FDA

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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Lilly, Bristol-Myers approved to market wider Erbitux use

November 7, 2011
Bloomberg News
Eli Lilly and Co. and Bristol-Myers Squibb Co. won U.S. approval to expand marketing of the cancer drug Erbitux for late-stage head and neck tumors.
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FDA approves first generic versions of Zyprexa

October 24, 2011
 IBJ Staff and Associated Press
Federal health officials on Monday approved the first generic versions of the blockbuster drug Zyprexa, which posted sales of $5.7 billion last year for Indianapolis-based drugmaker Eli Lilly and Co Inc.
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Lilly diabetes drug wins approval for expanded use

October 19, 2011
Bloomberg News
Eli Lilly and Co. and Amylin Pharmaceuticals Inc.’s Byetta has received expanded approval for use with the world’s top-selling insulin to treat Type 2 diabetes.
More

Q&A

October 17, 2011
J.K. Wall
Sherry Keramidas, who earned her doctorate in neuroscience and physiological psychology from Purdue University, is executive director of the Maryland-based Regulatory Affairs Professionals Society, which is holding its annual conference Oct. 22-26 at the Indiana Convention Center.
More

FDA: Cook Medical’s stent met efficacy, safety goals

October 11, 2011
Bloomberg News
Peripheral vascular devices, including stents, angioplasty balloons and synthetic grafts, generated $4.3 billion in global revenue last year and may earn $5.6 billion in 2014.
More

FDA approves Cialis for enlarged prostate

October 7, 2011
Cialis, Lilly's blockbuster erectile dysfunction drug, now can be taken to treat enlarged prostate. FDA approval means men who suffer from both disorders can take one medication.
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Debate rages over whether Lilly's Byetta lifts cancer risk

September 16, 2011
Bloomberg News
A German researcher disputed the validity of a study that found Byetta and another diabetes drug increase cancer risk.
More

Health regulatory leaders ready to flock to city

September 14, 2011
 IBJ Staff
The top event for regulatory professionals in the health care industry is headed to Indianapolis next month. The annual conference of the Regulatory Affairs Professionals Society, or RAPS, is expected to draw thousands of members representing 120 companies and organizations.
More

FDA gets new report on Lilly diabetes drug

September 12, 2011
Associated Press
Drugmakers Eli Lilly and Co. and Amylin Pharmaceuticals Inc. said Monday that patients taking their potential once-weekly diabetes treatment, Bydureon, saw a significant improvement in cardiovascular risk factors.
More

FDA deal with drugmakers raises user fees 6 percent

September 1, 2011
Bloomberg News
Drugmakers including Eli Lilly an Co. have agreed with regulators on a 6-percent increase in review fees as part of reauthorizing the drug-approval process through fiscal 2017.
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  1. These higher rates Co. e about only because physicians are now hospital employees. otherwise physicians couldn't charge these rates and share the windfall with the hospital. Community/rural hospitals probably not buying physicians practices and thus weren't getting the windfall anyway.

  2. The incentive for poor people to get themselves off public assistance and "no longer be poor" is even with help...they're STILL POOR! Being poor, even with some assistance, isn't all that pleasant. (I speak from experience) It's a stubborn myth that poor people, who are on public assistance, are sitting in the lap of luxury. You should try living on just those "freebies" that you mentioned and see how meager they actually are. By the way, I didn't mean you had to buy/own a puppy...just pet one. :)

  3. As near as I can tell the minority has ZERO constitutional obligation to offer a quorum to the majority. A requirement for quorum was inserted into the constitution so that tyrannical majorities could not simply shove through odious and objectionable legislation (which is exactly what they did.) By allowing a tyrannical majority to charge fines against the minority for exercising their constitutional prerogative to deny quorum the court as made a mockery of constitutional governance in the state of Indiana.

  4. The voters elected the Reps to make a vote not walk out on the vote. They had to the right to exercise their opinion and vote "no" to the bill. Let me ask you this if you walked out of your job for 5 straight weeks would you get paid? Would you even have a job to go back to? If any elected official walks out on the people they should be arrested for stealing tax dollars from the public. They were elected to do a job and not leave when the job gets stuff.

  5. I have been to several of their locations in Pennsylvania and always go in for 1 item and leave with a basket full of things. I'm very happy they decided on Indiana, now if only they would put the other store in eastside.

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