40 documents

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20:15 , Nov 9, 2018 |  BC Week In Review  |  Clinical News

FDA extends review of Samsung Bioepis' trastuzumab biosimilar

A Samsung Bioepis Co. Ltd. spokesperson told BioCentury that FDA extended by three months its review of a BLA for SB3, a biosimilar of cancer drug Herceptin trastuzumab from Roche (SIX:ROG; OTCQX:RHHBY) and its Genentech...
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01:14 , Nov 9, 2018 |  BC Extra  |  Company News

FDA extends review of Samsung Bioepis' trastuzumab biosimilar

A Samsung Bioepis Co. Ltd. spokesperson told BioCentury that FDA extended by three months its review of a BLA for SB3, a biosimilar of cancer drug Herceptin trastuzumab from Roche (SIX:ROG; OTCQX:RHHBY) and its Genentech...
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19:29 , Oct 26, 2018 |  BC Week In Review  |  Clinical News

CHMP backs Takhzyro, Dengue vaccine, biosimilar Herceptin

EMA’s CHMP on Oct. 19 recommended several approvals, including hereditary angioedema (HAE) mAb Takhzyro lanadelumab, dengue vaccine Dengvaxia and Herceptin trastuzumab biosimilar Ogivri. CHMP backed Takhzyro from Shire plc (LSE:SHP; NASDAQ:SHPG) to prevent recurrent attacks...
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23:38 , Oct 19, 2018 |  BC Extra  |  Company News

CHMP backs Takhzyro, Dengue vaccine, biosimilar Herceptin

EMA’s CHMP recommended several approvals Friday, including hereditary angioedema (HAE) mAb Takhzyro lanadelumab, dengue vaccine Dengvaxia and Herceptin trastuzumab biosimilar Ogivri. CHMP backed Takhzyro from Shire plc (LSE:SHP; NASDAQ:SHPG) to prevent recurrent attacks of HAE....
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18:23 , Jun 8, 2018 |  BC Week In Review  |  Clinical News

FDA rebuffs third biosimilar Herceptin

Amgen Inc. (NASDAQ:AMGN) received a complete response letter from FDA for ABP 980. This marks the third CRL the agency has issued for a biosimilar of Herceptin trastuzumab. Amgen declined to disclose details of the...
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20:53 , Jun 1, 2018 |  BC Extra  |  Company News

FDA rebuffs third biosimilar Herceptin

Amgen Inc. (NASDAQ:AMGN) said Friday it received a complete response letter from FDA for ABP 980. This marks the third CRL the agency has issued for a biosimilar of Herceptin trastuzumab. Amgen declined to disclose...
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19:31 , Apr 27, 2018 |  BC Week In Review  |  Clinical News

Pfizer receives CRL for Herceptin biosimilar

Pfizer Inc. (NYSE:PFE) received a complete response letter from FDA for a BLA for PF-05280014, the company’s biosimilar of Herceptin trastuzumab. Pfizer said FDA requested additional technical information unrelated to safety or clinical data, but...
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16:45 , Apr 23, 2018 |  BC Extra  |  Company News

Pfizer receives CRL for Herceptin biosimilar

Pfizer Inc. (NYSE:PFE) received a complete response letter from FDA for a BLA for PF-05280014, the company’s biosimilar of Herceptin trastuzumab. Pfizer said FDA requested additional technical information unrelated to safety or clinical data, but...
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17:09 , Apr 6, 2018 |  BC Week In Review  |  Clinical News

FDA issues CRLs for Celltrion biosimilars

Celltrion Inc. (KOSDAQ:068270) received complete response letters from FDA for BLAs for Herzuma biosimilar trastuzumab (CT-P6) and Truxima biosimilar rituximab (CT-P10). Celltrion told BioCentury the letters are directly related to FDA's January warning letter describing...
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23:21 , Apr 5, 2018 |  BC Extra  |  Company News

FDA issues CRLs for Celltrion biosimilars

Celltrion Inc. (KOSDAQ:068270) received complete response letters from FDA for BLAs for Herzuma biosimilar trastuzumab (CT-P6) and Truxima biosimilar rituximab (CT-P10). Celltrion told BioCentury the letters are directly related to FDA's January warning letter describing...
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