BioCentury | Oct 27, 2020
Product Development

Oct. 26 Quick Takes: COVID trips up Spectrum’s Rolontis at FDA; plus Jazz-SpringWorks, Novartis’ iptacopan, Kantaro, Eternygen

...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...
BioCentury | Dec 26, 2019
Clinical News

Spectrum’s value halved after poziotinib’s failure in NSCLC cohort

...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...
BioCentury | Apr 6, 2019
Finance

Everybody up

...Pharmaceutical Co. Ltd. (KRX:128940) / Spectrum Pharmaceuticals Inc. (NASDAQ:SPPI) Spectrum withdraws a BLA for Rolontis eflapegrastim...
BioCentury | Mar 15, 2019
Company News

Another setback for Spectrum's remaining pipeline after Rolontis BLA withdrawal

...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...
BioCentury | Jan 18, 2019
Company News

Spectrum divesting marketed products to focus on late-stage programs

...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...
BioCentury | Jan 17, 2019
Company News

Spectrum divesting marketed products to focus on late-stage programs

...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...
BioCentury | Jul 6, 2018
Clinical News

Spectrum's Rolontis meets in second Phase III for chemotherapy-induced neutropenia

...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...
BioCentury | Feb 16, 2018
Clinical News

Spectrum's Rolontis meets in Phase III for chemotherapy-induced neutropenia

...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...
BioCentury | Jan 6, 2018
Finance

Burgeoning bellwethers

...Ph III data 2H18 Hanmi Pharmaceutical Co. Ltd. (KOSDAQ:128940) / Spectrum Pharmaceuticals Inc. (NASDAQ:SPPI) Rolontis eflapegrastim...
BioCentury | Sep 29, 2017
Clinical News

Spectrum completes enrollment in Phase III trial of Rolontis for chemotherapy-induced neutropenia

...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...
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