Blog
RSS FeedPosted by Michael Wonder on 12 Nov 2018
Once-daily Trelegy Ellipta gains expanded COPD indication in Europe
9 November 2018 - First single inhaler triple therapy to be specifically indicated for COPD patients not adequately treated with dual ...
Posted by Michael Wonder on 10 Nov 2018
Jazz Pharmaceuticals submits marketing authorisation application to EMA for solriamfetol as a treatment to improve wakefulness and reduce excessive daytime sleepiness in adult patients with narcolepsy or obstructive sleep apnoea
9 November 2018 - Jazz Pharmaceuticals today announced the submission of a marketing authorisation application to the EMA for solriamfetol, a ...
Posted by Michael Wonder on 07 Nov 2018
AbbVie announces Humira (adalimumab) global patent license with Momenta
6 November 2018 - AbbVie announced today patent license agreements with Momenta over its proposed biosimilar adalimumab product. ...
Posted by Michael Wonder on 06 Nov 2018
Sankyo’s FLT3 inhibitor quizartinib for treatment of patients with relapsed/refractory FLT3-ITD AML
5 November 2018 - Application based on results of pivotal phase 3 QuANTUM-R study of quizartinib in patients with relapsed/refractory FLT3-ITD ...
Posted by Michael Wonder on 04 Nov 2018
Are rumours of AbbVie's Humira price cuts what they seem?
2 November 2018 - In an effort to combat competition from biosimilar adalimumab products in Europe as patents covering the ...
Posted by Michael Wonder on 01 Nov 2018
AbbVie offers a ‘huge’ discount on Humira to fend off European rivals
1 November 2018 - In hopes of fending off biosimilar competition for its franchise drug, AbbVie has apparently won the ...
Posted by Michael Wonder on 01 Nov 2018
Vertex announces European authorisation for third cystic fibrosis medicine Symkevi (tezacaftor/ivacaftor), to be used in combination with ivacaftor (Kalydeco), for people with CF aged 12 and older with certain mutations in the CFTR gene
1 November 2018 - First medicine in the EU to treat the CFTR protein defect in patients who have one copy ...
Posted by Michael Wonder on 01 Nov 2018
AbbVie receives European Commission approval of Venclyxto (venetoclax) plus rituximab for the treatment of patients with chronic lymphocytic leukaemia who have received at least one prior therapy
1 November 2018 - The approval is based on the MURANO Phase 3 clinical trial, in which Venclyxto plus rituximab reduced ...
Posted by Michael Wonder on 31 Oct 2018
Working with stakeholders to improve availability of medicines in the EU
31 October 2018 - The task force set up by EMA and the Heads of Medicines Agencies on availability of ...
Posted by Michael Wonder on 30 Oct 2018
Astellas receives European approval for Xtandi (enzalutamide) for adult men with high-risk non-metastatic castration-resistant prostate cancer
29 October 2018 - Results from the PROSPER trial show a median metastasis-free survival of 36.6 months for enzalutamide plus androgen ...
Posted by Michael Wonder on 28 Oct 2018
Novartis receives approval for Cosentyx label update in Europe to include dosing flexibility in psoriatic arthritis
26 October 2018 - New Cosentyx (secukinumab) label to include dosing flexibility up to 300 mg, based on clinical response, and ...
Posted by Michael Wonder on 26 Oct 2018
Does fast-track drugs approval in EU run too fast?
25 October 2018 - In 2017, only 7 out of 92 medicines received a recommendation for marketing authorisation following an EU ...
Posted by Michael Wonder on 25 Oct 2018
Fast-track flu vaccine raises hopes for quicker drugs approvals
24 October 2018 - Post-Brexit registrations could be ‘five months faster’, says medicines regulator. ...
Posted by Michael Wonder on 22 Oct 2018
Vertex receives European CHMP positive opinion for Kalydeco (ivacaftor) to treat patients with cystic fibrosis aged 12 to <24 months with certain mutations in the CFTR gene
19 October 2018 - If approved, ivacaftor will be the first and only medicine to treat the underlying cause of cystic ...
Posted by Michael Wonder on 22 Oct 2018
Mylan and Biocon announce positive CHMP opinion for Ogivri, biosimilar trastuzumab
19 October 2018 - Mylan and Biocon today announced that the EMA's CHMP has issued a positive opinion recommending approval ...