
FDA GUIDANCE ON BISPECIFIC ANTIBODY DEVELOPMENT
Bispecific antibodies (bsAbs) are genetically engineered, recombinant antibodies having two distinct binding domains capable of binding two different antigens or…
READ
Bispecific antibodies (bsAbs) are genetically engineered, recombinant antibodies having two distinct binding domains capable of binding two different antigens or…
READ
In the context of the COVID-19 pandemic, great attention is given to the sanitation measures of people and environments. People…
READ
Involvement of patients is becoming a fundamental principle throughout drug development and during regulatory advice and assessment. Patients have been…
READ
A new electronic interface for the preparation of Pricing and Reimbursement e-Dossiers has been developed by AIFA and has become available since 31st May…
READ
In Italy, with a few exceptions, the public price (VAT included) of medicines reimbursed by the NHS is subject to…
READ
The Italian Medicines Agency (AIFA) has published an update concerning the documentation for the submission of Phase I, II, III…
READ
The Italian Medicines Agency (AIFA), in line with what is reported in the Guideline on good pharmacovigilance practices (GVP) Module…
READ
Advanced therapy medicinal products (ATMPs) consist of products that contain recombinant nucleic acids or engineered cells and/or tissues representing a…
READ
May 26th, 2021 has been the official day for the entry into force of the new regulation of medical devices…
READ
The European Medicines Agency (EMA) and the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) signed a confidentiality…
READ