers for a diabetes pill the company is seeking to make the first in a new family of drugs for managing blood sugar.

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FDA proposes sweeping new food safety rules

The Food and Drug Administration on Friday proposed the most sweeping food safety rules in decades, requiring farmers and food companies to be more vigilant in the wake of deadly outbreaks in peanuts, cantaloupe and leafy greens.

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Cook wins approval for new stent

Bloomington-based Cook Medical won approval for the first drug-coated stent for clogged leg arteries in the United States, which accounts for 40 percent of the soon-to-be $3 billion market.

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Lilly’s Alzheimer’s drug trials show mixed results

Eli Lilly and Co.’s experimental Alzheimer’s drug failed to meet its primary goals in two separate clinical trials. However, when the results of both trials were combined, the drug appeared to have slowed the decline of cognition in some patients.

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FDA’s $6.4B drug review fee plan passes Senate

The U.S. Senate voted to let regulators collect on a $6.4 billion fee agreement struck with Indianapolis-based Eli Lilly and Co., Medtronic Inc. and other companies to fund reviews of new drugs and medical devices through 2017.

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At long last, Roche wins approval of Nano

The OK for a new blood glucose monitor comes more than two years after FDA officials declined to approve a previous version of the Nano, which in rare cases generated inflated blood sugar readings because it did not distinguish properly between the sugars glucose and maltose.

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Potential Lilly drug doubles good cholesterol

Eli Lilly and Co.’s experimental drug doubled levels of good cholesterol in a study, setting up a race with Merck & Co. and Roche Holding AG to develop a new class of medicines to lower heart risk.

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Potential Effient rival shows promise in study

A study showing Johnson & Johnson and Bayer AG’s blood-thinner Xarelto succeeded where rival drugs failed could give the companies entry to a $1 billion-plus market where Eli Lilly already competes.

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FDA approves first generic versions of Zyprexa

Federal health officials on Monday approved the first generic versions of the blockbuster drug Zyprexa, which posted sales of $5.7 billion last year for Indianapolis-based drugmaker Eli Lilly and Co Inc.

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Q&A

Sherry Keramidas, who earned her doctorate in neuroscience and physiological psychology from Purdue University, is executive director of the Maryland-based Regulatory Affairs Professionals Society, which is holding its annual conference Oct. 22-26 at the Indiana Convention Center.

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