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.
The Food and Drug Administration said Lilly needs to create a training program to ensure brain scans are interpreted properly.
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.
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.
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.
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.
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.
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.
ParaPRO LLC’s treatment, called Natroba, has a potential U.S. market of 6 million to 12 million infected children annually.
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.
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.
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.
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.
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.
Eli Lilly and Co. and Amylin Pharmaceuticals Inc. said Wednesday they are asking the Food and Drug Administration to expand approval for their type 2 diabetes drug Byetta, which could bolster sales as the companies try to get approval for a new, longer-lasting version of the drug.
Eli Lilly and Co. said the Food and Drug Administration will perform a faster review of florbetapir, an imaging agent that may help diagnose Alzheimer's disease.
The companies believe the underarm testosterone solution has the potential to realize sales of more than $1 billion a year in the United States.
The Food and Drug Administration has cleared Cymbalta for musculoskeletal pain such as arthritis and chronic lower back conditions, which could mean another $500 million in annual sales for Lilly, an analyst estimates.
CEO John Lechleiter claims Eli Lilly and Co. isn’t interested in big acquisitions to bolster its flagging drug pipeline, but its recently devalued partner Amylin Pharmaceuticals might be the right fit, industry analysts say.
Stock in Eli Lilly and Co., Amylin Pharmaceuticals Inc. and Alkermes Inc. dropped after they were rebuffed a second time in a bid to gain U.S. approval of a once-weekly version of the diabetes drug Byetta.
