Blog
RSS FeedPosted by Michael Wonder on 02 Nov 2016
Celltrion seeks EMA approval of Herceptin biosimilar
31 October 2016 - South Korean biopharma developer Celltrion said Monday that it has submitted its Herceptin biosimilar to the ...
Posted by Michael Wonder on 01 Nov 2016
European Medicines Agency validates the marketing authorization application for avelumab for the treatment of metastatic Merkel cell carcinoma
31October 2016 - If approved, avelumab, an investigational anti-PD-L1 IgG1, could be the first treatment indicated for patients with metastatic ...
Posted by Michael Wonder on 01 Nov 2016
Novartis LEE011 (ribociclib) granted FDA priority review for first-line treatment of HR+/HER2- advanced breast cancer
1 November 2016 - A marketing authorization application for LEE011 plus letrozole has also been accepted for review by the ...
Posted by Michael Wonder on 26 Oct 2016
Portola Pharmaceuticals submits new drug application to U.S. FDA for betrixaban for extended duration prophylaxis of venous thromboembolism in acute medically ill patients
25 October 2016 - Betrixaban, an FDA fast track-designated therapy, would be first anti-coagulant for hospital to home prevention of ...
Posted by Michael Wonder on 25 Oct 2016
EMA encourages companies to submit Type I variations for 2016 by end of November
25 October 2016 - EMA to check validity of submissions by end 2016. ...
Posted by Michael Wonder on 24 Oct 2016
GSK announces US regulatory submission of candidate vaccine for prevention of shingles
24 October 2016 - Regulatory submissions in the EU and Canada remain on track for 2016. ...
Posted by Michael Wonder on 21 Oct 2016
U.S. FDA accepts for priority review the supplemental biologics license application for Opdivo (nivolumab) in previously treated patients with advanced form of bladder cancer
21 October 2016 - Submission based on results from Phase 2 study CheckMate-275 evaluating Opdivo in patients with previously treated platinum-refractory ...
Posted by Michael Wonder on 21 Oct 2016
Teva announces FDA acceptance of resubmitted new drug application for SD-809 for treatment of chorea associated with Huntington disease
20 October 2016 - Teva Pharmaceutical Industries Ltd today announced that the U.S. FDA has accepted the resubmission of the ...
Posted by Michael Wonder on 18 Oct 2016
CADTH calls for patient input on a submission for Zinbryta (daclizumab)
18 October 2016 - CADTH is calling for patient input on Biogen's submission for Zinbryta (daclizumab). ...
Posted by Michael Wonder on 18 Oct 2016
FDA accepts for review new drug application for sodium zirconium cyclosilicate for the treatment of hyperkalaemia
18 October 2016 - AstraZeneca today announced that the US FDA has accepted a complete re-submission of a new drug ...
Posted by Michael Wonder on 12 Oct 2016
CADTH calls for patient input on submission from Servier for Corlovan
11 October - CADTH is calling for patient input on a submission from Servier for Corlovan (ivabradine hydrochloride). ...
Posted by Michael Wonder on 09 Oct 2016
Coherus Biosciences announces FDA acceptance of 351(K) biologics license application to U.S. FDA for CHS-1701 (pegfilgrastim biosimilar candidate)
6 October 2016 - Coherus BioSciences today announced that the U.S. FDA has accepted the filing of 351(k) biologics license ...
Posted by Michael Wonder on 09 Oct 2016
Guild submission to Pharmacy Review
5 October 2016 - The Pharmacy Guild of Australia has lodged its submission in response to the Review of Pharmacy ...
Posted by Michael Wonder on 07 Oct 2016
CADTH calls for patient input on a submission from Celopharma for Mifegymiso
6 October 2016 - CADTH is calling for patient input on a submission from Celopharma for its combination product Mifegymiso. ...
Posted by Michael Wonder on 04 Oct 2016
Mundipharma and Orexo announce EU regulatory submission for Zubsolv
4 October 2016 - Mundipharma and Orexo make first EU regulatory submission for Zubsolv (buprenorphine and naloxone) sublingual tablet. ...