News dal mondo
The EU and APIs: New Rules of the Game in Manufacturing
Innovator and generic-drug companies are squaring off on a proposal by the European Commission for an export manufacturing waiver for supplementary protection certificates in the European Union. What are the implications for pharmaceutical companies and manufacturers of active pharmaceutical ingredients (APIs)?...[DCAT]
ICH Q3C(R7) Guideline and Q3C Support Documents available
The ICH Q3C(R7) Guideline, which is the result of an error correction of the Permitted Daily Exposure (PDE) for ethyleneglycol in the ICH Q3C(R6)...
Advent International acquisisce Zentiva da Sanofi
Novità rilevanti nel comparto generici: dopo quasi dieci anni all'interno del gruppo Sanofi, Zentiva passa di mano, acquisita dal fondo di private...
EU Generics Group Takes Issue With US Interference on SPC Manufacturing Waivers
Medicines for Europe, which represents the EU's generic and biosimilar medicines industry, raised concerns earlier this month with discussions...
ESIP - EU insurers seeking stockpiling on SPCs
The European Social Insurance Platform (ESIP) calls on EU legislators to ensure that patients’ access to high quality and affordable healthcare...