Vaccine Development and Manufacturing

The Commercial Message mRNA Products Send

February 01, 2023

This new pioneering phase of mRNA is loaded with potential, but also obstacles and false dawns.

FDA Seeks to Simplify COVID-19 Vaccination Program

January 30, 2023

FDA plans to authorize a common bivalent shot that targets both the original COVID-19 strain and Omicron subvariants.

Finding Solutions to Manage mRNA Instability

January 11, 2023

Messenger RNA is inherently unstable and thus requires unique solutions to protect its cohesion.

EMA Executive Director Sends Message of Promoting Stronger Public Presence for Safety, Efficacy of Medicines

December 22, 2022

She also mentioned the Clinical Trials Regulation and the Clinical Trials Information System (CTIS) launching at the same time to help energize the clinical research area of the EU.

EMA Recommends Five Medicines for Approval

December 22, 2022

In terms of extensions, the committee recommended Adcirca, Dupixent, Edistride, Enhertu, Fintepla, Forxiga, Hemlibra, Imfinzi (including two new indications), Kerendia, Spikevax and Triumeq.

European Commission Approves Spevigo for Generalized Psoriasis Flares

December 13, 2022

The approval is based on results from the pivotal EFFISAYIL 1 Phase II clinical trial.

Moderna Receives FDA Emergency Use Authorization for Omicron-Targeting Bivalent COVID-19 Booster Vaccine in Children

December 13, 2022

mRNA-1273.222 has also received FDA EUA for children and adolescents between six and 17 years of age and for adults over the age of 18 years of age.

Steriline Showcases Filling Equipment at CPHI 2022

November 02, 2022

Steriline will be exhibiting its vial filling and capping machine (VFCM100) under double-wall isolator for aseptic filling at CPHI 2022 in Frankfurt, Germany, on Nov. 1–3, 2022.

Process Development and Control for New Modalities

November 02, 2022

Increasing molecular diversity is creating a need for the reinvention of process development and control strategies.

EMA Recommends Adapted Spikevax Vaccine

October 21, 2022

The agency has recommended authorization of the Spikevax COVID-19 vaccine that targets the Omicron variants BA.4 and BA.5.