Blog
RSS FeedPosted by Michael Wonder on 14 Jun 2020
EMA management board backs rolling review fees, COVID-19 transparency measures
12 June 2020 - After its June meeting on Thursday, the EMA’s management board said it has approved a new ...
Posted by Michael Wonder on 11 Jun 2020
LEO Pharma announces European Medicines Agency acceptance of marketing authorisation application for tralokinumab for the treatment of adults with moderate-to-severe atopic dermatitis
11 June 2020 - LEO Pharma today announced that the European Medicines Agency validated the marketing authorization application for tralokinumab, an ...
Posted by Michael Wonder on 10 Jun 2020
EU expands reach of Vertex' CF drug Kalydeco
10 June 2020 - EU regulators have expanded the treatment scope of Vertex' Kalydeco (ivacaftor) to include a new subset ...
Posted by Michael Wonder on 09 Jun 2020
Europe wants to make its own drugs, but it needs American blood plasma
8 June 2020 - Europe wants to be master of its own destiny in producing essential drugs and finding COVID-19 ...
Posted by Michael Wonder on 09 Jun 2020
Mylan and Lupin receive European marketing authorisation for Nepexto, biosimilar etanercept
4 June 2020 - Mylan and Lupin today announced that the European Commission (EC) has granted marketing authorization for Nepexto, ...
Posted by Michael Wonder on 09 Jun 2020
First adjuvanted quadrivalent influenza vaccine by Seqirus receives EU approval
8 June 2020 - The European Commission has today given regulatory approval for the first adjuvanted quadrivalent influenza vaccine to become ...
Posted by Michael Wonder on 08 Jun 2020
NICE publishes appraisal consultation for isatuximab in combination with pomalidomide and dexamethasone for treating patients with relapsed and refractory multiple myeloma
4 June 2020 - The appraisal committee has considered the evidence submitted by the company and the views of non-company consultees ...
Posted by Michael Wonder on 08 Jun 2020
EU actions to support availability of medicines during COVID-19 pandemic – update #7
8 June 2020 - The EU Executive Steering Group on Shortages of Medicines Caused by Major Events held a virtual ...
Posted by Michael Wonder on 08 Jun 2020
EMA receives application for conditional authorisation of first COVID-19 treatment in the EU
8 June 2020 - EMA has now received an application for conditional marketing authorisation of the antiviral medicine remdesivir for ...
Posted by Michael Wonder on 07 Jun 2020
Bayer submits vericiguat for marketing authorization in the EU and Japan for the treatment of chronic heart failure
5 June 2020 - Regulatory submissions based on positive data from Phase III VICTORIA study recently published in the New England ...
Posted by Michael Wonder on 07 Jun 2020
Lilly bags expanded EU approval for Taltz
5 June 2020 - The European Medicines Agency has expanded the reach of Lilly's Taltz (ixekizumab) to include the treatment ...
Posted by Michael Wonder on 05 Jun 2020
Genmab announces European marketing authorisation for the subcutaneous formulation of Darzalex (daratumumab) for the treatment of patients with multiple myeloma
4 June 2020 - Approval based on data from Phase III COLUMBA and Phase II PLEIADES studies. ...
Posted by Michael Wonder on 04 Jun 2020
Patients’ and health care professionals’ organisations updated on EMA’s response to COVID-19
4 June 2020 - EMA updated patients’ and healthcare professionals’ organisations about its COVID-19 activities. ...
Posted by Michael Wonder on 04 Jun 2020
Pierre Fabre receives European approval for Braftovi (encorafenib) in combination with cetuximab for the treatment of adult patients with BRAF V600E-mutant metastatic colorectal cancer
3 June 2020 - European approval is based on the Phase 3 BEACON CRC trial that demonstrated a significant improvement in ...
Posted by Michael Wonder on 03 Jun 2020
EMA weighs COVID-19 data transparency, not ready to resume full clinical data publication
1 June 2020 - In a response to officials at Germany’s IQWiG and the Cochrane Collaboration, EMA Executive Director Guido ...