The U.S. Food and Drug Administration has declined to immediately approve
Eli
Lilly & Co.’s
(LLY) application to market a long-acting formulation of its
antipsychotic Zyprexa.
said Wednesday the drug maker received a
so-called complete response letter from the FDA. Such letters typically mean the
FDA isn’t yet ready to approve a drug candidate. Lechleiter disclosed receipt of
the letter at a Goldman Sachs investor conference in
, which was
broadcast Read the rest of this entry »

NEW YORK (MarketWatch) — Eli Lilly & Co.
,
,
said Friday it has withdrawn its new-drug application to the U.S. Food & Drug Administration for its chronic-pain medication Cymbalta. The Indianapolis pharmaceutical company said it intends to resubmit application in the first half of next year with additioal data from a recently completed study in chronic osteoarthritis pain of the knee. “This was a difficult decision, but we believe the updated Read the rest of this entry »

CHICAGO (Reuters) – Eli Lilly and Co (LLY.N:
,
,
,
) said on Friday it withdrew an application to market its anti-depressant Cymbalta for the management of chronic pain because U.S. health regulators raised questions about the drug’s effectiveness and dosing.
Lilly said it made its decision to pull the supplemental New Drug Application for Cymbalta, or duloxetine HCl, after U.S. Food and Drug Administration reviewers questioned the design Read the rest of this entry »

(RTTNews) - 
Drug maker Eli Lilly & Co. (LLY:
) and Japan’s Daiichi Sankyo Co. Ltd. announced late Thursday that new drug application or NDA for prasugrel is still under review, with discussions continuing with the U.S. Food and Drug Administration or FDA. The companies confirmed that they have not been notified of any regulatory action for the NDA or of any decision to have an advisory committee to review prasugrel.
Read the rest of this entry »

Once again, a drug has won approval in Europe before the U.S. This time, it’s the anticlotting drug prasugrel from Eli Lilly and Daiichi Sankyo. The companies
that the drug has been greenlighted in Europe for certain patients who have stents put in to clear the arteries around the heart.
The drug, marketed under the name Efient, will compete with the blockbuster Plavix, which is co-marketed by Bristol-Myers Squibb and Sanofi-Aventis.
when Read the rest of this entry »

) will be running any more “Coming Soon” ads–like the one posted here for its late-stage experimental bloodthinner Effient–for drugs that haven’t been approved yet by the Food and Drug Administration.
Given the unpredictable nature of the agency and its post-Vioxx safety consciousness, biopharmaceutical companies just can’t count their chickens before they hatch.
(a publication that follows the drug industry, not to be confused with stocks that Read the rest of this entry »

Rockville, MD
– Prior to the February 3, 2009
(Lilly/Daiichi Sankyo), the drug’s sponsor called the agency to question the inclusion of
(Cedars-Sinai Medical Center, Los Angeles, CA) on the Cardiovascular and Renal Drugs Advisory Committee,
has learned.
In an interview today, FDA officials insisted that the call from Lilly had no bearing on their decision to exclude Kaul but acknowledged “mistakes” were made.
The agency received a phone Read the rest of this entry »

This press release contains forward-looking statements about Amylin and
Lilly. Actual results could differ materially from those discussed or implied
in this press release due to a number of risks and uncertainties, including
the risk that BYETTA and the revenues generated from BYETTA may be affected by
competition; unexpected new data; safety and technical issues; clinical trials
not confirming previous results; pre-clinical trials not predicting Read the rest of this entry »

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bloodthinner called Effient. The agency usually, but not always follows the advice of its outside panels of experts. If the FDA says yes, the drug would compete with Plavix from
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.
If you’ve never attended or listened to one of these panel meetings, many of them can be real yawners. It’s not uncommon to spot people in the audience taking a siesta. The committees typically take tremendously deep dives into Read the rest of this entry »

A Healthy You! — America’s Guide to Healthy Living is aimed at addressing
the effects of poor health in our country. The book is available in English
and Spanish and includes an extensive listing of specific resources in each
state where people can access useful programs and agencies in their area.
Lilly teamed up with the National Council of La Raza, the largest national
Latino civil rights and advocacy organization in the United States, to Read the rest of this entry »