FDA

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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Lilly gains panel's backing to expand Cymbalta use

August 19, 2010
Bloomberg News
Outside advisers to the Food and Drug Administration voted 8-6 Thursday in favor of a broader use of Cymbalta on the basis of studies in lower back pain and osteoarthritis of the knee.
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Lilly's Cymbalta helps chronic pain in U.S. review

August 17, 2010
Bloomberg News
Approval for the millions of Americans with chronic back or knee pain may add more than $500 million, or 16 percent, to Cymbalta's annual sales.
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Lilly grows Alimta's sales by shrinking marketRestricted Content

May 29, 2010
J.K. Wall
In 2008, Eli Lilly and Co. asked drug regulators to change the label on Alimta so Lilly could no longer promote it as a treatment for all patients suffering from non-small-cell lung cancer, but for only about 70 percent of the patients. Since then, sales of the drug have accelerated, growing a whopping 48 percent last year.
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Judge rejects controversial Guidant plea agreement

May 8, 2010
Greg Andrews
The deal included a $296 million criminal fine, but no charges against executives who failed to properly report problems with the company's defibrillators.
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Lilly sues to block copy of Evista osteoporosis drug

May 5, 2010
Bloomberg News
Watson Pharmaceuticals filed for FDA approval to sell a low-cost version of Eli Lilly and Co.'s osteoporosis medicine. Indianapolis-based Lilly is seeking a court order that would block approval until three of its patents expire in 2017.
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Lilly diabetes drug may have cancer risk, FDA says

April 9, 2010
 IBJ Staff and Bloomberg News
Once-weekly form of Byetta is awaiting the FDA's OK. Analyst predict the new version of the drug, if approved, could rack up sales of $2 billion annually.
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Louisiana gets $20M in Lilly drug settlement

April 7, 2010
Associated Press
Louisiana was one of 13 states that filed individual suits in state courts over allegations that Lilly pushed Zyprexa for uses that had not been approved by federal regulators.
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Indiana food manufacturers ramp up safety precautions

March 20, 2010
Kathleen McLaughlin
The peanut-borne salmonella outbreak of 2009 raised awareness about the risk of illness from unlikely sources. Unfortunately, that wasn’t the last time a seemingly innocuous ingredient made people sick, and prompted recalls.
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Lilly sues to block generic of Adcirca lung treatment

March 17, 2010
Bloomberg News
Netherlands-based Synthon Pharmaceuticals is seeking U.S. Food and Drug Administration approval to sell a copy of the medicine.
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FDA says 'not yet' on Lilly's once-weekly Byetta

March 15, 2010
J.K. Wall
Regulators won't require more time-consuming tests of the drug, but want Eli Lilly and Co. and its partners to clarify labeling, manufacturing processes.
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Pfizer's Viagra patent partially rejected in Lilly fight

February 16, 2010
Bloomberg News
The patent on impotence drug Viagra was partially rejected after the U.S. Patent and Trademark Office said it wasn't different enough from a Chinese herb known as Horny Goat Weed. The patent was key to an infringement suit Pfizer filed in 2002 against Eli Lilly and Co. over its rival Cialis drug.
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Lilly shares get boost from OK of rival's drug

January 26, 2010
 IBJ Staff and Bloomberg News
Shares of Lilly and partner Amylin rose on hopes that their new version of Byetta will be approved following U.S. regulators' clearance of a similar drug.
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Biotech firm plans $28M Greenwood plant

January 19, 2010
Greenwood pharmaceutical firm Elona Biotechnologies plans to build a $28 million production facility and create 70 jobs to help develop a cheaper form of insulin that could gain significant market share.
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FDA letters scold Lilly, others over marketing materials

January 13, 2010
Associated Press
The letter to Indianapolis-based Lilly cites a print advertisement for the antidepressant Cymbalta that did not adequately display information about the drug's side effects.
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FDA cancels meeting to review Lilly's Cymbalta

January 5, 2010
Associated Press
The agency said the meeting was canceled "to allow time for the FDA to review new information" about a proposed new use for the drug.
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