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May 11, 2023
EC has granted marketing authorization to Chiesi Global Rare Diseases and Protalix BioTherapeutics for PRX-102 (pegunigalsidase alfa).
May 10, 2023
EMA and European regulators are lifting their COVID-19 business continuity measures as the pandemic’s peak ends.
May 02, 2023
Guidance for GMP manufacture of emerging therapies has evolved to accommodate innovation and the broader spectrum of products in development, but greater harmonization is still needed.
April 02, 2023
Proposed regulatory changes signal a major overhaul of legislation governing pharmaceuticals and healthcare in Spain.
March 15, 2023
The impact of the potential ban would have serious consequences for the availability of many drugs for European patients.
March 02, 2023
Stepwise paediatric investigation plans aim to boost the development of medicines for children.
February 03, 2023
Harmonization of global regulations fosters innovation and ensures quality medicines.
February 02, 2023
The European bio/pharma industry’s high regulatory standards and GMP requirements are set to position the region as a frontrunner for pharmaceutical‑grade manufacturing of cannabis-based medicines.
A new unified initiative for patent protection in the EU to boost the competitiveness of the pharma industry is nearing completion.
January 03, 2023
Bio/pharma has evolved and adapted to a variety of challenges in 2022, but what might be on the cards for the industry in 2023?