Industry News

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

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.

The guidance discusses statistical approaches for BE comparisons and focuses on how to use these approaches both generally and in specific situations.

The partnership will see the pharma giants partner with researchers from A*STAR and various Singapore universities.

The European Human Medicines Directive and Regulation is due to be updated by the end of 2022, but what changes are on the cards?

Anti-obesity drugs have the potential to be the next blockbusters, according to market analysis.

Catalent has completed the expansion of its clinical supply facility located in Shanghai, China.

Etihad Cargo is one of the only airlines to hold IATA CEIV Pharma certification globally.

The agreement aims to develop integrated technology for large-scale exosome production.

NMPA has approved Ferinject in China for the treatment of iron deficiency or iron deficiency anemia.

The complete online database of ACS Reagent Chemicals is now available.

The $286 million investment ability is designed to elevate MillioporeSigma’s ability to conduct biosafety testing and analytical development services.

The collaboration will see the companies develop investigational next-generation bispecific immunotherapies for cancer.

Rousselot Biomedical will supply Gelomics with its gelatin methacryloyl, a photo cross-linkable extracellular matrix, for use in Gelomics’ LunaGel 3D Tissue Culture System.

Tzield (teplizumab-mzwv) injection is the first FDA-approved therapy designed to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older.

Biotech startup, Cradle, has raised $5.4 million in seed funding with an AI-enabled design platform that allows for the synthetic building of cell factories to produce proteins.

Element has opened a new 7500-ft3 facility that will be used to evaluate aerosolized product efficacy for reducing airborne organisms and viral particles.

CellVax Therapeutics has selected Theragent, a new CDMO, to manufacture clinical trial material for a new Phase II prostate cancer immunotherapy drug candidate.

The new facility will allow ReiThera to consolidate its competitive position as a leading CDMO specialized in viral vector production.

Avantor is continuing its investment to support the biopharma market with the opening of its new distribution center in Dublin, Ireland.

Salipro Biotech has entered into a collaboration and license agreement with Sanofi to advance discovery programs.

The new Massachusetts facility will strengthen Cytiva’s cell culture services.

The results of the mid-term election may reduce Congress’ ability to pass FDA-related legislation during its lame duck session.

The UK MHRA has expanded the use of Cosentyx for use in pediatric arthritic conditions.

MGI and Imperial College will jointly operate a CEC designed to provide European customers with first-hand experience with various automation and sequencing instruments.

Industry and the government must work closely to ensure the UK remains a competitor in the clinical research field.

Johnson & Johnson’s acquisition of Abiomed, a provider of heart pump technologies, is designed to bolster their position in the medical technology sector.

FDA keeps its user fees but fails to gain important reforms.

The winners of the 2022 CPHI Excellence in Pharma Awards were announced on Nov. 1, 2022 at an awards ceremony in Frankfurt, Germany.

Metrics from the CPHI Annual Survey suggest that confidence in the global pharma market has risen significantly in the past year.