Blog
RSS FeedPosted by Michael Wonder on 22 Jun 2022
Trastuzumab deruxtecan type II variation application validated by EMA for patients with HER2 low metastatic breast cancer with HR positive and HR negative disease
22 June 2022 - Application based on DESTINY-Breast04 results that showed Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan demonstrated superior progression-free and ...
Posted by Michael Wonder on 20 Jun 2022
EMA publishes agenda for 20-23 June 2022 CHMP meeting
20 June 2022 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 17 Jun 2022
Sandoz application for proposed biosimilar adalimumab’s high concentration formulation accepted by EMA
17 June 2022 - Submission supported by comprehensive analytical and clinical data from new Phase I bridging pharmacokinetics study. ...
Posted by Michael Wonder on 11 Jun 2022
FDA approves new oncology drugs quicker than EMA
10 June 2022 - The US FDA is quicker to approve new oncology drugs compared with the EMA, according to ...
Posted by Michael Wonder on 09 Jun 2022
Bydureon BCise (exenatide prolonged-release) approved in the EU for paediatric patients with type 2 diabetes
8 June 2022 - First once weekly GLP-1 treatment option for paediatric patients with type-2 diabetes in the EU. ...
Posted by Michael Wonder on 08 Jun 2022
European Commission approves Roche’s first-in-class bispecific antibody Lunsumio for people with relapsed or refractory follicular lymphoma
8 June 2022 - Approval is based on the phase I/II GO29781 study, where Lunsumio induced high complete response rates, with ...
Posted by Michael Wonder on 08 Jun 2022
Vertex announces inaxaplin (VX-147) granted breakthrough therapy designation by U.S. FDA and PRIME designation by the EMA
8 June 2022 - Vertex granted nine breakthrough therapy designations and three PRIME designations across its pipeline programs to date. ...
Posted by Michael Wonder on 07 Jun 2022
Sifi announces EMA validation of its marketing authorisation application for Akantior for the treatment of acanthamoeba keratitis
7 June 2022 - Sifi has launched an early access program across European countries in June 2022. ...
Posted by Michael Wonder on 26 May 2022
European Commission approves Keytruda (pembrolizumab) plus chemotherapy as neo-adjuvant treatment, then continued as adjuvant monotherapy after surgery for locally advanced or early stage triple negative breast cancer at high risk of recurrence
24 May 2022 - Approval based on event-free survival benefit demonstrated in Phase 3 KEYNOTE-522 trial. ...
Posted by Michael Wonder on 26 May 2022
Roche’s Polivy combination approved by European Commission for people with previously untreated diffuse large B-cell lymphoma
25 May 2022 - Approval is based on pivotal data from the Phase 3 POLARIX study, where Polivy plus R-CHP significantly ...
Posted by Michael Wonder on 24 May 2022
EMA guidance supports development of new antibiotics
24 May 2022 - As part of its efforts to support a global approach to the development of new antimicrobial medicines, ...
Posted by Michael Wonder on 23 May 2022
'EMA's refusal to authorise Herceptin biosimilar unfair'
23 May 2022 - Prestige BioPharma's recent failure to get European approval for its Herceptin biosimilar could have resulted from ...
Posted by Michael Wonder on 23 May 2022
CHMP recommends European Commission approval of upadacitinib (Rinvoq) for the treatment of adults with moderate to severe ulcerative colitis
23 May 2022 - CHMP positive opinion is based on results from three Phase 3 studies: two for induction and one ...
Posted by Michael Wonder on 21 May 2022
CHMP recommends approval of Xenpozyme (olipudase alfa), the first and only treatment for ASMD
20 May 2022 - Recommendation based on positive results from two clinical trials in which Xenpozyme provided improvement across multiple non-CNS ...
Posted by Michael Wonder on 21 May 2022
Karyopharm and Menarini Group receive positive CHMP opinion for Nexpovio (selinexor) for the treatment of patients with refractory multiple myeloma
20 May 2022 - European Commission decision anticipated within approximately 60 days. ...