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.
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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.
Amylin and Lilly seek expanded Byetta approval
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.
Lilly Alzheimer’s imaging agent to get priority FDA review
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.
Lilly, Acrux receive FDA approval for Axiron
The companies believe the underarm testosterone solution has the potential to realize sales of more than $1 billion a year in the United States.
Lilly wins approval of antidepressant Cymbalta for pain
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.
Analysts: Lilly setbacks might spur shopping spree
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.
UPDATE: Lilly, others see stock slide after drug rejection
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.
FDA demands more tests on new Lilly diabetes drug
Eli Lilly and Co. will have to wait at least 18 months and conduct more studies before it wins market approval of a once-weekly version of diabetes drug Byetta, a potential billion-dollar drug.
Lilly falls short on ‘field goal’ attempt
Eli Lilly and Co.’s “miss” on a new use for its cancer drug Alimta was a rare failure to get an existing drug approved for a new use—even though the company has struggled mightily to get entirely new drugs to market.
Endocyte’s $86M IPO plan a boon for Indiana, investors
Venture capitalists in Indiana and nationally have thrown money at the company with abandon. Local investors include CID Capital,
Clarian Health Ventures and the Indiana Future Fund.
Lilly gains panel’s backing to expand Cymbalta use
Outside advisers to the Food and Drug Administration voted 8-6 Thursday in favor of a broader use of Cymbalta on the basis
of studies in lower back pain and osteoarthritis of the knee.
Lilly’s Cymbalta helps chronic pain in U.S. review
Approval for the millions of Americans with chronic back or knee pain may add more than $500 million, or 16 percent, to Cymbalta’s
annual sales.
Lilly grows Alimta’s sales by shrinking market
In 2008, Eli Lilly and Co. asked drug regulators to change the label on Alimta so Lilly could no longer promote it as a treatment
for all patients suffering from non-small-cell lung cancer, but for only about 70 percent of the patients. Since then, sales
of the drug have accelerated, growing a whopping 48 percent last year.
Judge rejects controversial Guidant plea agreement
The deal included a $296 million criminal fine, but no charges against executives who failed to properly report problems with the company's defibrillators.