Two Maryland-based companies are racing to get a vaccine for respiratory syncytial virus to market--and one just picked up a regulatory boost.
An Investigational New Drug application for WuXi PharmaTech and MedImmune's novel anti-IL6 monoclonal antibody for rheumatoid arthritis was accepted for review by the China Food and Drug Administration, the company said this week, marking a milestone in a development partnership started less than three years ago.
AstraZeneca wants to build up its oncology presence, and its latest acquisition could help the company on its way. The drugmaker's MedImmune division shelled out $150 million upfront and additional milestone payments for Definiens, a diagnostic outfit with imaging technology that identifies biomarkers in tumor tissue and provides a more accurate way to assess tissue samples.
Inovio Pharmaceuticals, AstraZeneca's MedImmune and the University of Pennsylvania have joined forces to study influenza and antibiotic-resistant bacteria, drawing on $12.2 million in federal funds.
It's one step back, one step forward for AstraZeneca's key respiratory drug benralizumab.
AstraZeneca was forced to concede a clinical defeat on Monday, noting that one of its top respiratory drugs in the clinic failed a study for severe chronic obstructive pulmonary disease. But while investigators also flagged a higher rate of adverse events for benralizumab than the placebo arm, the pharma giant shows no signs of backing away from a treatment it's billed as a potential $2 billion per year product.
AstraZeneca has launched a Phase III test of its targeted IL-13 asthma drug tralokinumab, beefing up its late-stage pipeline for respiratory diseases and squaring off against some major league competition now in the clinic.
Drugmakers cheer when influential doctors' groups revise treatment guidelines to include new drugs. But as AstraZeneca's MedImmune unit knows, those groups can backpedal.
AstraZeneca's flu vaccine sales may have just gotten a boost, courtesy of federal regulators. Wednesday, they recommended that healthy children 2 to 8 years old receive the company's nasal spray flu vaccine FluMist in lieu of flu shots when available.
Roche's Ventana Medical Systems and MedImmune said they will jointly develop an assay to help test a MedImmune immunotherapy for non-small cell lung cancer.