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FDA: 'Mistake' Not To Include Doctor At Eli Lilly Drug Panel

-(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 »

Dyax gets FDA panel recommendation on drug

Dyax Corp.
said Wednesday a Food and Drug Administration advisory panel recommended approval of the company’s developing treatment for a genetic condition that can lead to dangerous swelling.
The drug candidate is called DX-88 and is aimed at treating the condition called hereditary angioedema. While the FDA does not have to approve the drug, it usually follows the advice of its expert panels. The panel vote was slim, with six recommending approval Read the rest of this entry »

FDA Panel Gives Blessing to First Drug Manufactured in

,
,
The first drug ever manufactured in genetically-modified animals is likely coming soon to the U.S. market. A panel of expert advisers to the FDA
that an experimental anti-clotting product developed by Framingham, MA-based GTC Biotherapeutics looks safe and effective enough to become a marketed product.
, based on documents that were made publicly available Wednesday morning. The FDA still hasn’t made a final decision; its deadline Read the rest of this entry »

FDA Panel Assesses Lilly Blood Thinner

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 »

Governor's panel tours island recovery efforts

Published January 17, 2009
GALVESTON — Four months after Hurricane Ike made landfall, the members of the Governor’s Commission for Disaster Recovery and Renewal got a firsthand look at recovery efforts on the island.
They also heard what has become a common refrain from Mayor Lyda Ann Thomas: “We need more help.”
Thomas took advantage of her role as tour guide during a two-hour bus tour of some of the hardest hit areas of Galveston. She Read the rest of this entry »

Lilly Blood Thinner Gets FDA Panel Nod

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 »

Gulf War Research Panel Finds 1 In 4 Veterans Suffers From Illness

ScienceDaily (Nov. 17, 2008)
— At least one in four of the 697,000 U.S. veterans of the 1991 Gulf War suffer from Gulf War illness, a condition caused by exposure to toxic chemicals, including pesticides and a drug administered to protect troops against nerve gas, and no effective treatments have yet been found, a federal panel of scientific experts and veterans concludes in a landmark report released Monday.
The Congressionally-mandated Read the rest of this entry »

Panel to Review Health of Creek

County officials knew more than 14 years ago the creek was a special place. They vowed to protect its fragile ecosystem even as they allowed major development, including a new jail and dense housing, in nearby rural Clarksburg. But now they face a daunting challenge.
County scientists, in a detailed report that crunches thousands of bits of data about sediment and runoff, microscopic organisms, water speed and unhealthy chemicals, suggest that the Read the rest of this entry »

New Questions for Chairman of FDA Panel on BPA

Last week,
, who chairs a
panel on the chemical bisphenol-A, defended himself in an editorial in a Milwaukee newspaper against charges that he has been influenced by millions of dollars in donations to his research center by BPA makers.
Rep. Rosa DeLauro (D-Conn.)
, who heads a House panel that oversees FDA funding. In a letter sent to FDA today, DeLauro asked the FDA to delay the release later this week of its report on the safety of BPA, Read the rest of this entry »

Savient shares rise as FDA sets drug panel review

Shares of
rose Wednesday after the Food and Drug Administration announced a meeting to review the company’s treatment for the inflammatory disorder gout.
The agency’s panel of outside experts will meet March 5 to review the safety and effectiveness of the drug Puricase, known generically as pegloticase. FDA is not required to follow the panel’s advice, though it often does.
The East Brunswick, N.J.-based company’s stock rose 22 cents, or 3.7 Read the rest of this entry »