FDA
Lilly'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.
MoreFDA says potential diabetes drug may cause cancer
July 18, 2011
Bloomberg NewsDapagliflozin would be the first in a new class of diabetes treatments called SGLT2-inhibitors that work by letting patients
excrete excess blood sugar in their urine. Indianapolis-based Eli Lilly and Co. is among several companies pursuing similar
drugs.
MoreLilly, partner find no Bydureon effect on heart rhythm
June 27, 2011
Bloomberg NewsEli Lilly and Co., Amylin Pharmaceuticals Inc. and Alkermes Inc. said an analysis of a 148-patient trial found no evidence
that their experimental Bydureon diabetes drug causes prolonged heart rhythms.
MoreLilly drug to detect Alzheimer’s criticized by consumer group
May 11, 2011
Bloomberg NewsEli Lilly and Co.’s Amyvid, an experimental imaging agent to detect signs of Alzheimer’s disease in the brain,
shouldn’t be approved because of unreliable study results, a consumer-advocacy group said.
MoreTwo wins to bring Lilly modest sales
May 9, 2011
J.K. WallFinally, some new revenue. Eli Lilly and Co. will enjoy modest new sales later this year after U.S. regulators approved a
new diabetes drug developed by a partner company, and another company nears approval on a drug that will produce royalties
for the Indianapolis-based drugmaker.
MoreFDA OKs new diabetes pill from Lilly, Boehringer
May 2, 2011
IBJ Staff and Associated PressThe Food and Drug Administration says it has approved a new diabetes pill from Boehringer Ingelheim and Eli Lilly for patients
who can't control their blood sugar with older medicines.
MoreFDA wants further testing of Lilly pancreas drug
April 16, 2011
Associated PressEli Lilly and Co. Inc. said Friday that the FDA has asked the drugmaker to conduct another clinical trial of its proposed
pancreas drug before it resubmits an application to have the drug approved for sale.
MoreRegulators delay approval of Lilly's Alzheimer’s screen
March 18, 2011
Bloomberg NewsThe Food and Drug Administration said Lilly needs to create a training program to ensure brain scans are interpreted properly.
MoreLilly confident of FDA approval for Amyvid, Lechleiter says
March 9, 2011
Bloomberg NewsEli Lilly and Co. CEO John Lechleiter said he’s confident of gaining U.S. regulatory approval for a drug to help identify
plaque in the brain associated with Alzheimer’s disease.
MoreEndocyte again changes terms of public offering
February 4, 2011
IBJ Staff and Bloomberg NewsThe West Lafayette-based biopharmaceutical company now is planning to offer at least 12.5 million shares, or 17 percent more
than previously announced, but at a lower price of $6 each.
MoreLilly, Bristol-Myers halt enrollment in lung-cancer trial
February 2, 2011
J.K. WallEli Lilly and Co. and Bristol-Myers Squibb Co. stopped enrolling new patients in a clinical trial of an experimental lung
cancer drug over concerns about patients developing blood clots.
MoreLilly product gets boost; Wall Street yawns
January 26, 2011
J.K. WallEli Lilly and Co. probably will get approval for its newly acquired imaging agent used to diagnose Alzheimer’s disease,
but so far analysts are unimpressed.
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Why not exclude all places that cater to the rich. Private clubs should not have rules: rules are for the serfs only. In fact, we should subsudize the private clubs, they should not pay property or sales taxes. You go rich and powerful, rules are not for you.
Poor little LadyJ! Typical Democommie. In case it got past you, the dems have totally screwed this country in the past 3+ years. We have a democommie in the White House who apparently never read the Constitution, while claiming to be a constitutional scholar. We had a democommie-controlled Congress (opposite of PROGRESS?)passing bills that "we'll have to pass before we know what's in it". This impostor president has violated the U. S. Constitution too many times to count. The Attorney General is a race-baiting gunrunner that refuses to stop illegal immigration. And, the head of NASA, a once-proud agency that put several men on the moon, is now our liason to the murderous Muslims. Great job, democommies! Sometimes I wish they really would try to take our guns.
Pat Bauer try t do right about the state but the Republican leader and all of them did not think of us. Only the money they will get from their rich corporation. Of Course the Democrats had union, so I won't vote for Bosma or whatever his name is.
Well you are talking about Republican, did all of the Damage in this state. Sure the Democrats did some but most is the Republican. The Republican set us back not going forward. Hurry passed bills won't listen to any amendment our way only. The Republicans drew up these district so they could win again. Which is a crying shame. I will not vote for any Republican and I got the list who voted for the RTW Bill and who didn't. Tired of the Republicans
Actually, it was Greenspan who encouraged the elderly to refinance their homes, using their equity to boost the economy after 9/11. In addition, it was George Bush and Barney Frank who jointly suggested that everyone should hold a piece of the rock. It was the Bush Administration, namely Treasury Secretary Paulson who deregulated Wall Street and Lenders such as Countrywide, Washington Mutual, Wachovia, Bank of America, and Wells Fargo. When the TARP Bailout Proposal went to Capitol Hill in October 2008, Treasury Secretary Paulson asked for, and received, full immunity from future prosecution, dating back to his time as CEO of Goldman Sachs, the co-recipient of the initial $350 Billion Dollar Tarp Bailout Payment for Wall Street, back in October 2008. It was the US Treasury and the Federal Reserve, both controlled by the Bush Administration, that created sub-prime mortgages, starting in 2004. Many members of the House and Senate, on both sides of the aisle, benefited from home mortgage refinancing. Banks, appraisers, and realtors pushed people into home mortgages they had no business accepting, based on claims that the housing market would only get better. Average Americans did not create Credit Default Swaps, I think those creations happened on Wall Street. Spend some time at the library, you will be shocked by what your research brings forth.