Blog
RSS FeedPosted by Michael Wonder on 14 Jun 2018
Building synergy between regulatory and HTA agencies beyond processes and procedures—can we effectively align the evidentiary requirements? A survey of stakeholder perceptions
13 June 2018 - The pathway for bringing a new medicine to the market is dependent on two sequential processes: achieving ...
Posted by Michael Wonder on 12 Jun 2018
Themis receives EMA PRIME designation for Chikungunya vaccine
11 June 2018 -Themis announced today that the EMA has granted PRIority MEdicines (PRIME) designation to its most advanced program ...
Posted by Michael Wonder on 11 Jun 2018
European Commission approves Prolia (denosumab) for patients with glucocorticoid-induced osteoporosis
8 June 2018 - Third Indication in Europe for Prolia for the treatment of patients at increased risk of fractures. ...
Posted by Michael Wonder on 11 Jun 2018
The EU approves Tagrisso for first-line treatment of EGFR-mutated non-small cell lung cancer
8 June 2018 - First-line Tagrisso offers a potential new standard of care. ...
Posted by Michael Wonder on 07 Jun 2018
Public hearing on quinolones and fluoroquinolones: 23 speakers from 11 EU countries to share experience
7 June 2018 - Agenda and list of speakers for 13 June hearing available ...
Posted by Michael Wonder on 07 Jun 2018
U.S. FDA and EMA accept regulatory submissions for review of tazaloparib for metastatic breast cancer patients with an inherited BRCA mutation
7 June 2018 - U.S. new drug application granted FDA priority review. ...
Posted by Michael Wonder on 06 Jun 2018
Nohla receives EMA PRIME designation for dilanubicel (NLA101) to treat haematopoietic stem cell transplant patients
6 June 2018 - First product to achieve PRIME designation for haematopoietic stem cell transplant patients. ...
Posted by Michael Wonder on 06 Jun 2018
Audentes announces PRIME designation granted by the EMA to AT132 for the treatment of X-linked myotubular myopathy
5 June 2018 - Audentes Therapeutics today announced that the EMA has granted PRIME designation to AT132 for the treatment ...
Posted by Michael Wonder on 05 Jun 2018
Mabion completes marketing authorisation application for flagship drug, MabionCD20, to the EMA
5 June 2018 - • Mabion is first Polish biotech company to successfully complete development of a biosimilar drug independently and to ...
Posted by Michael Wonder on 05 Jun 2018
Lupin submits marketing authorisation application for etanercept biosimilar in Europe
23 May 2018 - Pharma major Lupin announced today that its marketing authorization application for a biosimilar of etanercept has been ...
Posted by Michael Wonder on 04 Jun 2018
Europe's drug agency warns of bigger staff losses in Brexit move
1 June 2018 - Regulator says it underestimated challenges of relocation. ...
Posted by Michael Wonder on 04 Jun 2018
Clovis Oncology submits application to EMA to expand use of Rubraca (rucaparib) to include maintenance treatment for women with recurrent ovarian cancer
4 June 2018 - Submission based on positive phase 3 ARIEL3 clinical trial in which rucaparib significantly improved PFS in all ...
Posted by Michael Wonder on 04 Jun 2018
Two more EU Member States benefit from EU-US mutual recognition agreement for inspections
1 June 2018 - Agreement now operational between 14 EU Member States and FDA. ...
Posted by Michael Wonder on 02 Jun 2018
Akcea and Ionis receive positive EU CHMP opinion for Tegsedi
1 June 2018 - Akcea Therapeutics and Ionis Pharmaceuticals announced today that the CHMP of the EMA has adopted a positive ...
Posted by Michael Wonder on 02 Jun 2018
Lundbeck and Otsuka's Rxulti (brexpiprazole) receives positive opinion in EU from CHMP for the treatment of schizophrenia in adults
1 June 2018 - A final decision from the European Commission is expected within 67 days. ...