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.
Despite industry concerns that ICH’s proposed new limits on metals are too strict, the organization released final guidance on elemental impurities in finished drugs that appears little changed from an earlier draft. Read More
Before wasting time and money on a clinical trial, sponsors should determine whether additional preclinical studies are needed to rule out a drug candidate’s potential for endocrine-related adverse effects, the FDA says. Read More
Amgen and Novartis have launched a neuroscience drug collaboration to develop and commercialize new inhibitors to fight Alzheimer’s disease and treat migraines. Read More
Allergan said Wednesday that results from two Phase 3 studies evaluating Avycaz in hospitalized adults with complicated urinary tract infections, including pyelonephritis, affirm the drug’s safety and efficacy. Read More
Patients who got a combination of GlaxoSmithKline’s Volibris and Eli Lilly’s Adcirca to treat pulmonary arterial hypertension had significantly less hospitalization, disease progression or death compared with those getting monotherapy in a Phase 3b/4 study, newly released data show. Read More