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RSS FeedPosted by Michael Wonder on 19 Jul 2016
Ipsen announces the acceptance by the European Medicines Agency of the marketing authorization application for telotristat etiprate to treat carcinoid syndrome caused by neuroendocrine tumors, in combination with somatostatin analogues
18 July 2016 - Ipsen today announced that the EMA has accepted the submission of filing for telotristat etiprate as ...
Posted by Michael Wonder on 18 Jul 2016
Samsung Bioepis’ marketing authorization application for SB5 adalimumab biosimilar candidate accepted for review by the European Medicines Agency
18 July 2016 - If approved, SB5, a biosimilar candidate referencing Humira (adalimumab), will be Samsung Bioepis’ third anti-TNF-α biosimilar ...
Posted by Michael Wonder on 18 Jul 2016
Merck receives European Medicines Agency acceptance for review of marketing authorization application for cladribine tablets
18 July 2016 - Merck today announced that the EMA has accepted for review the marketing authorisation application of the ...
Posted by Michael Wonder on 18 Jul 2016
Bristol-Myers Squibb announces regulatory updates for Opdivo (nivolumab) in previously treated recurrent or metastatic squamous cell carcinoma of the head and neck
18 July 2016 - Bristol-Myers Squibb Company announced today U.S. and European marketing applications to expand the use of Opdivo for ...
Posted by Michael Wonder on 08 Jul 2016
Rare Cancers Australia lodges PBAC submission
8 July 2016 - Rare Cancers Australia has lodged a submission for the reimbursement of MSD's Zolinza (vorinistat) for cutaneous T-cell ...
Posted 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
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
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 21 Jun 2016
Santhera’s marketing authorization application for Raxone in Duchenne muscular dystrophy validated by the European Medicines Agency
21 June 2016 - Santhera Pharmaceuticals announces that the EMA has validated its marketing authorization application for Raxone (idebenone) for ...
Posted by Michael Wonder on 21 Jun 2016
Mitsubishi Tanabe Pharma submits new drug application for edaravone to treat ALS in the United States
20 June 2016 - Mitsubishi Tanabe Pharma Corporation today announced that a new drug application has been submitted to the ...
Posted by Michael Wonder on 20 Jun 2016
Ariad initiates submission of new drug application for brigatinib to the U.S. FDA ahead of plan
17 June 2016 - Ariad Pharmaceuticals today announced the initiation of a new drug application submission for its investigational anaplastic lymphoma ...
Posted by Michael Wonder on 16 Jun 2016
Charleston Laboratories and Daiichi Sankyo announce FDA acceptance of new drug application for CL-108
13 June 2016 – Charleston Laboratories, Inc. and Daiichi Sankyo, Inc. today announced that the U.S. FDA has accepted for ...
Posted by Michael Wonder on 16 Jun 2016
EMA publishes list of applications for new human medicines under evaluation by the CHMP
16 June 2016 - This document lists information on applications for centralised marketing authorisation for human medicines that the EMA ...
Posted by Michael Wonder on 15 Jun 2016
Marathon Pharmaceuticals announces submission of deflazacort new drug application to the FDA
14 June 2016 - Deflazacort has fast track status, orphan drug designation and rare paediatric disease designation for Duchenne muscular dystrophy. ...