Blog
RSS FeedPosted by Michael Wonder on 18 Sep 2018
EMA publishes agenda for CHMP 17-20 September meeting
17 September 2018 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 18 Sep 2018
EMA validates Bristol-Myers Squibb’s application for Empliciti (elotuzumab) plus pomalidomide and low dose dexamethasone in patients with multiple myeloma
18 September 2018 - Bristol-Myers Squibb today announced that the EMA has validated the Company’s type II variation application for ...
Posted by Michael Wonder on 17 Sep 2018
EMA validates marketing authorisation application for Trogarzo
14 September 2018 - Theratechnologies is pleased to announce that the EMA has confirmed the validity of the marketing authorization ...
Posted by Michael Wonder on 15 Sep 2018
Compliance with requirement to report results on the EU Clinical Trials Register: cohort study and web resource
12 September 2018 - Following the 2012 EC guideline, sponsors must ensure that all trials registered on EUCTR since 2004 disclose ...
Posted by Michael Wonder on 14 Sep 2018
ViiV Healthcare submits regulatory application to EMA for single-tablet, two-drug regimen of dolutegravir and lamivudine for treatment of HIV
14 September 2018 - ViiV Healthcare today announced submission of a marketing authorisation application to the EMA for a single-tablet, ...
Posted by Michael Wonder on 14 Sep 2018
EMA Priority Medicines scheme (PRIME): will more paying-for-performance agreements be needed due to immature data?
14 September 2018 - The EU’s centralized procedure for the authorization of a new drug is performed by the EMA. ...
Posted by Michael Wonder on 13 Sep 2018
Improving understanding of biosimilars in the EU
13 September 2018 - New information material made available in several European languages. ...
Posted by Michael Wonder on 12 Sep 2018
Shire granted EU marketing authorization for Veyvondi [vonicog alfa, recombinant von Willebrand factor] for adults with von Willebrand disease
12 September 2018 - Marketing authorisation will enable patient access to Veyvondi throughout Europe. ...
Posted by Michael Wonder on 10 Sep 2018
European Commission approves Merck’s Keytruda (pembrolizumab) in combination with pemetrexed and platinum chemotherapy for the first-line treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumour aberrations
10 September 2018 - European approval based on results from pivotal Phase 3 trial KEYNOTE-189 demonstrating Keytruda in combination with pemetrexed ...
Posted by Michael Wonder on 10 Sep 2018
European Commission expands labelling for Janssen’s Invokana and Vokanamet to include positive data on cardiovascular outcomes
7 September 2018 - Invokana (canagliflozin) and Vokanamet (canagliflozin and metformin) labelling now approved to include positive cardiovascular outcomes from ...
Posted by Michael Wonder on 05 Sep 2018
European Commission grants marketing authorisation for Puma Biotechnology’s Nerlynx (neratinib) for extended adjuvant treatment of hormone receptor positive HER2 positive early stage breast cancer
4 September 2018 - Neratinib becomes the first anti-HER2 treatment to be EC-approved as extended adjuvant therapy for early stage hormone ...
Posted by Michael Wonder on 03 Sep 2018
Cablivi (caplacizumab) approved in Europe for adults with acquired thrombotic thrombocytopenic purpura
3 September 2018 - In addition, U.S. FDA to conduct priority review of caplacizumab with a target action date of ...
Posted by Michael Wonder on 03 Sep 2018
Britain loses medicines contracts as EU body anticipates Brexit
3 September 2018 - European Medicines Agency ends pharma evaluations work and moves contracts to bloc. ...
Posted by Michael Wonder on 03 Sep 2018
Genmab announces European marketing authorisation for Darzalex (daratumumab) for front line multiple myeloma
31 August 2018 - Darzalex approved in Europe in combination with bortezomib, melphalan and prednisone in patients with newly diagnosed multiple ...
Posted by Michael Wonder on 31 Aug 2018
Alnylam receives approval of Onpattro (patisiran) in Europe
30 August 2018 - First ever RNAi therapeutic approved in the European Union. ...