FDA

FDA approves Eli Lilly's injectable diabetes drug

September 18, 2014
Associated Press
The agency on Thursday cleared the drug, Trulicity, as a weekly injection to improve blood sugar control in patients with type 2 diabetes, which affects more than 26 million Americans.
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Testosterone drugs need study on heart risks, FDA panel says

September 18, 2014
Bloomberg News
Drugmakers, including Eli Lilly and Co., should conduct new trials to assess the heart risks of testosterone therapies used by millions of men last year, advisers to U.S. regulators said.
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Recent wins worth $4B to Lilly market value

September 15, 2014
J.K. Wall
Lilly is finally putting meat on the bones of its predictions about its experimental diabetes and cancer drugs. That gives investors the certainty they crave that Lilly’s future revenue won’t remain in its 2014 doldrums.
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Lilly says new insulin fares better than rival's in late-stage tests

September 4, 2014
Associated Press
The Indianapolis-based drugmaker said Thursday that peglispro produced statistically significant lower blood sugar levels in patients when compared to people who took the Sanofi insulin Lantus in two late-stage studies of people with type 1 diabetes.
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Lilly wins tentative approval for diabetes drug

August 20, 2014
 IBJ Staff
Final approval could be delayed until mid-2016 due to a claim of patent infringement by drugmaker Sanofi.
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Indy startup has rare disease in its sights

August 9, 2014
J.K. Wall
Founders of Chondrial Therapeutics believe that if further testing validates their treatment for Friedreich’s ataxia, it could be a blockbuster with annual sales topping $1 billion.
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FDA approves Lilly, Boehringer diabetes drug

August 1, 2014
Associated Press
The Food and Drug Administration said Friday it will permit Jardiance tablets to be used by adult patients with type 2 diabetes who also are trying to control their condition with diet and exercise.
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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.
More

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.
More

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.
More
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  1. Great article and post scripts by Mike L (Great addition to IBJ BTW). Bobby's stubborn as a mule, and doubt if he ever comes back to IU. But the love he would receive would be enormous. Hope he shows some time, but not counting on it.

  2. When the Indiana GOP was going around the State selling the Voucher bill they were promising people that the vouchers would only be for public charter schools. They lied. As usual.

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  4. Jim, your "misleading" numbers comment is spot on. This is the spin these posers are putting on it. News flash, fans: these guys lie. They are not publicly traded so no one holds them accountable for anything they say. The TV numbers are so miniscule to begin with any "increase" produces double digit "growth" numbers. It's ridiculous to think that anything these guys have done has awakened the marketplace. What have they done? Consolidate the season so they run more races on consecutive weekends? And this creates "momentum." Is that the same momentum you enjoy when you don't race between August and March? Keep in mind that you are running teams who barely make ends meet ragged over the summer to accomplish this brilliant strategy of avoiding the NFL while you run your season finale at midnight on the East Coast. But I should not obfuscate my own point: any "ratings increase" is exactly what Jim points to - the increased availability of NBC Sports in households. Look fans, I love the sport to but these posers are running it off a cliff. Miles wants to declare victory and then run for Mayor. I could go on and on but bottom line for God's sake don't believe a word they say. Note to Anthony - try doing just a little research instead of reporting what these pretenders say and then offering an "opinion" no more informed than the average fan.

  5. If he's finally planning to do the right thing and resign, why not do it before the election? Waiting until after means what - s special election at tax payer expense? Appointment (by whom?) thus robbing the voters of their chance to choose? Does he accrue some additional financial advantage to waiting, like extra pension payments? What's in it for him? That's the question that needs to be asked.

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