Blog
RSS FeedPosted by Michael Wonder on 29 Jun 2016
Sandoz Canada regulatory submission for subsequent entry biologic etanercept accepted for review by Health Canada
28 June 2016 - Sandoz Canada announced today that Health Canada has accepted for review its regulatory submission for a ...
Posted by Michael Wonder on 29 Jun 2016
Prescription medicines: pre-submission pilot
29 June 2016 - The TGA is introducing pilot changes to the pre-submission phase of the prescription medicines registration process. ...
Posted by Michael Wonder on 28 Jun 2016
FDA approves Epclusa for treatment of chronic Hepatitis C virus infection
28 June 2016 - The U.S. FDA approved Epclusa to treat adult patients with chronic hepatitis C virus (HCV) both with ...
Posted by Michael Wonder on 28 Jun 2016
TGA publishes AusPAR for Proshaeos (alprostadil)
28 June 2016 - The TGA has published an AusPAR for Montrose Pharma's Proshaeos (alprostadil). ...
Posted by Michael Wonder on 28 Jun 2016
Roche’s marketing applications for review of Ocrevus (ocrelizumab) in two forms of multiple sclerosis accepted by EMA and FDA
28 June 2016 - Ocrevus is the first investigational medicine seeking marketing authorisation for both relapsing and primary progressive multiple sclerosis. ...
Posted by Michael Wonder on 27 Jun 2016
The role of single-arm trials in the authorisation of new cancer medicines (update)
27 June 2016 - Joint EMA/ESMO workshop to be broadcast live on 30 June 2016. ...
Posted by Michael Wonder on 27 Jun 2016
Health Canada approves first treatment for schizophrenia dosed four times a year
27 June 2016 - 93% of patients treated with Invega Trinza remained relapse-free at the end of long-term relapse prevention trial. ...
Posted by Michael Wonder on 27 Jun 2016
Bristol-Myers Squibb’s Opdivo (nivolumab) receives breakthrough therapy designation from U.S. FDA for advanced form of bladder cancer
27 June 2016 - This milestone marks the sixth breakthrough therapy designation for Opdivo. ...
Posted by Michael Wonder on 27 Jun 2016
BioMarin withdraws submission for Kyndrisa
27 June 2016 - On 31 May 2016, BioMarin officially notified the CHMP that it wishes to withdraw its application for ...
Posted by Michael Wonder on 26 Jun 2016
Brexit spells upheaval for EU and UK drug regulation
24 June 2016 - Britain's vote to leave the European Union spells regulatory uncertainty for drug companies, with the London-based EMA, ...
Posted by Michael Wonder on 26 Jun 2016
Teva receives CHMP positive opinion for Cinqaero (reslizumab)
24 June 2016 - Add-on therapy targeting IL-5 in adults with severe eosinophilic asthma pending marketing authorization in Europe. ...
Posted by Michael Wonder on 24 Jun 2016
Highlights from the CHMP 20-23 June 2016 meeting
24 June 2016 - Six new medicines, including one cell-based therapy, recommended for approval. ...
Posted by Michael Wonder on 24 Jun 2016
Allergan announces FDA approval of supplemental new drug application for Avycaz (ceftazidime and avibactam)
23 June 2016 - Label now includes Phase 3 clinical data evaluating the safety and efficacy of Avycaz (in combination with ...
Posted by Michael Wonder on 24 Jun 2016
Health Canada issues a Notice of Compliance for Simponi as the first and only treatment indicated for non-radiographic axial spondyloarthritis
23 June 2016 - Research shows Simponi improves symptoms and physical function. ...
Posted by Michael Wonder on 23 Jun 2016
EMA publishes monthly statistics
23 June 2016 - The EMA has published a monthly statistics report on the medicinal products for human use that ...