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The FDA is maintaining the clinical hold it imposed Nov. 3 on VaxGen’s Phase II clinical trial for its next-generation anthrax vaccine, the company announced.
Device firms can avoid regulatory violations and move their products into the market sooner by building quality systems (QSs) into their clinical trials, according to an FDA official.
Clinical trial results for Wyeth’s and Solvay’s bifeprunox show that the drug maintains stability in patients with stable schizophrenia and improves symptoms in patients with acute schizophrenia, Wyeth announced. Read More
More than one out of seven members of institutional review boards (IRBs) have reviewed at least one protocol in the previous year under circumstances that “could be considered conflicts of interest,” according to the results of a survey published in the New England Journal of Medicine. Read More
VaxGen said HHS’ Office of Public Health Emergency Preparedness has imposed Dec. 18 as the new deadline for the company to begin its next Phase II clinical trial for its next-generation anthrax vaccine, although the FDA put a clinical hold on the trial. Read More
A newly published clinical study suggests that a drug-coated balloon treatment may be a viable alternative to stenting to counter recurrent in-stent restenosis the re-narrowing of the coronary artery after stent surgery to expand it. Read More
Fourteen years after silicone gel-filled breast implants were pulled from the market due to safety concerns, the FDA Nov. 17 announced it had approved marketing for two brands of the devices. Read More
The European Commission (EC) approved the first diabetes drug in a new class to control glucose levels and possibly reduce weight, Eli Lilly announced. Read More