FDA

At long last, Roche wins approval of Nano

January 16, 2012
J.K. Wall
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

November 15, 2011
Bloomberg News
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

November 14, 2011
Bloomberg News
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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Lilly, Bristol-Myers approved to market wider Erbitux use

November 7, 2011
Bloomberg News
Eli Lilly and Co. and Bristol-Myers Squibb Co. won U.S. approval to expand marketing of the cancer drug Erbitux for late-stage head and neck tumors.
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FDA approves first generic versions of Zyprexa

October 24, 2011
 IBJ Staff and Associated Press
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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Lilly diabetes drug wins approval for expanded use

October 19, 2011
Bloomberg News
Eli Lilly and Co. and Amylin Pharmaceuticals Inc.’s Byetta has received expanded approval for use with the world’s top-selling insulin to treat Type 2 diabetes.
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Q&A

October 17, 2011
J.K. Wall
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: Cook Medical’s stent met efficacy, safety goals

October 11, 2011
Bloomberg News
Peripheral vascular devices, including stents, angioplasty balloons and synthetic grafts, generated $4.3 billion in global revenue last year and may earn $5.6 billion in 2014.
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FDA approves Cialis for enlarged prostate

October 7, 2011
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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Debate rages over whether Lilly's Byetta lifts cancer risk

September 16, 2011
Bloomberg News
A German researcher disputed the validity of a study that found Byetta and another diabetes drug increase cancer risk.
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Health regulatory leaders ready to flock to city

September 14, 2011
 IBJ Staff
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

September 12, 2011
Associated Press
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 deal with drugmakers raises user fees 6 percent

September 1, 2011
Bloomberg News
Drugmakers including Eli Lilly an Co. have agreed with regulators on a 6-percent increase in review fees as part of reauthorizing the drug-approval process through fiscal 2017.
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FDA says potential diabetes drug may cause cancer

July 18, 2011
Bloomberg News
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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Lilly, partner find no Bydureon effect on heart rhythm

June 27, 2011
Bloomberg News
Eli Lilly and Co., Amylin Pharmaceuticals Inc. and Alkermes Inc. said an analysis of a 148-patient trial found no evidence that their experimental Bydureon diabetes drug causes prolonged heart rhythms.
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Lilly drug to detect Alzheimer’s criticized by consumer group

May 11, 2011
Bloomberg News
Eli Lilly and Co.’s Amyvid, an experimental imaging agent to detect signs of Alzheimer’s disease in the brain, shouldn’t be approved because of unreliable study results, a consumer-advocacy group said.
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Two wins to bring Lilly modest sales

May 9, 2011
J.K. Wall
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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FDA OKs new diabetes pill from Lilly, Boehringer

May 2, 2011
 IBJ Staff and Associated Press
The Food and Drug Administration says it has approved a new diabetes pill from Boehringer Ingelheim and Eli Lilly for patients who can't control their blood sugar with older medicines.
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FDA wants further testing of Lilly pancreas drug

April 16, 2011
Associated Press
Eli Lilly and Co. Inc. said Friday that the FDA has asked the drugmaker to conduct another clinical trial of its proposed pancreas drug before it resubmits an application to have the drug approved for sale.
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Regulators delay approval of Lilly's Alzheimer’s screen

March 18, 2011
Bloomberg News
The Food and Drug Administration said Lilly needs to create a training program to ensure brain scans are interpreted properly.
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Lilly confident of FDA approval for Amyvid, Lechleiter says

March 9, 2011
Bloomberg News
Eli Lilly and Co. CEO John Lechleiter said he’s confident of gaining U.S. regulatory approval for a drug to help identify plaque in the brain associated with Alzheimer’s disease.
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Endocyte again changes terms of public offering

February 4, 2011
 IBJ Staff and Bloomberg News
The West Lafayette-based biopharmaceutical company now is planning to offer at least 12.5 million shares, or 17 percent more than previously announced, but at a lower price of $6 each.
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Lilly, Bristol-Myers halt enrollment in lung-cancer trial

February 2, 2011
J.K. Wall
Eli Lilly and Co. and Bristol-Myers Squibb Co. stopped enrolling new patients in a clinical trial of an experimental lung cancer drug over concerns about patients developing blood clots.
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Lilly product gets boost; Wall Street yawns

January 26, 2011
J.K. Wall
Eli Lilly and Co. probably will get approval for its newly acquired imaging agent used to diagnose Alzheimer’s disease, but so far analysts are unimpressed.
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Lilly imaging drug fails to win FDA panel's backing

January 21, 2011
Bloomberg News
Eli Lilly and Co.'s Amyvid isn't ready to be approved to detect Alzheimer's-related deposits in the brain, according to FDA advisors. The medicine could still be approved if Lilly establishes a training program and a way to ensure that the results of brain scans are read consistently, they said.
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