Industry News

Exagamglogene autotemcel seen as synechdoche.

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

The largest biotech hub is set to be built in Lithuania by Northway Group.

UK industry body, ABPI, has responded positively to the recent Autumn Statement.

Andy Geall, co-founder and chief development officer at Replicate Bioscience continues the discussion on the development history of mRNA therapeutics.

Recommended medicines include treatments for generalized myasthenia gravis, glioma, neovascular age-related macular degeneration, and more.

Andy Geall, co-founder and chief development officer at Replicate Bioscience, discusses the historical context and buildup of the mRNA therapeutics field.

Electronic product information for selected human medicines that have been harmonized across the European Union have been published for the first time.

The document includes recommendations for the reporting and implementation of changes to container closure system components.

The Alliance for mRNA Medicines (AMM) was officially launched at the 11th International mRNA Health Conference in Berlin, Germany.

The EC is calling for interested parties for their safety and orphan drug committees.

According to USP, the products will advance quality and reduce risk in the development and manufacture of biologics and vaccines.

The guidance describes the agency’s procedures for performing remote interactive evaluations at drug manufacturing and bioresearch monitoring facilities.

A recent AAPS Salary Survey shows a rising trend in compensation for pharmaceutical scientists since 2022.

CPHI Barcelona has strong showing as bio/pharma industry moves confidently into 2024.

As CMOs continue to invest in cell culture capacity, some are expected to surpass top in-house companies.

The winners of the 2023 CPHI Pharma Awards were announced on October 25 at the CPHI Barcelona event.

The agency’s solidarity mechanism allows Member States to support each other when there is a shortage of a critical medicines.

The report indicates a rise in biotech funding and subsequent growth for pharma contract services.

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

The agency recommended conditional marketing authorization for Elrexfio (elranatamab) as a monotherapy for adult patients with relapsed and refractory multiple myeloma.

The recommended medicines include treatments for Duchenne muscular dystrophy, relapsed or refractory multiple myeloma, hyperargininemia, invasive candidiasis, menopause symptoms, and diagnostic medicines for characterizing lesions.

The new Digital Health Advisory Committee will advise the agency on issues related to technologies such as AI, virtual reality, and machine learning.

The program will improve access to adeno-associated virus gene therapy vectors.

Orakl Oncology has raised funds to develop its precision oncology platform and accelerate drug development.

The commission’s membership will help facilitate reach and impact for standards harmonization.

Laks Pernenkil, principal and practice leader, US Life Sciences Product & Supply Operations, Deloitte, discusses the impact that digitalization is having on data generation and data integrity in bio/pharma manufacturing.