BioCentury | Sep 28, 2018
Clinical News

CHMP backs Luxturna, Lilly's migraine mAb, antibiotic Vabomere

...Tokyo:4151) for mycosis fungoides or Sézary syndrome. Jivi is a pegylated recombinant human Factor VIII (rFVIII...
BioCentury | Sep 21, 2018
Company News

CHMP backs Luxturna, Lilly's migraine mAb, antibiotic Vabomere

...Tokyo:4151) for mycosis fungoides or Sézary syndrome. Jivi is a pegylated recombinant human Factor VIII (rFVIII...
BioCentury | Aug 31, 2018
Clinical News

FDA approves Bayer's recombinant Factor VIII for hemophilia A

...hemophilia drugs in its class. Jivi is a pegylated recombinant form of human Factor VIII (rFVIII...
BioCentury | Nov 3, 2017
Clinical News

FDA accepts for review Bayer's BAY 94-9027 to treat hemophilia A

...early September, Bayer submitted an MAA to EMA for the pegylated recombinant human Factor VIII (rFVIII...
BioCentury | Oct 30, 2017
Company News

FDA accepts Bayer’s BLA for hemophilia A candidate

...early September, Bayer submitted an MAA to EMA for the pegylated recombinant human Factor VIII (rFVIII...
BioCentury | Sep 26, 2017
Company News

GSK, Gilead, Shire gain RDPAC membership

...an HCV NS5A protein inhibitor. Shire markets multiple drugs in China including recombinant factor VIII (rFVIII...
BioCentury | Mar 25, 2017
Strategy

Mountain climbing

...concizumab may have over emicizumab. He added that had Novo’s long-acting recombinant Factor Vlll ( rFVIII...
...the cut because it isn’t differentiated enough from other long-acting factor replacements, or from recombinant rFVIII...
...hemophilia A in 2014; additional Phase III data are expected in 2018. Three other long-acting rFVIII...
BioCentury | Feb 11, 2017
Strategy

Building Bioverativ

...about twice weekly. Three other long-acting therapies for hemophilia A have since been launched: Afstyla lonoctocog alfa...
BioCentury | Jan 13, 2017
Clinical News

Afstyla regulatory update

...The European Commission approved an MAA from CSL for Afstyla lonoctocog alfa for treatment and prophylaxis of...
...to launch Afstyla in Europe “in the coming months.” The recombinant coagulation single-chain Factor VIII (rFVIII...
...CSL Ltd. (ASX:CSL), Melbourne, Australia Product: Afstyla lonoctocog alfa ( rVIII-SingleChain , CSL627) Business: Hematology Julian Zhu Afstyla CSL627 rVIII-SingleChain CSL Ltd. lonoctocog alfa...
BioCentury | Dec 31, 2016
Finance

Delivering takeouts

BioCentury’s 25th annual Buyside View finds biotech investors focusing on mid-cap names with late-stage or marketed products that could become M&A targets. “The main theme playing at the moment is investors like us are looking...
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