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RSS FeedPosted by Michael Wonder on 19 Jul 2016
Agenda for July 2016 CHMP meeting
19 July 2016 - The agenda for the 18-21 July 2016 CHMP meeting is now available. ...
Posted by Michael Wonder on 19 Jul 2016
FDA knocks back Novartis copy of Amgen's drug Neulasta
19 July 2016 - U.S. regulators have declined to approve Novartis' so-called biosimilar copy of Amgen's Neulasta drug that fights infections ...
Posted 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 19 Jul 2016
U.S. FDA approves Prezista (darunavir) for use in pregnant women with HIV
18 July 2016 - Data show Prezista is a safe and effective treatment option in pregnant women, with no reports of ...
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 18 Jul 2016
FDA accepts Scenesse clinical data package for NDA submission
18 July 2016 - Clinuvel prepares new drug application for the treatment of erythropoietic protoporphyria. ...
Posted by Michael Wonder on 18 Jul 2016
TGA cost recovery implementation statement 2016-17
18 July 2016 - This Cost Recovery Implementation Statement provides information on how the TGA implements cost recovery activities associated with ...
Posted by Michael Wonder on 18 Jul 2016
Loxo Oncology receives breakthrough therapy designation from U.S. Food and Drug Administration for LOXO-101
13 July 2016 - Loxo Oncology today announced that the U.S. FDA has granted breakthrough therapy designation to LOXO-101, a selective ...
Posted by Michael Wonder on 18 Jul 2016
FDA issues complete response letter for SequestOx new drug application
15 July 2016 - Elite Pharmaceuticals today announced that the U.S. FDA has issued a complete response letter (the regarding the ...
Posted by Michael Wonder on 16 Jul 2016
Makers of Humira and Enbrel using new drug patents to delay generic versions
15 July 2016 - The best-selling drugs Humira and Enbrel have a lot in common. ...
Posted by Michael Wonder on 15 Jul 2016
Gilead receives approval in Canada for Epclusa (sofosbuvir/velpatasvir), the first once-daily pan-genotypic (genotypes 1-6) single tablet regimen for the treatment of chronic hepatitis C
14 July 2016 - Two week treatment with Epclusa provides high cure rates for all six hepatitis C genotypes. ...
Posted by Michael Wonder on 14 Jul 2016
Gormley’s take: road to launching ‘biosimilar’ drugs just got longer
13 July 2016 - Small companies developing lower-cost copies of expensive biotechnology drugs already faced a tough road launching their products. ...
Posted by Michael Wonder on 13 Jul 2016
Amgen biosimilar gets thumbs up from FDA panel
13 July 2016 - ABP 501 designed to be a lower-cost alternative to AbbVie’s blockbuster Humira. ...