The second issue for 2010 features an overview of WHO Prequalification Programmes in the areas of diagnostics, medicines and vaccines. This follows with a report from the WHO Prequalification of Medicines Programme concerning inspection of finished pharmaceutical product manufacturers.
The drug -- pimavanserin -- appears to significantly relieve these troubling symptoms, according to the results of a phase 3 trial to test its effectiveness. Their study was published in the Nov. 1 online issue of The Lancet and funded by Acadia Pharmaceuticals, the makers of pimavanserin.
Under the law, FDA must make sure that these treatments are safe and that for most people the drugs will not cause harm. "What we need to do is make drugs as safe as possible," says FDA Deputy Commissioner and Chief Medical Officer Janet Woodcock, M.D.
WebMD News Archive April 26, 2002 -- Millions of diabetics now take the drug Avandia in an effort to lower their blood sugar. Now a review conducted by Avandia manufacturer Glaxo SmithKline, offers the best evidence yet that the newer drug does not cause liver problems.
New research shows the drug strontium ranelate can cut the risk of vertebral fractures by nearly half in postmenopausal women with osteoporosis. Vertebral fractures -- or breaks in the small bones that make up the spine -- are a common and potentially disabling complication of osteoporosis.
European biotechnology companies making presentations included Discuva, Bioversys and Morphochem. Moreover, Melinta's new antibiotic, a fluoroquinolone, is currently in phase III clinical studies, whilst its drug discovery platform includes compounds against the most resistant pathogens.
Avycaz is a fixed-combination drug containing ceftazidime, a previously approved cephalosporin antibacterial drug, and avibactam, a new beta-lactamase inhibitor. As part of its QIDP designation, Avycaz was given priority review, which provides an expedited review of the drugs application.
That is the finding from a new report funded by the U.S. government's Agency for Healthcare Research and Quality (AHRQ). They noted that there was not enough data to determine if the bisphosphonates were better for preventing fractures than hormone-based treatments.