Blog
RSS FeedPosted by Michael Wonder on 30 Apr 2018
Access to biosimilars in EU expected to continue to outpace US and Canada
27 April 2018 - Biosimilar experts from across the EU continued to show how rapidly biosimilars have gained market share, ...
Posted by Michael Wonder on 26 Apr 2018
Incorporating the patient experience into regulatory decision making in the USA, Europe, and Canada
26 April 2018 - The clinical development of cancer therapeutics is a global undertaking, and incorporation of the patient experience into ...
Posted by Michael Wonder on 04 Apr 2018
U.S. FDA and European Medicines Agency accept regulatory submissions for review of dacomitinib to treat metastatic non-small-cell lung cancer with EGFR-activating mutations
4 April 2018 - FDA priority review granted for U.S. new drug application. ...
Posted by Michael Wonder on 27 Mar 2018
Lexicon Pharmaceuticals announces regulatory submissions for sotagliflozin to treat adults with type 1 diabetes
26 March 2018 - New drug application submitted to U.S. FDA and marketing authorisation application submitted to EMA. ...
Posted by Michael Wonder on 20 Mar 2018
U.S. FDA grants priority review for a supplemental new drug application for Xtandi (enzalutamide) in non-metastatic castration-resistant prostate cancer
19 March 2018 - Application seeks to expand the indication of Xtandi to include men with non-metastatic castration-resistant prostate cancer. ...
Posted by Michael Wonder on 02 Mar 2018
Biogen and AbbVie announce the voluntary worldwide withdrawal of marketing authorisations for Zinbryta (daclizumab) for relapsing multiple sclerosis
2 March 2018 - Patient safety is the top priority for Biogen and AbbVie. ...
Posted by Michael Wonder on 28 Feb 2018
Novo Nordisk files for regulatory approval of long-acting factor VIII (N8-GP) in the US and the EU for treatment of haemophilia A
28 February 2018 - Novo Nordisk today announced the submission of a biologics license applications to the US FDA and ...
Posted by Michael Wonder on 27 Feb 2018
Shionogi announces FDA new drug application and EMA marketing authorisation application acceptances for lusutrombopag (S-888711)
26 February 2018 - Shionogi announced today that the new drug application for lusutrombopag (S-888711), an investigational, once-daily, orally administered, ...
Posted by Michael Wonder on 27 Feb 2018
EU cancer drugs rejection shows contrasts with FDA
26 February 2018 - Europe’s expert medicines panel has rejected Puma Biotechnology’s breast cancer drug neratinib, citing limitations in its ...
Posted by Michael Wonder on 24 Feb 2018
FDA approves drugs before EMA and Swissmedic, comparison finds
23 February 2018 - From 2007 to 2016, the US FDA approved more new drugs and biologics first than its ...
Posted by Michael Wonder on 13 Feb 2018
U.S., EU and Japan health authorities accept regulatory submissions for review of Pfizer's third-generation ALK inhibitor lorlatinib
12 February 2018 - U.S. new drug application granted FDA priority review. ...
Posted 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 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 17 Nov 2017
Towards a single development programme for new antibiotics in EU, Japan and US
17 November 2017 - EMA, PMDA and FDA to further align data requirements and explore options to streamline paediatric development. ...
Posted by Michael Wonder on 17 Nov 2017
Celgene and bluebird bio announce bb2121 anti-BCMA CAR-T cell therapy has been granted breakthrough therapy designation from FDA and PRIME eligibility from EMA for relapsed and refractory multiple myeloma
16 November 2017 - Designations based on preliminary clinical data from ongoing phase I study of bb2121 in heavily pre-treated multiple ...