Blog
RSS FeedPosted by Michael Wonder on 02 Mar 2017
FDA accepts new drug application and grants priority review for enasidenib in relapsed or refractory AML with an IDH2 mutation
1 March 2017 - PDUFA date set for 30 August 2017. ...
Posted by Michael Wonder on 02 Mar 2017
Dynavax announces FDA acceptance for review of its complete response to November 2016 CRL and PDUFA action date for Heplisav-B
28 February 2017 - Dynavax Technologies announced today that the U.S. FDA has accepted for review Dynavax's responses to the complete ...
Posted by Michael Wonder on 01 Mar 2017
Teva announces priority review granted by FDA for SD-809 for treatment of tardive dyskinesia
28 February 2017 - Teva Pharmaceutical Industries today announced the U.S. FDA has accepted the new drug application and granted ...
Posted by Michael Wonder on 28 Feb 2017
OncoSec granted FDA fast track designation for ImmunoPulse IL-12 for the treatment of metastatic melanoma following progression on pembrolizumab or nivolumab
28 February 2017 - Provides opportunities for upcoming Phase 2b PISCES clinical trial and future clinical development. ...
Posted by Michael Wonder on 25 Feb 2017
The importance of Swiss-style claims in Australia
24 February 2017 - The Federal Court has recently issued a decision that highlights the importance of including Swiss-style claims ...
Posted by Michael Wonder on 25 Feb 2017
Auris Medical receives FDA fast track designation for AM-111 in acute sensorineural hearing loss
24 February 2017 - Auris Medical today announced that the US FDA has granted fast track designation for AM-111 in ...
Posted by Michael Wonder on 23 Feb 2017
Novartis drug Zykadia receives FDA priority review for first-line use in patients with ALK+ metastatic NSCLC
23 February 2017 - Priority review based on Phase III study results showing 16.6 month median progression-free survival in previously untreated ...
Posted by Michael Wonder on 22 Feb 2017
Lead cancer immunotherapy candidate receives FDA fast track designation
21 February 2017 - Cell Medica today announced the U.S. FDA has granted fast rrack designation to its lead oncology ...
Posted by Michael Wonder on 22 Feb 2017
Pfizer announces acceptance of regulatory submission for inotuzumab ozogamicin by the U.S. FDA
21 February 2017 - Application requests approval for the treatment of relapsed or refractory acute lymphoblastic leukaemia in adults. ...
Posted by Michael Wonder on 21 Feb 2017
Vericel receives FDA fast track designation for ixmyelocel-T, an investigational product for the treatment of patients with advanced heart failure due to ischaemic dilated cardiomyopathy
21 February 2017 - Vericel Corporation today announced that the U.S. FDA has designated the investigation of ixmyelocel‑T for reduction ...
Posted by Michael Wonder on 21 Feb 2017
The Medicines Company announces FDA filing acceptance of new drug application for intravenous antibiotic Carbavance (meropenem-vaborbactam)
21 February 2017 - The Medicines Company today announced that the U.S. FDA has accepted for priority review the Company’s ...
Posted by Michael Wonder on 18 Feb 2017
Consultation on revised policy on access to documents
17 February 2017 - Comments from stakeholders invited until 18 May 2017. ...
Posted by Michael Wonder on 18 Feb 2017
When is applying for listing on the Pharmaceutical Benefits Scheme not an infringement?
16 February 2017 - In the most recent judgement in the Australian Lyrica litigation, Nicholas J has delivered an interesting decision ...
Posted by Michael Wonder on 16 Feb 2017
U.S. FDA accepts biologics license application for Mylan and Biocon's proposed biosimilar pegfilgrastim for review
16 February 2017 - Second successful BLA filing of the partnership in the U.S. ...
Posted by Michael Wonder on 15 Feb 2017
Axsome Therapeutics receives FDA fast track designation for AXS-05 for treatment resistant depression
14 February 2017 - Axsome Therapeutics has received fast track designation from the U.S. FDA for AXS-05 for treatment resistant depression. ...