-(Dow Jones)- U.S. federal regulators on Monday acknowledged it was
a mistake to “dis-invite” a leading cardiologist to a panel that was deciding
whether to recommend approval for a controversial anti-clotting drug made by
Eli
Lilly & Co.
(LLY).
Dr. Sanjay Kaul, a cardiologist at Cedars-Sinai Heart Institute in
, was scheduled to participate in a
Feb. 3
Prasugrel, an anti-clotting drug that has been linked
to dangerous internal bleeding. Read the rest of this entry »
For the last six years,
’s blood thinner Plavix has enjoyed a near monopoly in the market for oral medications meant to prevent clots in patients who are at risk for heart attacks and strokes.
That monopoly status could be threatened, if the
. Tuesday afternoon, an advisory panel may recommend that the F.D.A. grant that approval.
Plavix had global sales of $7.3 billion in 2007, making it the world’s second best-selling drug after Read the rest of this entry »
(Adds analyst reaction beginning in seventh paragraph and updated stock
price.)
Eli Lilly & Co.
(LLY) expects to swing to a profit in
2009 from an anticipated loss in 2008 but sees sales growth slowing due to less
favorable currency exchange rates as well as generic competition for one of its
cancer drugs.
$6.5 billion
acquisition of ImClone Systems would result in a large charge for the fourth
quarter, causing the full-year net loss. The Read the rest of this entry »
Eli Lilly & Co.
(LLY) drug used to treat severe sepsis after
a recent study suggested the drug could increase the risk of serious bleeding
and death.
In a so-called “early communication” posted Wednesday on the FDA’s Web site,
the agency said it was working with Lilly “to further evaluate the incidence of
serious bleeding events and mortality in patients who received Xigris.”
Sepsis is a potentially life-threatening condition that occurs when Read the rest of this entry »
rose into the close Tuesday after an FDA unanimously recommended approval of its anticlotting agent prasugrel.
The nine members of the Food and Drug Administration’s cardiology panel said the new blood thinner, which Lilly developed with Japanese drugmaker
, is a significant improvement over its forebears for preventing blood clots in patients with heart problems.
Lilly had asked the panel to specifically evaluate prasugrel in patients requiring Read the rest of this entry »
WASHINGTON (AP) — Federal health officials said Friday a blood thinner from Eli Lilly offers life-saving benefits over drugs currently on the market, though its use may have to be restricted due to bleeding side effects.
The Food and Drug Administration is reviewing the highly anticipated drug, called prasugrel, as a therapy for patients with acute heart problems such as heart attacks, who face increased risk of blood clots. Lilly developed Read the rest of this entry »
Published: February 02. 2009 12:01AM
WASHINGTON — Federal health officials said Friday a blood thinner from Eli Lilly offers lifesaving benefits over drugs currently on the market, though its use may have to be restricted due to bleeding side effects.
The Food and Drug Administration is reviewing the highly anticipated drug, called prasugrel, as a therapy for patients with acute heart problems such as heart attacks, who face increased risk of Read the rest of this entry »
Eli Lilly & Co. said Wednesday the Food and Drug Administration is withholding approval on the long-acting version of schizophrenia treatment olanzapine.
The FDA is not requiring additional studies and the company said it is preparing a risk evaluation and mitigation strategy, to be submitted in the near future.
“We cannot speculate on the timing of a potential decision, but remain confident that, if approved, the long-acting depot formulation Read the rest of this entry »
,
Nov. 24
) Health
Education Answers, an interactive online program, has received Health
Information Product Certification from the National Committee for Quality
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Health Tools certification options. NCQA is a private, non-profit organization
dedicated to providing health care quality information through the Web and the
media in order to help consumers, employers, and others Read the rest of this entry »
U.S. regulators are “very far along” in their review of
Eli Lilly & Co.’s
(
LLY) application to market an experimental anti-clotting drug, prasugrel, Chief
Executive
said Thursday.
But Lechleiter, during on a conference call with analysts Thursday, didn’t
provide any more specific projection of when the Food and Drug Administration
might make a decision.
Sept. 26
, but that the review was very far
along. Analysts believe prasugrel could Read the rest of this entry »