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A paper has stated that applying the quality by design (QbD) principle during development of bilayer tablets will “help improve product design while also enhancing the quality, safety, and efficacy of drug products”.
If approved, the treatment could provide the first oral, at-home, neuroactive steroid therapy to treat postpartum depression (PPD).
Former Senior Vice President, Head of Research and Product Development of Alexion, will succeed Mene Pangalos as Executive Vice President, BioPharmaceuticals R&D at AstraZeneca.
Extended EU approval of Soliris to paediatric generalised myasthenia gravis (gMG) patients is based on Phase III data which demonstrated improvement in disease severity through 26 weeks.
Topline data from a Phase II trial signify a significant step forward for ENHERTU® (trastuzumab deruxtecan) in its potential to provide a new option in HER2 expressing cancers.
EPIQ is a single platform for Quality, Document, and Learning Management. It offers integration across departments for a seamless quality management.
The planned €50 million investment at the Finland-based CDMO facility will enable advanced technologies to be used for development and manufacture of advanced therapy medicinal products (ATMPs).
The first SGLT2 inhibitor to demonstrate a statistically significant reduction in all-cause hospitalisations in chronic kidney disease (CKD) patients versus placebo has been approved in the EU.
Key data from a Phase II trial of a potentially first-in-class CSF-1R monoclonal antibody for chronic graft-versus-host disease (GVHD) has been released.
Key opportunities within the small molecule active pharmaceutical ingredient (API) market include adopting continuous manufacturing and delving into niche disease areas, research has indicated.
The European Medicines Agency (EMA) has updated its guidance on nitrosamine impurities in human medicinal products, amending Q&A 10 and adding three appendices.
A paper has highlighted a drug product quality assurance programme for personalised preparations, including application of a preventive or corrective measures (CAPA) system.
If approved by the European Commission (EC), ORSERDU® (elacestrant) would be the first treatment for ER+, HER2- advanced or metastatic breast cancer tumours with ESR1 mutations.
An RNAi therapeutic that has best-in-disease potential for hypertension is set to be developed under a partnership between Roche and Alnylam Pharmaceuticals.
A planned investment of approximately $90 million will help build Sandoz’s new Slovenia-based biopharma biosimilar development facility by 2026.
