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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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Saw the Indy Men's Chorus "Music of Gilbert & Sullivan" at the Indiana Historical Society on Sunday evening.
Temporary workers are not "tools" they are people and companies that keep large amounts of temp staff are cheating.
I miss having them around. I hope one of their stores is in the general Meridian/86th Street area. I will make good use of it.
The Fringe! Plus, the simple fact that there are so many local faves in such close proximity to each other.
I remenber, watching the toll road, being built, through South Bend, when I was 10 years old. I believe, back then that it was estimated, that the toll road, would be paid for in 20 years and then it would be free. I am now 71, what happened? Since the power is in the people, by that, I mean that, we the people are in total control of everything. I, suggest that no one ever use the toll road again, let it go broke. We the people can control the price of everything, from groceries to gas, if we would just do it. If we don't pay the asking price, the sellers will lower the price and if we wait awhile, they will lower the price to what we accept as reasonable. I would like to know why a highway like interstate 94, is so well maintained, a much better highway, than the toll road, but has no tolls. I would also like to know why, a sitting governor, with a term limit, maximum of eight years, can lease, public property, for 75 years. Even though I have transponders in both of my trucks and will not be affected by the increase, I have been and will contine to avoid using the toll road. I make many trips from northern Indiana to Chicago, every year, and I prefer the better highway, I94!