FDA deal with drugmakers raises user fees 6 percent
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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FDA says potential diabetes drug may cause cancer
Dapagliflozin 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.
Lilly, partner find no Bydureon effect on heart rhythm
Eli 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.
Lilly drug to detect Alzheimer’s criticized by consumer group
Eli 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.
Two wins to bring Lilly modest sales
Finally, 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.
FDA OKs new diabetes pill from Lilly, Boehringer
The 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.
FDA wants further testing of Lilly pancreas drug
Eli 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.
Regulators delay approval of Lilly’s Alzheimer’s screen
The Food and Drug Administration said Lilly needs to create a training program to ensure brain scans are interpreted properly.
Lilly confident of FDA approval for Amyvid, Lechleiter says
Eli 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.
Endocyte again changes terms of public offering
The 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.
Lilly, Bristol-Myers halt enrollment in lung-cancer trial
Eli 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.
Lilly product gets boost; Wall Street yawns
Eli 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.
Lilly imaging drug fails to win FDA panel’s backing
Eli Lilly and Co.’s Amyvid isn’t ready to be approved to detect Alzheimer’s-related deposits in the brain, according to FDA advisors. The medicine could still be approved if Lilly establishes a training program and a way to ensure that the results of brain scans are read consistently, they said.
FDA panel sees promise in Lilly imaging drug
A federal panel of medical experts said Thursday a first-of-a-kind imaging chemical designed to help screen for Alzheimer's disease could be useful pending additional study and training for physicians.
Carmel firm gets FDA approval for lice treatment
ParaPRO LLC’s treatment, called Natroba, has a potential U.S. market of 6 million to 12 million infected children annually.
Lilly imaging drug isn’t ready for approval, FDA says
Eli Lilly and Co.’s experimental drug to help identify plaque in the brain tied to Alzheimer’s disease isn’t ready for approval, according to U.S. regulators.
Panel says Lilly’s Solpura isn’t ready for approval
Eli Lilly and Co. failed to win an FDA advisory panel’s recommendation to introduce the first pancreatic enzyme that isn’t derived from pig parts.
Lilly partner moves up timetable for diabetes drug
Amylin Pharmaceuticals Inc., rebuffed twice in its bid for U.S. approval of a weekly diabetes drug, will meet its timetable and submit a heart-safety study to regulators by the end of 2011, its CEO said.
Lilly’s Solpura may lack data to prove effectiveness
Outside advisers to the FDA will meet Jan. 12 to review whether the drug should be approved for people with pancreas insufficiency caused by cystic fibrosis, chronic pancreatitis or other conditions.
Lilly, other big drugmakers shut out by FDA in 2010
Regulators cleared 21 medicines, the fewest since 2007, for sale last year. It was the first time in a decade that Pfizer Inc., the world’s largest drugmaker, as well as Lilly, Merck & Co. and Bristol-Myers Squibb Co. were shut out at the same time, according to agency records.