Blog
RSS FeedPosted by Michael Wonder on 17 Jan 2018
Novartis granted US FDA priority review for Kymriah (tisagenlecleucel), formerly CTL019, for adults with r/r DLBCL
17 January 2018 - Filing acceptance marks second priority review granted to Kymriah by the FDA for two distinct indications, underscoring ...
Posted by Michael Wonder on 17 Jan 2018
UK drugs regulator plays down Brexit disruption threat
17 January 2018 - Britain’s drugs regulator said on Tuesday it would work to minimise disruption caused by the country leaving ...
Posted by Michael Wonder on 16 Jan 2018
Shire granted EU marketing authorisation for Adynovi [anti-haemophilic factor (recombinant), PEGylated] for adults and adolescents with haemophilia A
15 January 2018 - Marketing authorisation will enable patient access to Adynovi throughout Europe. ...
Posted by Michael Wonder on 15 Jan 2018
Italy fights back against EU: Milan's bid to scupper EMA move to Amsterdam
15 January 2018 - Italy has launched a desperate last-minute bid to scupper the move of a key agency to Amsterdam ...
Posted by Michael Wonder on 13 Jan 2018
Roche’s Ocrevus (ocrelizumab) approved in the European Union for relapsing forms of multiple sclerosis and primary progressive multiple sclerosis
12 January 2018 - First and only approved disease-modifying medicine for people in the European Union with early primary progressive multiple ...
Posted by Michael Wonder on 11 Jan 2018
AstraZeneca receives EU approval of Fasenra for severe eosinophilic asthma
10 January 2018 - Fasenra is the first-ever approved respiratory biologic medicine with an 8-week maintenance dosing schedule. ...
Posted by Michael Wonder on 10 Jan 2018
Vertex receives expanded EU approval for Orkambi (lumacaftor/ivacaftor) in children ages 6-11 years
10 January 2018 - Existing reimbursement agreements in countries like Ireland will enable rapid access to Orkambi; country-by-country reimbursement processes will ...
Posted by Michael Wonder on 10 Jan 2018
Cimzia (certolizumab pegol) label change marks important advance for European women of childbearing age with chronic rheumatic disease
8 January 2018 - Data submitted to regulatory authorities included first-of-their-kind clinical studies demonstrating minimal transfer of Cimzia through the ...
Posted by Michael Wonder on 08 Jan 2018
European Medicines Agency accepts filing for Evenity (romosozumab)
8 January 2018 - Application supported by Phase 3 data in more than 11,000 post-menopausal women and men with osteoporosis at ...
Posted by Michael Wonder on 08 Jan 2018
Brexit fears are diverting millions of pounds from vital cancer battle, say drug firms
7 January 2018 - Brexit could see pharmaceutical firms having to contend with more regulations. ...
Posted by Michael Wonder on 08 Jan 2018
UK in push to remain part of EU medicines agency
7 January 2018 - Call to stick with regulator after Brexit follows chemical and aviation sectors. ...
Posted by Michael Wonder on 05 Jan 2018
Avacopan conditional marketing authorisation application accepted for regulatory review by EMA
4 January 2018 - Conditional marketing authorisation application for treatment of patients with ANCA-associated vasculitis validated for start of procedure by ...
Posted by Michael Wonder on 30 Dec 2017
GW Pharmaceuticals submits marketing authorisation application in Europe for Epidiolex (cannabidiol) in the treatment of Lennox-Gastaut syndrome and Dravet syndrome
29 December 2017 - GW Pharmaceuticals today announced it has submitted its marketing authorisation application to the EMA for Epidiolex (cannabidiol) ...
Posted by Michael Wonder on 21 Dec 2017
European Commission approves Roche’s Alecensa (alectinib) as first-line treatment in ALK-positive lung cancer
21 December 2017 - Approval based on phase III ALEX data showing Alecensa reduced the risk of disease progression or death ...
Posted by Michael Wonder on 19 Dec 2017
Fresenius submits first biosimilar marketing authorisation application
18 December 2017 - Fresenius Kabi has submitted a marketing authorisation application to the EMA for its adalimumab biosimilar candidate of ...