Johnson and Johnson’s experimental two-stage vaccine for protection against Ebola virus disease is among eight medicines backed by the European Medicines Agency’s human medicines committee (CHMP) at its May meeting.
The vaccine, developed by J&J group Janssen, provides active immunisation to prevent Ebola virus disease (Zaire ebolavirus species) in individuals aged one year and older.
It consists of two components, Zabdeno (Ad26.ZEBOV), which is given first, and Mvabea (MVA-BN-Filo), given around eight weeks later.
Zabdeno and Mvabea received a positive opinion for marketing authorisations under exceptional circumstances ‘because the applicant was able to demonstrate that it is not possible to conduct a randomised controlled study that might generate comprehensive clinical data on the efficacy of the new Ebola vaccine even after authorisation’, the agency noted.
Elsewhere, the following medicines also took giant leap closer to EU approval:
By: Selina McKee
Source: Pharma Times
Novo Nordisk has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has provided a positive opinion for the company’s Sogroya therapy. The once-weekly treatment – also known as somapacitan – is for the replacement of endogenous growth hormone (GH) in aged children three years and older.
Medtronic is set to acquire EOFlow, the South Korea-based maker of an insulin patch pump. In its announcement of the deal Thursday, Medtronic suggested that integrating the tubeless device with its own continuous glucose monitors and meal-detection algorithm could create a new closed-loop system for largely hands-off diabetes management.
Apnimed started the year by bagging nearly $80 million in extended series C funds and the momentum has kept up, with the sleep-apnea-focused biotech nailing its goals in a phase 2 study. “For those who cannot tolerate current treatments, AD109 has the potential to be a convenient, oral pill that could improve people’s quality of life both at night and during the day.”
