FDA

Lilly wins approval for potential blockbuster drug

April 21, 2014
Bloomberg News
The Indianapolis-based pharmaceutical maker gets a much-needed boost with FDA approval for gastric-cancer drug ramucirumab, which quickly could account for $1 billion in annual sales.
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Pfizer, Lilly drugs slow advanced breast cancer in studies

April 7, 2014
Bloomberg News
Pfizer Inc., Eli Lilly and Co. and Novartis AG have dug an idea out of the pharmaceutical dustbin to create new medicines that are showing blockbuster potential.
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Would-be Lilly foe wins U.S. panel backing for inhaled insulin

April 1, 2014
Bloomberg News
Advisers to the Food and Drug Administration voted 13-1 and 14-0 that the drug, Afrezza, should be approved for Type 1 and Type 2 diabetes, respectively. The FDA doesn’t have to follow the panel’s recommendation.
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Lilly diabetes drug rejected by FDA over manufacturing issue

March 5, 2014
Bloomberg News
The Lilly-Boehringer drug empagliflozin is projected to reach sales of $295 million for Lilly in 2019, but it won't be able to sell it until issues are resolved at a German plant.
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Analysts: Endocyte likely to receive green light on first drug this month

March 3, 2014
J.K. Wall
The European Committee for Medicinal Products for Human Use is scheduled to meet March 17-20, and analysts expect the agency to vote during that meeting to approve vintafolide, Endocyte’s first drug, which treats ovarian cancer.
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Lilly diabetes drug matches competitors' effectiveness

February 25, 2014
 IBJ Staff and Bloomberg News
The Indianapolis drugmaker said dulaglutide performed as well as Victoza, a best-selling drug for Type 2 diabetics made by Denmark-based Novo Nordisk. Analysts think dulaglutide could reach annual sales of $1.5 billion.
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Testosterone drugs under FDA review for heart-attack risk

February 3, 2014
Bloomberg News
Testosterone drugs, which make up a growing market for pharmaceutical companies such as Eli Lilly, are getting a closer look from U.S. regulators.
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Lilly pledges up to $1.8B to Pfizer for access to potential blockbuster

November 11, 2013
J.K. Wall
Eli Lilly and Co. and Pfizer Inc., which are both suffering through some of the largest patent cliffs in the industry, will split any future costs and profits of an osteoarthritis drug that has stalled in clinical testing.
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Investors brace for lean years from LillyRestricted Content

October 12, 2013
J.K. Wall

In a new round of predictions this month, Wall Street analysts indicated they expect Eli Lilly and Co.’s revenue to fall next year and to remain below 2013 levels until 2020.

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Lilly's new strategy built around head-to-head drug trialsRestricted Content

August 10, 2013
J.K. Wall
Lilly has set up not one, not two, but five head-to-head trials of its experimental drug dulaglutide against other leading diabetes therapies. So far, dulaglutide’s record is four wins, no losses.
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J&J wins OK for first in new class of diabetes drugs

March 31, 2013
Bloomberg News
Johnson & Johnson, the world’s largest seller of health-care products, won approval for the first in a new family of diabetes drugs, giving them the edge against rivals including Eli Lilly and Co. that are developing similar medicines.
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Lilly, Boehringer submit diabetes drug to FDA

March 25, 2013
Associated Press
Eli Lilly and Co. said Monday that it has submitted a new type 2 diabetes treatment it is developing with German drugmaker Boehringer Ingelheim to the Food and Drug Administration.
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Endocyte stock sinks due to possible drug-filing delay

February 26, 2013
J.K. Wall
Endocyte Inc. saw its shares fall nearly 7 percent Tuesday morning after the drug development firm announced that its application for U.S. approval of a cancer drug could be delayed another 10 months.
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Lilly aims to submit five new drugs for approval

February 4, 2013
J.K. Wall
With Eli Lilly and Co. set to see patents expire on its best-selling drug at year’s end, it is in the company’s interest to say its pipeline is about to produce new drugs. But the Indianapolis drugmaker may be in a position to submit five new drugs for regulatory approval this year.
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Lilly competitor gets backing on diabetes drug

January 10, 2013
Bloomberg News
Johnson & Johnson, the world’s largest seller of health-care products, won the backing of U.S. advisers for a diabetes pill the company is seeking to make the first in a new family of drugs for managing blood sugar.
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Cook wins approval for new stent

November 19, 2012
J.K. Wall
Bloomington-based Cook Medical won approval for the first drug-coated stent for clogged leg arteries in the United States, which accounts for 40 percent of the soon-to-be $3 billion market.
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Lilly's Alzheimer's drug trials show mixed results

August 24, 2012
Bloomberg News, J.K. Wall
Eli Lilly and Co.’s experimental Alzheimer’s drug failed to meet its primary goals in two separate clinical trials. However, when the results of both trials were combined, the drug appeared to have slowed the decline of cognition in some patients.
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FDA’s $6.4B drug review fee plan passes Senate

May 24, 2012
Bloomberg News
The U.S. Senate voted to let regulators collect on a $6.4 billion fee agreement struck with Indianapolis-based Eli Lilly and Co., Medtronic Inc. and other companies to fund reviews of new drugs and medical devices through 2017.
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Eli Lilly's Cialis faces faster-acting competition

April 30, 2012
 IBJ Staff and Bloomberg News
A Vivus Inc. pill that is supposed to provide erections within 15 minutes, about half the time or less than Eli Lilly and Co.'s Cialis or Pfizer Inc.’s Viagra,  has received U.S. regulatory approval.
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Lilly receives Europe's OK for new Byetta use

March 23, 2012
 IBJ Staff and Associated Press, Associated Press
European regulators have approved an expanded use for the diabetes treatment Byetta, developed by Eli Lilly and Co. and Amylin Pharmaceuticals Inc. The FDA approved the same expanded use last fall.
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FDA removes hurdle in Endocyte's path to drug approval

March 5, 2012
J.K. Wall
Endocyte Inc. can start enrolling patients again in a clinical trial of its experimental cancer drug, the company announced Monday, clearing away a hurdle to getting the drug approved in Europe.
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Lilly's ex-partner wins FDA approval for diabetes drug

January 29, 2012
Bloomberg News
Amylin Pharmaceuticals Inc. and Alkermes Plc have gained U.S. clearance for Bydureon, a once-weekly diabetes shot. Eli Lilly and Co. co-developed the drug, but ended its partnership with Amylin last year.
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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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  1. So much for Eric Holder's conversation about race. If white people have got something to say, they get sued over it. Bottom line: white people have un-freer speech than others as a consequence of the misnamed "Civil rights laws."

  2. I agree, having seen three shows, that I was less than wowed. Disappointing!!

  3. Start drilling, start fracking, and start using our own energy. Other states have enriched their citizens and nearly elminated unemployment by using these resources that are on private land. If you are against the 'low prices' of discount stores, the best way to allow shoppers more choice is to empower them with better earnings. NOT through manipulated gov mandated min wage hikes, but better jobs and higher competitive pay. This would be direct result of using our own energy resources, yet Obama knows that Americans who arent dependent of gov welfare are much less likely to vote Dem, so he looks for ways to ensure America's decline and keep its citizens dependent of gov.

  4. Say It Loud, I'm Black and Ashamed: It's too bad that with certain "black" entertainment events, it seems violence and thuggery follows and the collateral damage that it leaves behinds continues to be a strain on the city in terms of people getting hurt, killed or becoming victims of crimes and/or stretching city resources. I remember shopping in the Meadows area years ago until violence and crime ended make most of the business pack you and leave as did with Lafayette Square and Washington Square. Over the past 10 to 12 years, I remember going to the Indiana Black Expo Soul Picnic in Washington Park. Violence, gang fights and homicides ended that. My great grandmother still bears the scares on her leg from when she was trampled by a group of thugs running from gun fire from a rival gang. With hundreds of police offices downtown still multiple shootings, people getting shot downtown during Black Expo. A number of people getting shots or murdered at black clubs around the city like Club Six on the west side, The Industry downtown, Jamal Tinsley's shot out in front of the Conrad, multiple fights and shootings at the skating rinks, shootings at Circle Center Mall and shooting and robberies and car jackings at Lafayette Mall. Shootings and gang violence and the State Fair. I can go on and on and on. Now Broad Ripple. (Shaking head side to side) Say It Loud, I'm Black and I'm Ashamed.

  5. Ballard Administration. Too funny. This is the least fiscally responsive administration I have ever seen. One thing this article failed to mention, is that the Hoosier State line delivers rail cars to the Amtrak Beech Grove maintenance facility for refurbishment. That's an economic development issue. And the jobs there are high-paying. That alone is worth the City's investment.

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