Blog
RSS FeedPosted by Michael Wonder on 31 Mar 2016
Early dialogue with regulators and HTA bodies
31 March 2016 - Parallel scientific advice at EMA helps to reconcile different data requirements in one development plan to improve ...
Posted by Michael Wonder on 24 Mar 2016
Pfizer announces European Medicines Agency accepted for review its marketing authorisation application for Xeljanz (tofacitinib citrate) for the treatment of moderate to severe rheumatoid arthritis
23 March 2016 - Pfizer announced today that the European Medicines Agency (EMA) has accepted for review the marketing authorisation application ...
Posted by Michael Wonder on 11 Mar 2016
EMA reviews cancer medicine Zydelig
11 March 2016 - The EMA has, at the request of the European Commission, started a review of the cancer medicine ...
Posted by Michael Wonder on 09 Mar 2016
European scheme to develop drugs for diseases with no treatment launched
8 March 2016 - Unlike the UK’s Early Access to Medicines scheme, PRIME does not shorten the authorisation procedure. ...
Posted by Michael Wonder on 07 Mar 2016
Launch of PRIME – Paving the way for promising medicines for patients
7 March 2016 - Today, the EMA launched its new PRIME (PRIority MEdicines) scheme to strengthen support to medicines that target ...
Posted by Michael Wonder on 03 Mar 2016
Baxalta submits marketing authorization application to the European Medicines Agency for Adynovi for treatment of haemophilia A patients
3 March 2016 - Currently marketed in the U.S. as Adynovate [Antihemophilic Factor (Recombinant), PEGylated], Adynovi is an innovative recombinant Factor ...
Posted by Michael Wonder on 03 Mar 2016
Guidance for the publication of clinical data
3 March 2016 - The EMA has published detailed guidance for pharmaceutical companies on the requirements to comply with its policy ...
Posted by Michael Wonder on 01 Mar 2016
EUSA Pharma and AVEO announce submission of marketing authorization application for tivozanib in advanced renal cell carcinoma
1 March 2016 - EUSA Pharma and AVEO Oncology today announced the submission of a marketing authorization application to the EMA ...
Posted by Michael Wonder on 27 Feb 2016
Highlights from the CHMP meeting - 22-25 February 2016
26 February 2016 - The European Medicines Agency’s CHMP recommended six new medicines for marketing authorisation at its February 2016 meeting. ...
Posted by Michael Wonder on 26 Feb 2016
Lilly receives positive CHMP opinion for ixekizumab for the treatment of moderate-to-severe plaque psoriasis
26 February 2016 - Ixekizumab is designed to specifically target IL-17A, a protein that plays a key role in driving underlying ...
Posted by Michael Wonder on 26 Feb 2016
Servier receives positive CHMP opinion for Lonsulf (trifluridine/tipiracil) for refractory metastatic colorectal cancer
26 February 2016 - Servier today announced that the CHMP of the EMA has adopted a positive opinion, recommending Lonsulf (trifluridine/tipiracil) ...
Posted by Michael Wonder on 26 Feb 2016
European CHMP adopts positive opinion for Gilead’s fixed-dose combination Descovy (emtricitabine/tenofovir alafenamide) for the treatment of HIV
26 February 2016 - Gilead Sciences, Inc. today announced that the CHMP, the scientific committee of the EMA, has adopted a ...
Posted by Michael Wonder on 26 Feb 2016
Sobi and Biogen receive positive opinion from CHMP for Alprolix (rFIXFc) for the treatment of haemophilia B
26 February 2016 - Alprolix would be among the first therapies in the EU to offer people living with hemophilia B ...
Posted by Michael Wonder on 26 Feb 2016
EMA validates Gilead’s marketing application for tenofovir alafenamide fumarate (TAF) for the treatment of chronic hepatitis B
25 February 2016 - Gilead Sciences today announced that the company’s marketing authorization application for tenofovir alafenamide fumarate (TAF) 25 mg ...
Posted by Michael Wonder on 09 Feb 2016
EMA bolsters measures to help protect patients from falsified medicines
9 February 2016 - The EMA and the European Commission have prepared an implementation plan for centrally authorised medicines to guide ...