Articles

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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FDA approves Cialis for enlarged prostate

Cialis, Lilly’s blockbuster erectile dysfunction drug, now can be taken to treat enlarged prostate. FDA approval means men who suffer from both disorders can take one medication.

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Health regulatory leaders ready to flock to city

The top event for regulatory professionals in the health care industry is headed to Indianapolis next month. The annual conference of the Regulatory Affairs Professionals Society, or RAPS, is expected to draw thousands of members representing 120 companies and organizations.

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FDA gets new report on Lilly diabetes drug

Drugmakers Eli Lilly and Co. and Amylin Pharmaceuticals Inc. said Monday that patients taking their potential once-weekly diabetes treatment, Bydureon, saw a significant improvement in cardiovascular risk factors.

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FDA says potential diabetes drug may cause cancer

Dapagliflozin would be the first in a new class of diabetes treatments called SGLT2-inhibitors that work by letting patients excrete excess blood sugar in their urine. Indianapolis-based Eli Lilly and Co. is among several companies pursuing similar drugs.

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Two wins to bring Lilly modest sales

Finally, some new revenue. Eli Lilly and Co. will enjoy modest new sales later this year after U.S. regulators approved a new diabetes drug developed by a partner company, and another company nears approval on a drug that will produce royalties for the Indianapolis-based drugmaker.

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