As revealed by WellDoc, Inc. on Wednesday, it had entered into a commercial agreement with Johnson & Johnson (NYSE:JNJ) LifeScan, Inc. to provide digital health solutions for patients with Type 2 diabetes.
Under the commercial partnership, the BlueStar diabetes management platform and smartphone app, the first digital health solution approved by the US Food and Drug Administration (FDA) for patients with type 2 diabetes, WellDoc will be integrated with the OneTouch Verio Flex blood glucose monitoring device with built-in Bluetooth Smart Technology and the OneTouch Reveal digital platform of LifeScan. The resulting integration aims to come up with a comprehensive Type 2 diabetes management program.
According to Kevin McRaith, WellDoc CEO, a national implementation of the said program is underway to help improve millions of lives suffering from Type 2 diabetes in the US through cost-efficient solutions.
Johnson & Johnson Janssen Vaccines & Prevention BV Completes Emergency Use Assessment and Listing (EUAL)
In other news, Johnson & Johnson Janssen revealed on Monday that it had completed its EUAL submission to the World Health Organization (WHO) for its investigational preventive Ebola prime-boost vaccine regimen.
In the past 40 years, 25 Ebola outbreaks have already been reported. The first Ebola outbreak occurred in 1976 in Congo. The most recent Ebola outbreak in West Africa has resulted in a mortality rate seven times higher than all past Ebola outbreaks have led to.
Paul Stoffels, M.D., Johnson & Johnson Chief Scientific Officer, has noted that action must be taken to prevent such outbreaks from happening again. Part of that action is making way for the availability of a safe and effective Ebola vaccine.
The approval of an EUAL designation for an investigational preventive vaccine highly depends on available data relating to its immunogenicity, safety, quality, and risk-benefit dynamics. Should the investigational preventive vaccine against Ebola be granted an EUAL, it can play a crucial role in effectively preventing a rapid outbreak.
It is important to note, however, that an EUAL permits the deployment of an investigational preventive vaccine during a critical emergency situation or outbreak but it does not guarantee actual regulatory review and approval.