...Pharmaceuticals Inc. (NASDAQ:SPPI) said FDA is deferring action on the company’s BLA for its Rolontis eflapegrastim...
...Fonds Technologie and other private investors.TARGETSFAAH – Fatty acid amid hydrolase BC Staff LAPS-GCSF, Rolontis, eflapegrastim (HM10460A, SPI-2012) LNP023 Spectrum...

...with the poziotinib announcement, Spectrum said FDA has accepted for review its BLA for Rolontis eflapegrastim...
...BLA after withdrawing its initial submission in March to add information about the therapy’s manufacturing. Rolontis...

...Pharmaceutical Co. Ltd. (KRX:128940) / Spectrum Pharmaceuticals Inc. (NASDAQ:SPPI) Spectrum withdraws a BLA for Rolontis eflapegrastim...

...Spectrum said Friday that it withdrew a BLA for Rolontis eflapegrastim to treat chemotherapy-induced neutropenia. Spectrum...
...late-stage compounds (see "Spectrum Divesting Marketed Products to Focus on Late-Stage Programs" ). Along with Rolontis...
...$0.30 lower to $9.98. Elizabeth S. Eaton, Staff Writer apaziquone (eoquin, EO9, Neoquin, Qapzola) LAPS-GCSF, Rolontis, eflapegrastim (HM10460A, SPI-2012) poziotinib...

...Acrotech Biopharma LLC to focus on developing and commercializing its two remaining late-stage compounds, Rolontis eflapegrastim...
...when Spectrum hopes to launch Rolontis. Last month, Spectrum submitted a BLA to FDA for Rolontis...
...Captisol-enabled Melphalan (Informal), Evomela (Other) Folotyn, pralatrexate (PDX) Fusilev, levoleucovorin (Isovorin, ISO-Vorin, levofolinic acid) LAPS-GCSF, Rolontis, eflapegrastim (HM10460A, SPI-2012) Marqibo...

...Acrotech Biopharma LLC to focus on developing and commercializing its two remaining late-stage compounds, Rolontis eflapegrastim...
...when Spectrum hopes to launch Rolontis. Last month, Spectrum submitted a BLA to FDA for Rolontis...
...Captisol-enabled Melphalan (Informal), Evomela (Other) Folotyn, pralatrexate (PDX) Fusilev, levoleucovorin (Isovorin, ISO-Vorin, levofolinic acid) LAPS-GCSF, Rolontis, eflapegrastim (HM10460A, SPI-2012) Marqibo...

...Spectrum Pharmaceuticals Inc. (NASDAQ:SPPI) said Rolontis eflapegrastim met the primary endpoint of non-inferiority to Neulasta pegfilgrastim...
...Pharmaceuticals Inc. (NASDAQ:SPPI), Henderson, Nev. Hanmi Pharmaceutical Co. Ltd. (KSE:128940), Seoul, South Korea Product: Rolontis eflapegrastim...
...cycle one Status: Phase III data Milestone: Submit BLA (4Q18) Jaime De Leon LAPS-GCSF, Rolontis, eflapegrastim (HM10460A, SPI-2012) Hanmi...

...cancer who received docetaxel and cyclophosphamide every 21 days showing that Rolontis eflapegrastim (LAPS-GCSF, HM10460A, SPI-2012...
...plans to submit a BLA to FDA in 4Q18 for Rolontis to treat chemotherapy-induced neutropenia. Rolontis...
...Henderson, Nev. Hanmi Pharmaceutical Co. Ltd. (KOSDAQ:128940), Seoul, South Korea Product: Rolontis eflapegrastim (LAPS-GCSF, HM10460A, SPI-2012...

...Ph III data 2H18 Hanmi Pharmaceutical Co. Ltd. (KOSDAQ:128940) / Spectrum Pharmaceuticals Inc. (NASDAQ:SPPI) Rolontis eflapegrastim...

...of Rolontis eflapegrastim to treat chemotherapy-induced neutropenia. The open-label, North American trial is evaluating subcutaneous Rolontis...
...count recovery, depth of absolute neutrophil count nadir and febrile neutropenia incidence in cycle 1. Rolontis...
...Pharmaceutical Co. Ltd. (KOSDAQ:128940), Seoul, South Korea Product: Rolontis eflapegrastim ( LAPS-GCSF , HM10460A , SPI-2012...