Clinical Trials

Timing good for 2-in-1 biotech drugs

July 5, 2011
J.K. Wall
Eli Lilly and Co.’s foray into combination drugs is well-timed because the company could take advantage of some the world’s most successful biotech medicines, which are about to see their patents expire.
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Lilly plans 10 drugs in final-stage trials by year's end

June 30, 2011
Bloomberg News
Lilly has 33 drugs in the second and third stages of clinical trials, including medicines for cancer, diabetes and Alzheimer’s disease, up from seven in 2005, the Indianapolis-based company said Thursday.
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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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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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China making big gains in drug R&D jobs state covets

April 9, 2011
Greg Andrews
The total annual cost for one researcher at Lilly might run $300,000 to $350,000 a year. The figure at Crown Bioscience is one-third of that, said a company executive.
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Eli Lilly neuroscience chief resigns

February 25, 2011
J.K. Wall
David Bredt, vice president of neuroscience research, has resigned “to pursue other opportunities,” according to Lilly spokeswoman Judy Kay Moore. Bredt had overseen Lilly’s development of various drugs, including molecules in late-stage human testing to treat Alzheimer’s and depression.
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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 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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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, 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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Indiana Seed Fund makes 11th investment

December 23, 2010
 IBJ Staff
A $250,000 investment in Aarden Pharmaceuticals will go toward advancing tuberculosis therapy through the pre-clinical development stage.
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Lilly suspends late-stage trial for melanoma drug

December 13, 2010
Bloomberg News
Eli Lilly and Co. suspended a late-stage clinical trial of a medicine for skin-cancer patients after 12 patients in the study died.
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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 scores series of small victories

November 17, 2010
J.K. Wall
The Indianapolis-based drugmaker finally won FDA approval for its antidepressant Cymbalta to treat chronic pain and fended off a patent challenge to rising-star cancer drug Alimta, but got a ratings downgrade on its debt.
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Study: Arthritis drug co-developed by Lilly shows promise

November 12, 2010
 IBJ Staff and Bloomberg News
Lilly paid $90 million in 2009 to acquire the global rights to the treatment in a bid to beef up its pipeline of medications for autoimmune diseases.
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Eli Lilly will have to beat odds to meet drug-rollout goals

October 30, 2010
J.K. Wall
Eli Lilly and Co. executives have said repeatedly that the company’s bulging pipeline will produce two new drugs per year, beginning in 2013. But only three times in the past six decades has Lilly been able to launch two or more new drugs in back-to-back years.
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Lilly suspends clinical trials after diabetes treatment fails

October 20, 2010
Bloomberg News
Eli Lilly and Co. and its development partner said an experimental diabetes treatment failed to help patients in a late-stage study, the second setback for a Lilly diabetes drug candidate in two days.
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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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Q&A

October 20, 2010
J.K. Wall

Amy Zucker is president of Indianapolis-based Synergy Marketing Group. Her firm was recently hired by Indianapolis-based ImmuneWorks Inc. to use a new website and search engine optimization to help recruit patients for a Phase 1 trial of ImmuneWorks experimental medicine idiopathic pulmonary fibrosis. The Web strategy is a new wrinkle on patient recruitment—in addition to the traditional partnerships with disease specialists at academic medical centers—that Zucker hopes leads to lower costs and faster clinical trials. Phase 1 clinical trials cost nearly $16,000 per patient.

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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's Erbitux shows mixed results in cancer studies

October 11, 2010
Bloomberg News
In combination with chemotherapy, the drug failed to help colon-cancer patients in a European trial but did delay the spread of breast cancer in some patients with a certain type of aggressive tumor.
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Pearl IRB first firm in state to pre-screen clinical drug trialsRestricted Content

August 21, 2010
Chris O'Malley
Two former Eli Lilly and Co. employees launched the firm that promises to attract more clinical trial business to the state.
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Lilly halts development of Alzheimer's drug

August 17, 2010
 IBJ Staff and Associated Press
Studies showed that the treatment did not slow the disease's progression. It's just the latest setback for the pharmaceutical giant, which lost a patent lawsuit over a major drug last week and faces an unprecedented number of patent expirations through 2014.
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Diagnostics division to help Lilly tailor treatmentsRestricted Content

July 10, 2010
J.K. Wall
Eli Lilly and Co. is launching a diagnostics division to produce tests that can winnow out the patients most likely to benefit from a Lilly drug.
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Lilly, Amylin stock rises on drug postponement

June 18, 2010
 IBJ Staff and Bloomberg News
Roche Holding AG's decision to postpone its experimental diabetes drug is helping boost shares in Amylin Pharmaceuticals Inc. and drug partner Eli Lilly and Co.
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