FDA

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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Lilly wins approval for long-acting Zyprexa

December 14, 2009
J.K. Wall
Once-a-month injection of best-selling drug will have patents that could extend until 2018.
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Lilly's Cymbalta wins new approval for anxiety disorder

November 30, 2009
J.K. Wall
FDA action should boost sales of the Eli Lilly and Co. drug, which were already on pace to top $3 billion this year.
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Lilly, GE announce cancer diagnostic breakthrough

October 21, 2009
J.K. Wall
Eli Lilly and Co. and General Electric Co. say they've made a breakthrough in cancer research that could help Lilly cut the size and cost of its clinical trials.
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POWER BREAKFAST: Panel applauds progress, identifies challenges

August 10, 2009
 IBJ Staff
A panel of five leaders of the state’s life sciences industry took on a wide range of topics July 24 at IBJ’s Power Breakfast at the Westin Indianapolis.
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BREAKING: FDA approves Lilly blood-thinner prasugrel

July 10, 2009
J.K. Wall
Eli Lilly and Co. finally won approval today from U.S. regulators to sell prasugrel, its highly anticipated blood thinner, according to Bloomberg News.
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Lilly cancer drug OK'd for new use

July 6, 2009
J.K. Wall
Eli Lilly and Co.'s top rising-star drug has been approved by U.S. regulators for a new use, an event that could boost sales of the medication. Alimta, a lung cancer drug, was approved as a maintenance therapy for non-small cell lung cancer for certain patients, Lilly announced today.
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Commercializing science takes too long, Cook saysRestricted Content

May 25, 2009
Taking science from the laboratory to the commercial market takes too much time and is littered with potential pitfalls along the way.
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Biotech push may help offset generic competition; some analysts skepticalRestricted Content

February 2, 2009
J.K. Wall
Lilly executives want to make biotech their top focus.
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Generic meds cost more than consumers realizeRestricted Content

December 15, 2008
Generic drug makers drive up the cost of name-brand drugs developed by locally based Eli Lilly and Co. and other pharmaceutical firms.
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Lilly expects FDA approval of long-acting version of ZyprexaRestricted Content

February 4, 2008
J.K. Wall
Eli Lilly and Co. hopes to extend the life of its best-seller Zyprexa with a potentially lucrative, long-acting form of the antipsychotic drug. But first, the Indianapolis-based drugmaker must win over a panel of medical experts convened by the U.S. Food and Drug Administration on Feb. 6.
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