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RSS FeedPosted by Michael Wonder on 12 Nov 2022
European Commission approves Livtencity (maribavir) for the treatment of adults with post-transplant cytomegalovirus infection and/or disease that are refractory (with or without resistance) to one or more prior therapies
11 November 2022 - Livtencity is the first and only treatment approved for this indication by the EC. ...
Posted by Michael Wonder on 11 Nov 2022
Pfizer and BioNTech receive positive CHMP opinion for Omicron BA.4/BA.5 adapted bivalent COVID-19 vaccine booster for children 5 through 11 years of age in European Union
10 November 2022 - Pfizer and BioNTech today announced a booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine (Comirnaty Original/Omicron ...
Posted by Michael Wonder on 11 Nov 2022
Meeting highlights from the 7-10 November 2022 CHMP meeting
11 November 2022 - The EMA’s CHMP recommended four medicines for approval at its November 2022 meeting. ...
Posted by Michael Wonder on 11 Nov 2022
CHMP issues opinion related to review of medicines within the Janus kinase inhibitor class
11 November 2022 - AbbVie announced today the EMA's CHMP has adopted an opinion following a nine month review of the ...
Posted by Michael Wonder on 11 Nov 2022
Dupixent (dupilumab) recommended for EU approval by the CHMP for the treatment of prurigo nodularis
11 November 2022 - Recommendation is based on data from two pivotal trials showing Dupixent significantly improved itch, skin lesions and ...
Posted by Michael Wonder on 11 Nov 2022
Sanofi and GSK’s next-generation COVID-19 booster vaccine VidPrevtyn Beta approved by the European Commission
10 November 2022 - First and only next-generation protein-based adjuvanted COVID-19 booster approved in Europe. ...
Posted by Michael Wonder on 09 Nov 2022
Study: high concordance in breakthrough therapy, PRIME decisions
8 November 2022 - The US FDA and the EMA agreed on nearly two-thirds of decisions to grant or deny ...
Posted by Michael Wonder on 04 Nov 2022
Beyfortus approved in the EU for the prevention of RSV lower respiratory tract disease in infants
4 November 2022 - European Commission grants first approval worldwide following positive CHMP opinion in September. ...
Posted by Michael Wonder on 03 Nov 2022
BeiGene receives European Commission approval for Brukinsa (zanubrutinib) for the treatment of adults with marginal zone lymphoma
2 November 2022 - Brukinsa is the first and only Bruton’s tyrosine kinase inhibitor for marginal zone lymphoma approved in the ...
Posted by Michael Wonder on 01 Nov 2022
Vaxzevria receives full marketing authorisation in the EU for the prevention of COVID-19
1 November 2022 - AstraZeneca's COVID-19 vaccine, Vaxzevria (ChAdOx1-S [Recombinant]), has been granted full marketing authorisation in the European Union. ...
Posted by Michael Wonder on 01 Nov 2022
European Medicines Agency validates Santhera’s marketing authorisation application for vamorolone in Duchenne muscular dystrophy
31 October 2022 - Santhera Pharmaceuticals announces that the EMA has validated its marketing authorisation application for vamorolone for the treatment ...
Posted by Michael Wonder on 30 Oct 2022
Pharming announces EMA validates its marketing authorisation application under accelerated assessment for leniolisib
28 October 2022 - Marketing authorisation in the European Economic Area anticipated in H1 2023 ...
Posted by Michael Wonder on 29 Oct 2022
Almirall announces EMA acceptance for filing of marketing authorisation application for lebrikizumab in atopic dermatitis
28 October 2022 - The EMA application is based on the analysis of Phase 3 studies ADvocate 1&2 and ADhere. ...
Posted by Michael Wonder on 28 Oct 2022
EMA recommends measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders
28 October 2022 - EMA’s safety committee (PRAC) has recommended measures to minimise the risk of serious side effects associated ...
Posted by Michael Wonder on 28 Oct 2022
AbbVie announces submissions of regulatory applications for epcoritamab (DuoBody-CD3xCD20) for the treatment of relapsed/refractory diffuse large B-cell lymphoma and large B-cell lymphoma
28 October 2022 - EMA validates AbbVie's marketing authorisation application; Genmab submits biologics license application to US FDA. ...