Merck has begun its rolling submission to seek the FDA's approval for its biologics license application for Ebola vaccine V920, or rVSVΔG-ZEBOV-GP, live attenuated. The filing is expected to be completed in 2019.
AstraZeneca granted Swedish Orphan Biovitrum marketing rights to infectious disease drug Synagis, or palivizumab. Under the terms of the deal, AZ will receive $1.5 billion upfront plus milestone payments tied to sales.
The European Parliament has approved a revised Renewable Energy Directive, confirming new targets for renewables, second-generation biofuels and energy efficiency. The directive will require renewables to account for 32% or more of the EU's gross final energy consumption and second-generation biofuels to provide 14% or more of transportation fuel by 2030.
The Department of Defense has awarded Ziehm Imaging a $135 million contract to provide the Army, Air Force, Marine Corps, Navy and federal civilian agencies with radiology systems, training and accessories. Fifty bidders competed for the five-year base contract, which comes with one five-year option period.
Baxter has increased its total authorized share repurchases to around $3.4 billion after its board approved $2 billion more in stock buybacks. The company also presented positive results from studies of its Floseal and Hemopatch products.
India-based Core Diagnostics has agreed to market Guardant Health AMEA's Guardant360 comprehensive liquid biopsy test in India for undisclosed terms. The assay detects cell-free circulating tumor DNA from 73 genes in blood samples collected from patients with advanced solid-tumor cancer.
A collaborative research agreement, valued at around $26.4 million, has been reached by Johnson & Johnson's Vision business, the Singapore Eye Research Institute and the Singapore National Eye Centre in hopes of improving myopia treatments. The partnership will promote research on myopia, interventions and predictive tools for identifying high-risk individuals for high myopia.
The FDA has granted Bio2 Technologies approval to start enrollment of patients for an investigational device exemption study of its Vitrium device. The randomized, controlled, noninferiority pivotal trial will assess the device's safety and effectiveness as a cervical interbody fusion device with a 12-month endpoint.