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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
Exelixis expects to submit an NDA by the end of this year for cabozantinib to treat advanced renal cell cancer, following the receipt of FDA breakthrough therapy designation for use in patients who have received one prior therapy. Read More