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

The R&D analytical solutions will consist of analytical lab services that use USP’s in-house scientific expertise and state-of-the-art facilities at the USP Advanced Manufacturing Technology Lab in Richmond and the USP headquarters facility in Rockville, Md.

Ferring Pharmaceuticals’ Rebyota was approved for the prevention of recurrence of Clostridioides difficile infection.

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

In addition, personnel, equipment, and facilities from the acquired companies will expand Reaction Biology’s presence in Germany while enabling its global customers to leverage Bioassay’s expansive portfolio of regulated clinical and commercial services.

Pharmaceutical Technology Europe got the scoop on Agilent's new Dissolution Testing Centre of Excellence in Craven Arms, UK.

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.

mRNA may not be a train we necessarily all need to get onboard immediately, but we should know where the central train station is located, and what it connects us to.

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

Results from Eisai and Biogen’s Alzheimer's treatment, lecanemab, indicated significantly slowed cognitive decline in patients relative to placebo.

Merck will use BigHat’s AI/machine learning-enabled platform to design candidates for up to three drug discovery programs.

AstraZeneca inked a deal worth up to $320 million to purchase Neogene Therapeutics, a biotech start-up focused on T-cell receptor therapies.

The agreement will see Immutep and Merck KGaA, Darmstadt, Germany jointly fund the INSIGHT-005 study.

Aptamer’s new 18,000 ft² facility will expand the company's capacity to deliver novel binders for bioprocessing, diagnostic, and drug development.

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

The decision to move forward in Phase III development stems from the threat of resistance to current malaria treatment growth.

SPX-001, a respiratory drug candidate, will be submitted through a combined Clinical Trial and Ethics Committee application for further advancement in the clinical stages.

CSL’s Hemgenix (etranacogene dezaparvovec) will cost approximately $3.5 million, making it the most expensive single-use medicine in the United States.

Merck will purchase Imago BioSciences, a biotechnology company focused on bone marrow disorders, for approximately $1.35 billion.

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.

The Pioneer Antibody Discovery Platform is a new antibody discovery service specifically designed to develop best-in-class biologic candidates.

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.