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FDA
J&J wins OK for first in new class of diabetes drugs
March 31, 2013
Bloomberg NewsJohnson & 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.
MoreLilly, Boehringer submit diabetes drug to FDA
March 25, 2013
Associated PressEli 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.
MoreEndocyte stock sinks due to possible drug-filing delay
February 26, 2013
J.K. WallEndocyte 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.
MoreLilly aims to submit five new drugs for approval
February 4, 2013
J.K. WallWith 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.
MoreLilly competitor gets backing on diabetes drug
January 10, 2013
Bloomberg NewsJohnson & 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.
MoreCook wins approval for new stent
November 19, 2012
J.K. WallBloomington-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.
MoreLilly's Alzheimer's drug trials show mixed results
August 24, 2012
Bloomberg News, J.K. WallEli 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.
MoreFDA’s $6.4B drug review fee plan passes Senate
May 24, 2012
Bloomberg NewsThe 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.
MoreEli Lilly's Cialis faces faster-acting competition
April 30, 2012
IBJ Staff and Bloomberg NewsA 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.
MoreLilly receives Europe's OK for new Byetta use
March 23, 2012
IBJ Staff and Associated Press, Associated PressEuropean 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.
MoreFDA removes hurdle in Endocyte's path to drug approval
March 5, 2012
J.K. WallEndocyte 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.
MoreLilly's ex-partner wins FDA approval for diabetes drug
January 29, 2012
Bloomberg NewsAmylin 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.
MoreAt long last, Roche wins approval of Nano
January 16, 2012
J.K. WallThe 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.
MorePotential Lilly drug doubles good cholesterol
November 15, 2011
Bloomberg NewsEli 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.
MorePotential Effient rival shows promise in study
November 14, 2011
Bloomberg NewsA 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.
MoreLilly, Bristol-Myers approved to market wider Erbitux use
November 7, 2011
Bloomberg NewsEli 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.
MoreFDA approves first generic versions of Zyprexa
October 24, 2011
IBJ Staff and Associated PressFederal 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.
MoreLilly diabetes drug wins approval for expanded use
October 19, 2011
Bloomberg NewsEli 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.
MoreQ&A
October 17, 2011
J.K. WallSherry 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.
MoreFDA: Cook Medical’s stent met efficacy, safety goals
October 11, 2011
Bloomberg NewsPeripheral 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.
MoreFDA 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.
MoreDebate rages over whether Lilly's Byetta lifts cancer risk
September 16, 2011
Bloomberg NewsA German researcher disputed the validity of a study that found Byetta and another diabetes drug increase cancer risk.
MoreHealth regulatory leaders ready to flock to city
September 14, 2011
IBJ StaffThe 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.
MoreFDA gets new report on Lilly diabetes drug
September 12, 2011
Associated PressDrugmakers 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.
MoreFDA deal with drugmakers raises user fees 6 percent
September 1, 2011
Bloomberg NewsDrugmakers 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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See, I told u Indyman and Dipsicle....this 8 days is overkill. It's barely worth a weekend....great job Tony George! Your dream has been fulfilled....he fans want the I r l back. Thats how good it was.....and that sucked.
I have been in training for a short time now but right off I can see that safety and quality are the number one issues, my experience as of late has been a positive one, the employees along with Jeff the plant manager and the operation supervisor as well as the engineers are a highly motivated group of people, what an asset for the area to have and for company's in need of a quality metal products.
Pimlico
While I understand the severity of their actions as well as everyones eagerness to hold them responsible for thier lost funds, these gentlemen did know how to make money. Dispite thier poor decisions over the ownership of Fair they had made several wise investments which paid them greatly. This proves they do have the potential to rebuild so they can repay. I do not feel they should live the life of luxuary but given an opportunity could they find ways of repaying the debts? They are doing nothing now but being a burden on tax payers. Just a thought!!!!!
You guys have some "interesting" comments to say the least. I hope you will call in and share those opinions starting June 1. I'm looking forward to having you on the air.