The Safety and efficacy news section highlights information on reports of adverse drug reactions, with other news from around the world, including labelling changes. The Consultation documents section presents draft International Pharmacopoeia texts for comment.
A botanical drug product is intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans. A botanical drug product consists of vegetable materials, which may include plant materials, algae, macroscopic fungi, or combinations thereof.
The drug fights HIV when all other treatments fail. In Europe, where Fuzeon already is approved, the drug carries a breathtaking price tag -- about $20,500 per year.
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.
The PFDD initiative aims to more systematically obtain the patient perspective on specific diseases and their treatments. The patient perspective is critical in helping FDA understand the context in which regulatory decisions are made for new drugs.
The purpose of this webinar is to provide patient stakeholders with a background on the meetings under the Patient-Focused Drug Development initiative. This webinar is split into four modules, each focusing on a separate topic.
The drug, Opdivo (nivolumab), outperformed a standard chemotherapy, Afinitor (everolimus), in terms of shrinking tumors and boosting patient survival, the study found. It was to be presented Friday at the European Cancer Congress in Vienna, and is being published simultaneously in the New England Journal of Medicine.
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.