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RSS FeedPosted by Michael Wonder on 14 Apr 2016
Co-operation between regulators and HTA bodies creates synergies
14 April 2016 - The EMA and the European network for Health Technology Assessment (EUnetHTA) published today a report on their ...
Posted by Michael Wonder on 13 Apr 2016
EMA publishes EPAR for Wakix
13 April 2016 - The EMA has published a European Public Assessment Report (EPAR) for Wakix (pitolisant). ...
Posted by Michael Wonder on 08 Apr 2016
Sandoz receives EC approval for subcutaneous route of administration in biosimilar Binocrit's nephrology indication
8 April 2016 - Sandoz announced today that the European Commission (EC) has approved a type II variation for the addition ...
Posted by Michael Wonder on 07 Apr 2016
CHMP issues positive opinion to include new data in European label for Xtandi (enzalutamide)
7 April 2016 - Medivation and Astellas Pharma Inc. announced today that the CHMP of the EMA has issued a positive ...
Posted by Michael Wonder on 07 Apr 2016
Giotrif (afatinib dimaleate) approved in Europe as new oral treatment option for patients with squamous cell carcinoma of the lung
7 April 2016 - Boehringer Ingelheim today announced that the European Commission has granted marketing authorisation for Giotrif (afatinib dimaleate) for ...
Posted by Michael Wonder on 07 Apr 2016
Novartis receives EU approval for Revolade as first-in-class therapy for children aged 1 year and above with chronic ITP
7 April 2016 - Novartis announced today that the European Commission (EC) has approved Revolade (eltrombopag olamine) for the treatment of ...
Posted by Michael Wonder on 06 Apr 2016
European Commission approves expanded use of Opdivo (nivolumab) to include previously treated metastatic non-squamous non-small cell lung cancer
6 April 2016 - Bristol-Myers Squibb Company announced today that the European Commission has approved Opdivo (nivolumab) monotherapy for locally advanced ...
Posted by Michael Wonder on 06 Apr 2016
European Commission approves Bristol-Myers Squibb’s Opdivo (nivolumab) for previously treated advanced renal cell carcinoma
6 April 2016 - Bristol-Myers Squibb Company announced today that the European Commission has approved Opdivo (nivolumab) monotherapy for an additional ...
Posted by Michael Wonder on 04 Apr 2016
Extrapolation of data from adults to children can facilitate development of paediatric medicines
4 April 2016 - The EMA has published a preliminary version of its draft reflection paper which outlines a framework for ...
Posted by Michael Wonder on 03 Apr 2016
Flixabi, an infliximab biosimilar candidate referencing Remicade, receives positive CHMP opinion
1 April 2016 - The CHMP has issued a positive opinion for the marketing authorization of Flixabi (infliximab). Previously known as ...
Posted by Michael Wonder on 02 Apr 2016
Bristol-Myers Squibb receives positive CHMP opinion for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for treatment of advanced melanoma
1 April 2016 - Bristol-Myers Squibb Company announced today that the CHMP has recommended the approval of Opdivo in combination with ...
Posted by Michael Wonder on 02 Apr 2016
European Medicines Agency validates Bristol-Myers Squibb’s application for Opdivo (nivolumab) for the treatment of classical Hodgkin's lymphoma patients
30 March 2016 - Bristol-Myers Squibb Company announced today that the EMA validated a type II variation application, which seeks ...
Posted by Michael Wonder on 01 Apr 2016
New gene therapy for the treatment of children with ultra-rare immune disorder recommended for approval
1 April 2016 - The EMA has recommended granting a marketing authorisation in the European Union for a new gene therapy ...
Posted by Michael Wonder on 01 Apr 2016
First oral treatment for Fabry disease recommended for approval in the EU
1 April 2016 - The EMA has recommended granting a marketing authorisation in the European Union for Galafold (migalastat hydrochloride) for ...
Posted by Michael Wonder on 01 Apr 2016
New treatment for patients with multiple myeloma
1 April 2016 - The EMA has recommended granting a conditional marketing authorisation for Darzalex (daratumumab) for the treatment of adults ...