UK – Grifols’ Tavlesse receives NICE recommendation
Therapy treats refractory chronic immune thrombocytopenia and is available across UK.
Grifols has announced that its treatment for adults with chronic immune thrombocytopenia (ITP), Tavlesse...
USA – Pharma industry making some headway in DSCSA implementation
The pharmaceutical industry and its trading partners are making “some progress” in implementing the necessary systems to comply with the Drug Supply Chain Security Act (DSCSA),...
USA – Comparability protocols: Final guidance incorporates ICH Q12, allows for API supplier changes
The US Food and Drug Administration’s (FDA) last week released a final guidance to assist the pharmaceutical industry in submitting comparability protocols for postapproval...
USA – FDA issues final guidance on AML drug development, two oncology draft guidances
The US Food and Drug Administration has published a final guidance and two draft guidances that detail its thinking on developing certain types of...
USA – FDA addresses alternative inspection tools, expectations for nitrosamine assessments in updated CPGs
The US Food and Drug Administration’s (FDA) has updated two compliance program guides (CPGs) covering pre-approval inspections (PAIs) and routine good manufacturing practice (GMP)...
Europe – Codéine et ibuprofène (Antarene codeine) : cas d’abus/dépendance et mise en garde...
Le comité de pharmacovigilance (PRAC) de l’Agence européenne des médicaments (EMA) recommande de nouvelles mesures pour réduire les risques d’insuffisance respiratoire et de sepsis...
USA – FDA releases discussion paper on distributed and point-of-care manufacturing
The US Food and Drug Administration (FDA) has released a discussion paper on emerging and advanced manufacturing technologies concerning the distributed manufacturing (DM) and...
Europe – New vaccine to protect people in the EU and worldwide against dengue
EMA’s human medicines committee (CHMP) has adopted a positive opinion for Dengue Tetravalent Vaccine (live, attenuated) Takeda, used to prevent disease caused by dengue...
Europe – First therapy to treat transplant patients with post-transplant lymphoproliferative disease
The European Medicines Agency (EMA) has recommended a marketing authorisation in the European Union (EU) for Ebvallo (tabelecleucel) for the treatment of adult and paediatric...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
10 new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended 10 medicines for approval at its October 2022 meeting.
The CHMP recommended granting a marketing authorisation for Dengue Tetravalent...
