To mark the publication of the 9th edition of the European Pharmacopoeia (Ph. Eur.), the EDQM (European Directorate for the Quality of Medicines) organized a large international conference in Tallinn, Estonia, which brought together representatives of European and international regulatory authorities, the World Health Organization (WHO), pharmacopoeias from different continents as well as industry and associations from Europe and beyond. Participants came from 41 different countries, including Brazil, Canada, India, Japan, South Africa, Taiwan and USA.
- INICIO
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Genéricos
Novedades
- FDA approves generic teriparatide and levetiracetam
- US generics launch and approval for Dr Reddy’s and Lupin
- Five Chinese companies join UN’s MPP for Covid-19 medicines
- South Korean companies to make generic Bridion and COVID-19 drugs
Investigación
- Saudi FDA drug approvals and GMP inspections: trend analysis
- Generic medications in the Lebanese community: understanding and public perception
- Community pharmacists’ understanding of generic and biosimilar drugs: Lebanon case study
- Reshaping landscape of Japanese generics market – uncertain future of universal health insurance
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Biosimilares
Novedades
- FDA approves third ustekinumab biosimilar Pyzchiva
- La FDA aprueba el primer biosimilar de eculizumab, Bkemv, para dos enfermedades raras
- EMA recommends approval of biosimilar bevacizumab Avzivi
- EC biosimilar approvals: Omlyclo, Jubbonti/Wyost, and Pyzchiva
Investigación
- Resultados principales del programa de desarrollo clínico del biosimilar candidato AVT05 golimumab
- Eficacia y seguridad del P043 propuesto (Zerafil) frente al omalizumab de referencia en el asma alérgica
- Tocilizumab and pembrolizumab biosimilar advances for Korean firms
- Unveiling key clinical findings for denosumab biosimilar candidates
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