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.
FDA
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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.
Lilly sues to block copy of Evista osteoporosis drug
Watson Pharmaceuticals filed for FDA approval to sell a low-cost version of Eli Lilly and Co.’s osteoporosis medicine. Indianapolis-based
Lilly is seeking a court order that would block approval until three of its patents expire in 2017.
Lilly diabetes drug may have cancer risk, FDA says
Once-weekly form of Byetta is awaiting the FDA’s OK. Analyst predict the new version of the drug, if approved, could rack
up sales of $2 billion annually.
Louisiana gets $20M in Lilly drug settlement
Louisiana was one of 13 states that filed individual suits in state courts over allegations that Lilly pushed Zyprexa for
uses that had not been approved by federal regulators.
Indiana food manufacturers ramp up safety precautions
The peanut-borne salmonella outbreak of 2009 raised awareness about the risk of illness from unlikely sources. Unfortunately,
that wasn’t the last time a seemingly innocuous ingredient made people sick, and prompted recalls.
Lilly sues to block generic of Adcirca lung treatment
Netherlands-based Synthon Pharmaceuticals is seeking U.S. Food and Drug Administration approval to sell a copy of the medicine.
FDA says ‘not yet’ on Lilly’s once-weekly Byetta
Regulators won’t require more time-consuming tests of the drug, but want Eli Lilly and Co. and its partners to clarify labeling,
manufacturing
processes.
Lilly settles Arkansas Zyprexa suit for $18.5M
Arkansas Attorney General Dustin McDaniel on Tuesday announced an $18.5 million settlement of a lawsuit with Eli Lilly &
Co. over off-label marketing of the anti-psychotic drug Zyprexa.
Pfizer’s Viagra patent partially rejected in Lilly fight
The patent on impotence drug Viagra was partially rejected after the U.S. Patent and Trademark Office said it wasn’t different
enough from a Chinese herb known as Horny Goat Weed. The patent was key to an infringement suit Pfizer filed in 2002 against
Eli Lilly and Co. over its rival Cialis drug.
Lilly shares get boost from OK of rival’s drug
Shares of Lilly and partner Amylin rose on hopes that their new version of Byetta will be approved following U.S. regulators’
clearance of a similar drug.
Biotech firm plans $28M Greenwood plant
Greenwood pharmaceutical firm Elona Biotechnologies plans to build a $28 million production facility and create 70 jobs to
help develop a cheaper form of insulin that could gain significant market share.
FDA letters scold Lilly, others over marketing materials
The letter to Indianapolis-based Lilly cites a print advertisement for the antidepressant Cymbalta that did not adequately
display information about the drug’s side effects.
FDA cancels meeting to review Lilly’s Cymbalta
The agency said the meeting was canceled “to allow time for the FDA to review new information” about a proposed new use for
the drug.
Lilly wins approval for long-acting Zyprexa
Once-a-month injection of best-selling drug will have patents that could extend until 2018.