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RSS FeedPosted by Michael Wonder on 03 Jan 2017
2016 in review
4 January 2017 - The PBAC considered 192 submissions in 2016; 193 were considered by the Committee in 2015. ...
Posted by Michael Wonder on 03 Jan 2017
TGA rejects Fetzima
3 January 2016 - The TGA rejects the registration dossier for Pierre Fabre's serotonin noradrenaline reuptake inhibitor (SNRI). ...
Posted by Michael Wonder on 23 Dec 2016
Portola Pharmaceuticals announces FDA accepts new drug application for priority review and EMA validates marketing authorisation application for oral, factor Xa inhibitor anticoagulant betrixaban
23 December 2016 - Portola Pharmaceuticals today announced that the U.S. FDA accepted Portola's new drug application granting priority review ...
Posted by Michael Wonder on 23 Dec 2016
Novelion Therapeutics’ subsidiary files for European approval for metreleptin as a treatment for generalised lipodystrophy and a subset of patients with partial lipodystrophy
21 December 2016 - If approved, metreleptin would be the first medication available in the EU to treat generalized and ...
Posted by Michael Wonder on 21 Dec 2016
FDA accepts supplemental new drug application for Pfizer’s Ibrance (palbociclib) in HR+, HER2- metastatic breast cancer
21 December 2016 - sNDA includes data from Phase 3 PALOMA-2 trial to support conversion from accelerated approval to regular ...
Posted by Michael Wonder on 21 Dec 2016
Summary of the agenda for the PBAC March 2017 meeting
22 December 2016 - The PBAC will consider 40 submissions (23 major & 17 minor) at its next scheduled meeting ...
Posted by Michael Wonder on 21 Dec 2016
Janssen submits two applications to FDA seeking approval of Simponi Aria (golimumab) for the treatment of active psoriatic arthritis and active ankylosing spondylitis
20 December 2016 - Janssen Biotech announced today the submission of two supplemental biologics license applications to the U.S. FDA seeking ...
Posted by Michael Wonder on 21 Dec 2016
Tesaro announces priority review designation for niraparib NDA
20 December 2016 - Niraparib new drug application accepted for review by FDA with a PDUFA goal date of 30 ...
Posted by Michael Wonder on 21 Dec 2016
FDA extends review of application for Ocrevus (ocrelizumab)
20 December 2016 - Roche announced today that the U.S. FDA has extended the Prescription Drug User Fee Act date for ...
Posted by Michael Wonder on 20 Dec 2016
Sarepta Therapeutics announces EMA validation of eteplirsen authorisation application for treatment of Duchenne muscular dystrophy amenable to exon skipping 51
19 December 2016 - Sarepta Therapeutics today announced that the EMA validated the previously submitted marketing authorisation application for eteplirsen to ...
Posted by Michael Wonder on 20 Dec 2016
ProMetic initiates rolling submission of its biologics license application for plasminogen with U.S. FDA
19 December 2016 - ProMetic Life Sciences announced today that it has initiated the rolling submission of its biologics license ...
Posted by Michael Wonder on 19 Dec 2016
AbbVie submits new drug application to U.S. FDA for its investigational regimen of glecaprevir/pibrentasvir for the treatment of all major genotypes of chronic hepatitis C
19 December 2016 - AbbVie's investigational regimen was granted breakthrough therapy designation by the FDA for genotype 1 patients not ...
Posted by Michael Wonder on 18 Dec 2016
Janssen submits application seeking FDA approval of Stelara (ustekinumab) for the treatment of adolescents with moderate to severe plaque psoriasis
16 December 2016 - Janssen Biotech announced today the submission of a supplemental biologics license application to the U.S. FDA seeking ...
Posted by Michael Wonder on 12 Dec 2016
Flexion Therapeutics submits new drug application for Zilretta to treat knee osteoarthritis pain
12 December 2016 - Flexion Therapeutics today announced it has submitted a new drug application to the U.S. FDA for its ...
Posted by Michael Wonder on 11 Dec 2016
Gilead submits new drug application to U.S. FDA for the investigational single tablet regimen sofosbuvir/velpatasvir/voxilaprevir
8 December 2016 - If approved, SOF/VEL/VOX would be the first once daily single tablet regimen available as a salvage ...