Quality Systems

Articles

The safety profile of erdafitinib observed in THOR was consistent with the previously reported safety profile of erdafitinib in metastatic urothelial carcinoma (mUC).

Janssen Submits Marketing Authorization Application to EMA For Approval of Erdafitinib

Further expansions of the pharmaceutical development and manufacturing services of ten23 are happening at the BASE and VIVA facilities to continue to support complex sterile product development, testing, and manufacturing. 

ten23 Expands Sterile Manufacturing Capacity at VIVA 1 Facility 

Bianca Piachaud-Moustakis is lead writer at Pharmavision, Pharmavision.co.uk.

The ACT EU initiative aims to develop the European Union further as a competitive centre for innovative clinical research.

Accelerating Clinical Trials in the EU

The updated vaccine will be ready to ship following a positive European Commission review. 

Pfizer and BioNTech Get Positive Opinion in Europe for Omicron XBB.1.5-adapted COVID-19 Vaccine

The patent grants Alterity 20 years of exclusivity over a new class of iron chaperone drug candidates. 

Alterity Therapeutics Given European Composition of Matter Patent for Neurodegenerative Diseases

The assessment aims to determine whether valproate use in men could lead to neurodevelopmental disorders in their children.  

EMA Reviews Data on Paternal Exposure to Valproate

The indication for Pombiliti is a long-term enzyme replacement therapy (ERT) used in combination with miglustat for adults with late-onset Pompe disease (LOPD).

Amicus Therapeutics Launches Pompe Disease Therapy in United Kingdom

Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Current good manufacturing practices for oral solid dosage forms protect the product from contamination and potential errors.

Ensuring OSD Quality and Safety

Cheryl Barton is director of PharmaVision, 

What impact will EMA’s decision to phase out COVID-19 regulatory flexibilities have on the pharma industry?

Phasing Out COVID-19 Regulatory Flexibilities

The framework is now expanded beyond COVID-19 vaccines and treatments.

Regulatory/GMP Compliance, Europe