Blog
RSS FeedPosted by Michael Wonder on 03 May 2018
How the U.S. compares to Europe on biosimilar approvals and products in the pipeline
2 May 2018 - FDA has not approved any biosimilar drug in 2018. ...
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 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 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 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 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 ...
Posted by Michael Wonder on 16 Nov 2017
Akcea and Ionis announce acceptance of marketing applications in US, EU and Canada for volanesorsen for the treatment of FCS
15 November 2017 - FDA Prescription Drug User Fee Act goal date set for 30 August 2018. ...
Posted by Michael Wonder on 31 Oct 2017
FDA takes unprecedented step toward more efficient global pharmaceutical manufacturing inspections
31 October 2017 - Agency completes eight capability assessments as part of the Mutual Recognition Agreement between the U.S. and European ...
Posted by Michael Wonder on 29 Aug 2017
U.S. FDA and EMA accept regulatory submissions for Bosulif (bosutinib) for the treatment of patients with newly diagnose Ph+ chronic myeloid leukaemia
29 August 2017 - Applications seek to expand approved use of Bosulif into first- line treatment based on positive results from ...
Posted by Michael Wonder on 25 Aug 2017
Vertex announces acceptance of its applications for review of the tezacaftor/ivacaftor combination treatment in people with cystic fibrosis by the FDA and EMA
24 August 2017 - FDA grants priority review of the application and sets action date of 28 February 2018. ...
Posted by Michael Wonder on 24 Aug 2017
FDA, EMA and EC sign new confidentiality commitment
24 August 2017 - The US FDA can now share non-public and commercially confidential information, including trade secrets relating to ...