Lupin secures external funding for its etanercept biosimilars program.
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By Bioblast Editor | Sep 13, 2017
Lupin secures external funding for its etanercept biosimilars program.
By Bioblast Editor | Sep 12, 2017
FDA accepts Sandoz’s s351(k) application for rituximab.
By Bioblast Editor | Sep 11, 2017
FDA accepts Adello Biologic’s BLA for biosimilar filgrastim.
By Bioblast Editor | Sep 09, 2017
Pfizer announces positive findings in pivotal Phase III study for TmAb candidate PF-05280014 at ESMO 17.
By Bioblast Editor | Sep 09, 2017
Amgen/Allergan present Phase III data on biosimilar trastuzumab ABP 980 at ESMO 2017.
By Bioblast Editor | Sep 07, 2017
PTAB denies institution of Coherus Biosciences’ 4 IPR petitions against AbbVie’s 9,085,619 relating to the Humira® formulation.
By Bioblast Editor | Sep 06, 2017
FDA releases Form 483 raising 12 issues arising from the May/June inspections of the Celltrion Incheon biologics manufacturing facility, where Celltrion and Pfizer/Hospira’s biosimilar Inflectra® (infliximab-dyyb) is made.
By Naomi Pearce | Sep 04, 2017
In a case relating to patents for global blockbuster biologic Humira™ (Adalimumab), the Full Federal Court has drawn a bright line around the limitations of the PTE regime in Austra...
By Bioblast Editor | Sep 02, 2017
FDA extends its decision deadline by 3 months on a s351(k) application for MYL-1401O, Mylan and Biocon’s trastuzumab (Herceptin) biosimilar. Final decision is now expected by 3 Dec 2017.
By Bioblast Editor | Aug 30, 2017
Samsung Bioepis has filed three petitions seeking joinder with Hospira’s IPR against key Genentech trastuzumab patents (IPR2017-01958 against 6,627,196 patent; IPR2017-01959 against 7,371,379, and IPR2017-01960 against 7,892,549). Hospira’s petitions against the same pat...
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