Vaccine Development and Manufacturing

Pfizer’s bivalent RSV prefusion F vaccine has been approved by FDA to prevent lower respiratory tract disease resulting from the respiratory syncytial virus in adults 18 to 59 years of age who are at increased risk.

Evonik's plant-based squalene, PhytoSquene, used in parenteral drug delivery applications, won the CPHI Excellence in Pharma Award in the “Sustainability” category.

There is potential to effectively marry the best aspects of mRNA as a modality, to other existing or nascent exciting platforms, such as gene editing.

The agency is recommending the extension of the smallpox and mpox vaccine, Imvanex, to adolescents aged 12 to 17.

A coordinated and international response is needed to help control the latest mpox outbreak in Africa.

The approvals and authorizations come amid a late summer surge in the virus that is tracking a bit earlier than the early fall wave in the US in 2023.

National Institutes of Health’s National Institute of Allergy and Infectious Diseases collaborated with the University of Sciences, Techniques and Technologies of Bamako, Mali to conduct the trials.

The virus, which is contagious and a common cause of respiratory illness, hospitalizes up to 160,000 people and is responsible for as many as 13,000 deaths in the United States every year.

The companies have restructured their existing collaboration into a licensing agreement that invests in mRNA development.

The companies have completed the expansion and qualification phase and now enter a stand-by phase for five years.

An ASGCT Panel titled Novel Nucleic Acid and Cell-based Vaccines for Cancer highlights promising mRNA personalized cancer vaccine work.

This research focuses on refining the clarification step by assessing the performance of various depth filters. The study explores both conventional cellulose-based and innovative synthetic depth filters, utilizing pneumococcal fermentation harvests from two challenging serotypes.

The outcomes of a workshop organized by WHO and ICMRA regarding COVID-19 vaccine strain updates are presented in a report published by regulators.

The collaboration will focus on differentiated cancer vaccine candidates in hematological and solid tumor indications to treat unmet medical needs.

A tidal wave of questions floats the need for more upstream automation.

AstraZeneca has completed its acquisition of Icosavax, gaining the IVX-A12 vaccine candidate that targets RSV and hMPV.

Regulators from around the world will gather to help shape the mRNA and RNA therapeutics landscape at an exceptional April 2024 Washington, D.C. convocation.

Looking at the role that RSV and pediatric medical practices play in drug shortages.

The new centralized hub will provide advanced testing of nucleic acids, which is expected to simplify mRNA substance testing.

Industry investments indicate increasing trust in the newest modalities, including mRNA approaches.

The final guidance document was issued to assist bio/pharma companies in the clinical development and licensure of COVID-19 vaccines.

The companies will co-promote GSK’s shingles vaccine, Shingrix, to healthcare professionals and points of vaccination in China.

The prize was awarded jointly to Katalin Karikó and Drew Weissman for their groundbreaking discovery regarding modification of the bases in mRNA.

Pfizer has entered into a collaboration with Ginkgo Bioworks to discover novel RNA molecules across priority research areas.

The companies plan on targeting the production of abundant, low-cost messenger RNA from C1-cells.

Despite its success, clinical and logistical roadblocks to mRNA cancer vaccine development remain.

mRNA may be a modality whose chief advances are yet to come.

EMA looks to focus on mRNA vaccines because their classification depends on the target and/or whether they are obtained chemically or biologically.

The acquisition will continue to strengthen the area of conjugate vaccines and bioconjugate drugs and will expand Biosynth’s capabilities from good manufacturing practice facilities located in Berlin, Germany.

The new excipients manufacturing facility is expected to be completed in 2025.