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September 02, 2022
A new unitary patent system is due to come into effect in Europe later on this year.
August 23, 2022
NICE has recommended the use of Tavneos (avacopan) in combination with rituximab or cyclophosphamide regimen.
Kapruvia (difelikefalin) has been granted approval by Swissmedic as a treatment for moderate-to-severe pruritis associated with CKD.
The European Commission (EC) has approved Celltrion Healthcare's Vegzelma (CT-P16), a biosimilar to bevacizumab referencing Avastin.
EMA has accepted the marketing authorization application for an oral fixed-dose combination treatment as an initial treatment for adults with AML.
August 15, 2022
A case study discussing why post-approval changes present a very low risk, and therefore can be downgraded from a prior-approval to a notification after implementation and managed in the PQS with immediate implementation effect.
August 02, 2022
Screening for apparent total nitrosamine content with a thermal energy analyzer offers a rapid way of identifying contaminated drug products.
Pharma’s leveraging real-world evidence to drive product approval, reimbursement, and market access.
July 25, 2022
A joint statement calling for international collaboration on the creation and use of real-world evidence has been published by the International Coalition of Medicines Regulatory Authorities.
July 02, 2022
A new strategy aims to bring in legislative reforms that will impact medicinal product regulation within Europe.