Sector News

New vaccine for Ebola among CHMP recommendations

June 2, 2020
Life sciences

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:

  • MYR’s Hepcludex (bulevirtide), for the treatment of chronic hepatitis delta virus infection in adult patients with compensated liver disease. Because there are no treatments currently approved for hepatitis D;
  • Novartis’ Piqray (alpelisib)for the treatment of locally advanced or metastatic breast cancer with a PIK3CA mutation.
  • Roche’s Rozlytrek (entrectinib; conditional marketing authorisation), for the treatment of patients whose solid tumours have a neurotrophic tyrosine receptor kinase gene fusion, or patients with ROS1-positive advanced non-small cell lung cancer;
  • Nabriva Therapeutics Ireland’s Xenleta (lefamulin)for the treatment of community-acquired pneumonia in adults;
  • Accord Healthcare’s biosimilar Zercepac (trastuzumab)for the treatment of breast and gastric cancer; and
  • Accord’s generic Apixaban Accord (apixaban)for treatment and prevention of venous thromboembolic events in adult patients and for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation.

By: Selina McKee

Source: Pharma Times

comments closed

Related News

November 27, 2022

DSM-Firmenich nutrition and beauty mega-merger edges closer as companies announce Exchange Offer

Life sciences

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.

November 27, 2022

Merck agrees to acquire Imago for $1.35bn

Life sciences

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.

November 27, 2022

Novo Nordisk expands API capacity

Life sciences

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.