We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Sponsors submitting pediatric study plans for a drug have several options to determine optimal dosing for children when no standard dosing information exists, according to an FDA draft guidance on clinical pharmacology in pediatric studies. Read More
The Republican landslide in the midterm election will put GOP lawmakers in the driver’s seat on the generics labeling rule, user-fee negotiations and agency funding, but experts say the political shift’s impact remains uncertain. Read More
Pharmaceutical companies today spend an average of $2.6 billion to get their products to market, according to a new report that finds R&D costs have increased 145 percent over the past decade. Read More
Companies developing vaginal microbicide gels to prevent HIV infections should have a scoring system to measure the presence and severity of rash, swelling, immune response and damage to local tissue in human studies evaluating the safety and tolerability of the products, says a new final guidance. Read More
Amgen and AstraZeneca said their experimental psoriasis compound brodalumab demonstrated better outcomes than Janssen’s therapy Stelara in a Phase III trial, a development that moves the drug one step closer to market in the competitive therapeutic area. Read More
Clinical trials of three experimental Ebola therapies are set to begin in West Africa next month with results due as soon as February, according to Doctors Without Borders. Read More
European regulators yesterday told the European Union ombudsman that they adhered to the law when allowing manufacturer AbbVie to redact information from its clinical study reports, marking the latest twist in the debate over European trial data transparency. Read More
The European Medicines Agency has lent its support to an initiative to qualify biomarkers that can provide an early warning on an investigational compound’s risks of causing drug-induced kidney injuries, an endorsement that researchers say is necessary to move to the next phase of development. Read More