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
The new company will have four complementary businesses: Perfumery & Beauty, Food & Beverage/Taste & Beyond, Health, Nutrition & Care and Animal Nutrition & Health, each with strong market positions and expertise to address emerging consumer trends. The businesses will also prioritize environmental sustainability, health and well-being.
Merck (MSD) has signed a definitive agreement for the acquisition of all outstanding shares of Imago BioSciences for a total equity price of nearly $1.35bn. A clinical-stage biopharmaceutical firm, Imago focuses on the development of new therapies to treat myeloproliferative neoplasms (MPNs) and other bone marrow ailments.
Danish pharma Novo Nordisk has announced plans to invest 5.4 billion Danish kroner to expand its existing facilities in Bagsværd. The project will establish extra R&D capacity for manufacturing APIs to supply the company’s global clinical trials for oral and injectable products. The expansion is expected to be finished in 2024, creating about 160 new jobs.