Blog
RSS FeedPosted by Michael Wonder on 25 Apr 2017
EMA publishes withdrawal assessment report for Zioxtenzo
25 April 2017 - On 18 January 2017, Sandoz officially notified the CHMP that it wishes to withdraw its application ...
Posted by Michael Wonder on 20 Apr 2017
Full Federal Court confirms an application to list medicine on the PBS prior to patent expiry is a non-infringing act
19 April 2017 - Late last week, the Full Federal Court of Australia confirmed that the mere act of filing a ...
Posted by Michael Wonder on 19 Apr 2017
Egalet announces U.S. FDA acceptance of file for prior approval supplement for Oxaydo (oxycodone hydrochloride) tablets 10 mg and 15 mg dosage strengths
18 April 2017 - FDA goal date is 17 June 2017. ...
Posted by Michael Wonder on 19 Apr 2017
PHARMAC reject request to fund women's hygiene products
19 April 2017 - The government's drug-buying agency has rejected a request to fund women's hygiene products. ...
Posted by Michael Wonder on 17 Apr 2017
AMAG submits supplemental new drug application to FDA for Makena (hydroxyprogesterone caproate injection) auto-injector for subcutaneous use
17 April 2017 - FDA decision anticipated on supplemental new drug application filing in the fourth quarter 2017. ...
Posted by Michael Wonder on 14 Apr 2017
Relmada announces FDA fast track designation for d-methadone for adjunctive treatment of major depressive disorder
13 April 2017 - Relmada Therapeutics today announced that the U.S. FDA has granted fast track designation for d-Methadone (REL-1017, dextromethadone), ...
Posted by Michael Wonder on 07 Apr 2017
Innocrin Pharmaceuticals granted fast track designation by FDA for seviteronel treatment of women with triple-negative breast cancer and women or men with estrogen receptor-positive breast cancer
6 April 2017 - Innocrin has announced that the FDA granted a second fast track designation for seviteronel (VT-464). ...
Posted by Michael Wonder on 06 Apr 2017
Prometic completes the filing of its plasminogen biologics license application with the U.S. FDA
5 April 2017 - Prometic Life Sciences announced today that it has completed the filing of its plasminogen biologics license ...
Posted by Michael Wonder on 04 Apr 2017
U.S. FDA accepts for priority review Bristol-Myers Squibb’s application for Opdivo (nivolumab) in previously treated dMMR or MSI-H metastatic colorectal cancer
4 April 2017 - Application based on results from Phase 2 CheckMate-142 study. ...
Posted by Michael Wonder on 04 Apr 2017
AbbVie announces Ibrutinib (Imbruvica) supplemental new drug application for previously treated chronic graft-versus-host-disease accepted for review by U.S. FDA
4 April 2017 - AbbVie today announced a supplemental new drug application was accepted for review by the U.S. FDA for ...
Posted by Michael Wonder on 04 Apr 2017
Jazz Pharmaceuticals completes rolling submission of new drug application for Vyxeos (CPX-351), an investigational treatment for acute myeloid leukaemia
3 April 2017 - Jazz Pharmaceuticals today announced the completion on 31 March 2017 of a rolling submission of a new ...
Posted by Michael Wonder on 02 Apr 2017
Kite completes submission of U.S. biologics license application for axicabtagene ciloleucel as the first CAR-T therapy for the treatment of patients with aggressive non-Hodgkin lymphoma
31 March 2017 - Kite is preparing for potential approval and launch for axicabtagene ciloleucel in 2017. ...
Posted by Michael Wonder on 31 Mar 2017
Novo Nordisk resubmits new drug application for fast-acting insulin aspart in the US
29 March 2017 - Novo Nordisk today announced that the company has resubmitted the new drug application for fast-acting insulin ...
Posted by Michael Wonder on 30 Mar 2017
U.S. FDA approves addition of moderate to severe fingernail psoriasis data to AbbVie's Humira (adalimumab) prescribing information
30 March 2017 - Phase 3 data demonstrate improvement in moderate to severe fingernail psoriasis. ...
Posted by Michael Wonder on 30 Mar 2017
FDA grants priority review for Amgen's Blincyto (blinatumomab) supplemental biologics license application
29 March 2017 - Application includes overall survival data from phase 3 TOWER study to support conversion from accelerated approval to ...