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This morning we learned that the FDA has issued another "approvable" letter to Pozen and GlaxoSmithKline for their migraine drug Trexima over safety concerns. POZN shares are down big. The company has scheduled a conference call for 11 a.m. ET. This is the third regulatory stumbling block for this drug and puts it on a timeline now where it could end up competing...
An independent advisory panel told the U.S. Food and Drug Administration that GlaxoSmithKline's widely used diabetes pill Avandia increased heart risk but the drug should remain on the market.
As a big FDA Advisory Committee meeting is taking place here in Gaithersburg, Maryland on the safety of GlaxoSmithKline's Avandia, the head of the agency has been named in a separate lawsuit. A non-profit group calling itself "CareToLive" is suing FDA Commissioner Dr. Andrew von Eschenbach over the recent delay in the potential approval of Dendreon's Provenge.
I think I just killed a tree. This morning I printed out the GlaxoSmithKline and FDA documents that were posted on the agency's Web site ahead of the advisory committee meeting on Avandia safety next Monday. About 700 pages! Nearly as many pages as the new "Harry Potter" book, but not nearly as entertaining.
A new study of health insurance records of more than 400,000 U.S. diabetics found no higher risk of heart attacks with GlaxoSmithKline Plc's pill Avandia when compared with other oral diabetes drugs, the drugmaker said in documents made public Thursday.
U.S. regulators should wait for final survival data before deciding whether to approveGPC Biotech proposed prostate cancer pill Orplatna, an advisory panel said on Tuesday in a 12-0 vote.
The FDA is seeking a one-year study of how the drug Pristiq affects the heart and liver, said Wyeth's chief medical officer, Dr. Gary Stiles.
People should immediately throw away more than 90 different products, from chili sauce to corned beef hash to dog food, produced at a plant linked to a botulism outbreak, the government warned Monday.
U.S. drug reviewers will ask an advisory panel if they should wait for more data before deciding whether to approve GPC Biotech proposed prostate cancer pill, a summary released Friday said.
President Bush established a high-level government panel to recommend steps to guarantee the safety of food and other products shipped into the United States and to improve U.S. policing of those imports. The White House denied the effort was aimed primarily at China.
Philippine authorities tested more Chinese products Wednesday after ordering several candy and cookie brands found to be tainted with an embalming chemical to be withdrawn from stores, the country's food safety watchdog said.
Shares of Imclone Systems fell after the company announced that phase III studies of its cancer drug Erbitux failed to meet the end point of progression free survival of non-small cell lung cancer.
The U.S. imports approximately 15% of its food -- and China is its third largest supplier. This week, China admitted it needs to raise food safety standards to international levels, amid the recent controversy of tainted Chinese foods. Chris Waldrop, director of the food and policy institute at the Consumer Federation of America, and Michael Doyle, director of the center for food safety at the University of Georgia, discussed the situation on “Power Lunch.”
A senior scientist at Consumers Union told "Squawk Box" that the U.S. regulators need to step-up inspections of food coming from China, particularly seafood.
Federal health officials said Thursday that they were detaining three types of Chinese fish -- catfish, basa and dace -- as well as shrimp and eel after repeated testing has turned up contamination with drugs unapproved in the United States for use in farmed seafood.
Pfizer said after markets closed Wednesday that U.S. health regulators will approve its novel AIDS drug called maraviroc once certain conditions have been met, although the world's biggest drugmaker did not elaborate on what was necessary to obtain an outright approval.
Gilead Sciences shares rose in aftermarket trading on Friday after the U.S. Food and Drug Administration approved the drugmaker's treatment for high blood pressure in the lungs.
Investors wiped some 6 billion euros ($7.97 billion) off the market value of French pharmaceutical company Sanofi-Aventis Thursday after U.S. federal health advisers rejected its Accomplia weight-loss drug.
GlaxoSmithKline faces a U.S. investor lawsuit claiming that Europe's biggest drugmaker misled shareholders about the safety of diabetes drug Avandia.
Turning the tables on the United States amid growing worries over dangerous Chinese products, Beijing said Friday some health supplements and raisins imported from the U.S. failed to meet China's safety standards and have been returned or destroyed.