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RSS FeedPosted by Michael Wonder on 16 Mar 2017
Cardiome receives Notice of Compliance from Health Canada for its Brinavess NDS
14 March 2017 - Cardiome Pharma Corporation announced today that it received a Notice of Compliance for Brinavess (vernakalant hydrochloride, IV) ...
Posted by Michael Wonder on 16 Mar 2017
Sunovion submits supplemental new drug application to FDA for use of Aptiom (eslicarbazepine acetate) for the treatment of partial-onset seizures in children 4 years of age and older
15 March 2017 - If approved, Aptiom would provide an important new monotherapy or adjunctive therapy treatment option for individuals ...
Posted by Michael Wonder on 16 Mar 2017
GSK announces US regulatory submission seeking expanded indication for Fluarix Quadrivalent (influenza vaccine) for infants 6 months and older
15 March 2017 - GSK today announced the submission of a supplemental biologics license application to the U.S. FDA for ...
Posted by Michael Wonder on 16 Mar 2017
Nine submissions done and two due by month end…
16 March 2017 - Industry advocacy at AusBiotech is in ‘top gear’ with nine submissions completed on behalf of members ...
Posted by Michael Wonder on 15 Mar 2017
Sanofi’s dupilumab joins UK’s early access scheme
14 March 2017 - Patients with atopic dermatitis are to get early access to Sanofi’s dupilumab before its marketing authorisation ...
Posted by Michael Wonder on 15 Mar 2017
Merck provides update on supplemental biologics license application for Keytruda (pembrolizumab) in previously treated advanced microsatellite instability-high cancer
14 March 2017 - Merck today announced that the U.S. FDA has extended the action date for the supplemental biologics ...
Posted by Michael Wonder on 11 Mar 2017
Radius Health receives notification of PDUFA extension for abaloparatide
10 March 2017 - PDUFA goal date extended by standard extension period of three months to 30 June 2017. ...
Posted by Michael Wonder on 10 Mar 2017
Keryx Biopharmaceuticals announces U.S. FDA filing acceptance of supplemental new drug application for Auryxia (ferric citrate) tablets
8 March 2017 - Keryx Biopharmaceuticals today announced that the U.S. FDA has accepted for review the supplemental new drug ...
Posted by Michael Wonder on 10 Mar 2017
Nicox resubmits AC-170 (Zerviate) NDA to the U.S. FDA
9 March 2017 - CGMP issues at the API manufacturer have been resolved. ...
Posted by Michael Wonder on 09 Mar 2017
PolyPid announces receipt of qualified infectious disease product designation from FDA for D-Plex in post-cardiac surgery sternal infection
8 March 2017 - Company intends to seek regulatory approvals in U.S. and Europe in coming year to conduct Phase ...
Posted by Michael Wonder on 09 Mar 2017
PTC Therapeutics announces FDA acknowledgment of new drug application filing for Translarna for the treatment of nonsense mutation Duchenne muscular dystrophy
6 March 2017 - FDA has assigned a PDUFA date of 24 October 2017. ...
Posted by Michael Wonder on 08 Mar 2017
FDA accepts supplemental new drug application for Vraylar (cariprazine)
8 March 2017 - Application seeks to expand Vraylar label to include phase 3 clinical data for the maintenance treatment ...
Posted by Michael Wonder on 07 Mar 2017
FDA grants fast track designation for Mesoblast's cell therapy in children with acute graft versus host disease
7 March 2017 - Mesoblast today announced that the US FDA has granted a fast track designation for the use of ...
Posted by Michael Wonder on 06 Mar 2017
Merck and Pfizer announce U.S. FDA and EMA filing acceptances of three marketing applications for ertugliflozin-containing medicines for adults with type 2 diabetes
6 March 2017 - Investigational SGLT2 Inhibitor submitted as monotherapy and in fixed-dose combinations with Januvia (sitagliptin) or metformin. ...
Posted by Michael Wonder on 05 Mar 2017
Acerus files a new drug submission for Gynoflor in Canada
1 March 2017 - Acerus Pharmaceuticals today announced that it has filed a new drug submission for Gynoflor with Health Canada. ...