Blog
RSS FeedPosted by Michael Wonder on 21 Nov 2022
New Quality Innovation Expert Group supports medicine innovation
21 November 2022 - The EMA has established a Quality Innovation Expert Group to support innovative approaches for the development, ...
Posted by Michael Wonder on 19 Nov 2022
BeiGene receives European Commission approval for Brukinsa (zanubrutinib) for the treatment of adults with chronic lymphocytic leukaemia
17 November 2022 - Brukinsa is the only Bruton’s tyrosine kinase inhibitor to achieve superiority over ibrutinib in relapsed/refractory chronic lymphocytic ...
Posted by Michael Wonder on 19 Nov 2022
European Commission approves Enjaymo (sutimlimab) for treatment of haemolytic anaemia in adult patients with cold agglutinin disease
17 November 2022 - Enjaymo is the first and only approved therapeutic option approved for haemolytic anaemia in adult patients ...
Posted by Michael Wonder on 15 Nov 2022
Lynparza in combination with abiraterone recommended for approval in the EU by CHMP as first-line treatment for patients with metastatic castration-resistant prostate cancer
14 November 2022 - First PARP inhibitor to demonstrate clinical benefit in combination with a new hormonal agent in this ...
Posted by Michael Wonder on 15 Nov 2022
Junshi Biosciences announces submission of a marketing authorisation application to the European Medicines Agency for toripalimab
14 November 2022 - The MAA was submitted in the EU for toripalimab seeking indications for the first-line treatment of NPC ...
Posted by Michael Wonder on 15 Nov 2022
Enhertu recommended for approval in the EU by CHMP for patients with previously treated HER2 positive advanced gastric cancer
14 November 2022 - Based on DESTINY-Gastric02, which showed Daiichi Sankyo and AstraZeneca’s Enhertu demonstrated clinically meaningful efficacy and DESTINY-Gastric01, which ...
Posted by Michael Wonder on 15 Nov 2022
Imfinzi plus chemotherapy recommended for approval in the EU by CHMP as first immunotherapy regimen for advanced biliary tract cancer
14 November 2022 - Positive opinion based on TOPAZ-1 Phase 3 trial updated survival results showing Imfinzi combination reduced risk ...
Posted by Michael Wonder on 14 Nov 2022
UCB announces US FDA acceptance of new drug application and EMA MAA validation for zilucoplan for the treatment of generalized myasthenia gravis in adult patients
14 November 2022 - New drug application for zilucoplan seeks approval for the treatment of generalised myasthenia gravis in adult patients ...
Posted 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 ...