Blog
RSS FeedPosted by Michael Wonder on 11 Sep 2016
CADTH calls for patient input on submission from Duchesnay for Mictoryl (propiverine hydrochloride)
9 February 2016 - CADTH is seeking patient input on a submission from Duchesnay for Mictoryl. ...
Posted by Michael Wonder on 07 Sep 2016
FDA accepts supplemental biologics license application, assigns priority review and grants breakthrough therapy designation to Merck’s Keytruda (pembrolizumab) for first-line treatment of patients with advanced non-small-cell lung cancer
7 September 2016 - Merck has also submitted a marketing authorization application to the EMA for Keytruda in the same patient ...
Posted by Michael Wonder on 01 Sep 2016
FDA accepts Mitsubishi Tanabe Pharma’s NDA filing for edaravone to treat ALS
30 August 2016 - Edaravone may be the first ALS treatment approved in U.S. in more than 20 years. ...
Posted by Michael Wonder on 01 Sep 2016
ARIAD completes rolling submission of new drug application for brigatinib to the U.S. FDA
30 August 2016 - ARIAD Pharmaceuticals today announced it has completed the rolling submission of the new drug application for its ...
Posted by Michael Wonder on 31 Aug 2016
Neurocrine submits new drug application for valbenazine for treatment of tardive dyskinesia
29 August 2016 - Neurocrine Biosciences today announced that it has submitted a new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 30 Aug 2016
FDA accepts CSL Behring’s BLA for first subcutaneous prophylactic therapy to prevent hereditary angioedema attacks
30 August 2016 - CSL today announced that the US FDA has accepted for review CSL Behring’s biologics license application for ...
Posted by Michael Wonder on 25 Aug 2016
Mylan and Biocon announce regulatory submission for proposed biosimilar trastuzumab accepted for review by European Medicines Agency
25 August 2016 - Mylan and Biocon announced today that the EMA has accepted for review Mylan's marketing authorization application ...
Posted by Michael Wonder on 25 Aug 2016
Submissions to the review of pharmacy remuneration and regulation
25 August 2016 - Public submissions to the review have been made public. ...
Posted by Michael Wonder on 24 Aug 2016
Summary of the agenda for the PBAC November 2016 meeting
24 August 2016 - The PBAC will consider 66 submissions (34 major & 32 minor) at its next scheduled meeting in ...
Posted by Michael Wonder on 23 Aug 2016
FDA accepts Clovis Oncology's new drug application for rucaparib for priority review for the treatment of advanced mutant BRCA ovarian cancer
23 August 2016 - Seeking approval for mutant BRCA patients treated with two or more prior therapies. ...
Posted by Michael Wonder on 22 Aug 2016
Sanofi provides update on new drug application for investigational once-daily fixed-ratio combination of insulin glargine and lixisenatide
19 August 2016 - Sanofi announced today that it has submitted updated information on the pen delivery device as part ...
Posted by Michael Wonder on 19 Aug 2016
Post-market review of biological disease modifying anti-rheumatic drugs to treat severe chronic plaque psoriasis and of pulmonary arterial hypertension medicines
19 August 2016 - The public consultation process on the draft terms of reference for the two post-market reviews has closed. ...
Posted by Michael Wonder on 18 Aug 2016
PHARMAC seeking community views on changes to funding application process
18 August 2016 - PHARMAC’s decisions affect nearly all New Zealanders, and the Government pharmaceutical funding agency is asking people to ...
Posted by Michael Wonder on 17 Aug 2016
Genmab announces submission of supplemental biologics license application to FDA for daratumumab in relapsed multiple myeloma
17 August 2016 - sBLA submitted to U.S. FDA for daratumumab for treatment of patients with relapsed multiple myeloma. ...
Posted by Michael Wonder on 12 Aug 2016
CADTH calls for patient input on submission from Janssen for Stelara (ustekinumab)
12 August 2016 - CADTH has received notice of a pending submission from Janssen for ustekinumab for use by patients with ...