FDA

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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Carmel firm gets FDA approval for lice treatment

January 18, 2011
 IBJ Staff
ParaPRO LLC's treatment, called Natroba, has a potential U.S. market of 6 million to 12 million infected children annually.
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Lilly imaging drug isn't ready for approval, FDA says

January 18, 2011
Eli Lilly and Co.’s experimental drug to help identify plaque in the brain tied to Alzheimer's disease isn't ready for approval, according to U.S. regulators.
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Panel says Lilly’s Solpura isn’t ready for approval

January 12, 2011
Bloomberg News
Eli Lilly and Co. failed to win an FDA advisory panel’s recommendation to introduce the first pancreatic enzyme that isn’t derived from pig parts.
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Lilly partner moves up timetable for diabetes drug

January 11, 2011
Bloomberg News
Amylin Pharmaceuticals Inc., rebuffed twice in its bid for U.S. approval of a weekly diabetes drug, will meet its timetable and submit a heart-safety study to regulators by the end of 2011, its CEO said.
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Lilly's Solpura may lack data to prove effectiveness

January 10, 2011
Bloomberg News
Outside advisers to the FDA will meet Jan. 12 to review whether the drug should be approved for people with pancreas insufficiency caused by cystic fibrosis, chronic pancreatitis or other conditions.
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Lilly, other big drugmakers shut out by FDA in 2010

January 3, 2011
 IBJ Staff and Bloomberg News
Regulators cleared 21 medicines, the fewest since 2007, for sale last year. It was the first time in a decade that Pfizer Inc., the world's largest drugmaker, as well as Lilly, Merck & Co. and Bristol-Myers Squibb Co. were shut out at the same time, according to agency records.
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Lilly, Acrux receive FDA approval for Axiron

November 24, 2010
 IBJ Staff and Bloomberg News
The companies believe the underarm testosterone solution has the potential to realize sales of more than $1 billion a year in the United States.
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Lilly wins approval of antidepressant Cymbalta for pain

November 4, 2010
Bloomberg News
The Food and Drug Administration has cleared Cymbalta for musculoskeletal pain such as arthritis and chronic lower back conditions, which could mean another $500 million in annual sales for Lilly, an analyst estimates.
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Analysts: Lilly setbacks might spur shopping spree

October 22, 2010
Bloomberg News
CEO John Lechleiter claims Eli Lilly and Co. isn't interested in big acquisitions to bolster its flagging drug pipeline, but its recently devalued partner Amylin Pharmaceuticals might be the right fit, industry analysts say.
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UPDATE: Lilly, others see stock slide after drug rejection

October 20, 2010
Bloomberg News
Stock in Eli Lilly and Co., Amylin Pharmaceuticals Inc. and Alkermes Inc. dropped after they were rebuffed a second time in a bid to gain U.S. approval of a once-weekly version of the diabetes drug Byetta.
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FDA demands more tests on new Lilly diabetes drug

October 19, 2010
J.K. Wall
Eli Lilly and Co. will have to wait at least 18 months and conduct more studies before it wins market approval of a once-weekly version of diabetes drug Byetta, a potential billion-dollar drug.
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Lilly falls short on 'field goal' attempt

October 13, 2010
J.K. Wall
Eli Lilly and Co.’s “miss” on a new use for its cancer drug Alimta was a rare failure to get an existing drug approved for a new use—even though the company has struggled mightily to get entirely new drugs to market.
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Endocyte's $86M IPO plan a boon for Indiana, investors

August 28, 2010
Greg Andrews
Venture capitalists in Indiana and nationally have thrown money at the company with abandon. Local investors include CID Capital, Clarian Health Ventures and the Indiana Future Fund.
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