18:14 , Feb 15, 2019 |  BC Week In Review  |  Company News

Samsung Bioepis partners with AffaMed, expands biosimilar development in China

Samsung Bioepis Co. Ltd. (Incheon, South Korea) partnered to develop four of its biosimilars with AffaMed Therapeutics (Shanghai, China). The partners will initially collaborate on clinical development, regulatory registration and commercialization Ontruzant, SB11, SB12 and...
01:13 , Jan 25, 2019 |  BC Week In Review  |  Clinical News

FDA delays approval of Immunomedics' ADC for triple-negative breast cancer

Immunomedics Inc. (NASDAQ:IMMU) said FDA issued a complete response letter for its BLA for sacituzumab govitecan (IMMU-132) to treat metastatic triple-negative breast cancer in a third-line setting. The company was seeking accelerated approval of the...
00:38 , Jan 25, 2019 |  BC Week In Review  |  Clinical News

Samsung's Herceptin biosimilar gains U.S. approval

FDA approved a BLA for Ontruzant trastuzumab-dttb from Samsung Bioepis Co. Ltd. (Incheon, Korea), a biosimilar of Herceptin. The biosimilar is Samsung Bioepis' first approved in the U.S. to treat cancer. Ontruzant received approval for...
16:55 , Jan 22, 2019 |  BC Extra  |  Company News

Samsung's Herceptin biosimilar gains U.S. approval

FDA approved a BLA for Ontruzant trastuzumab-dttb from Samsung Bioepis Co. Ltd. (Incheon, Korea), a biosimilar of Herceptin. The biosimilar is Samsung Bioepis' first approved in the U.S. to treat cancer. Ontruzant received approval for...
14:04 , Jan 18, 2019 |  BC Extra  |  Company News

FDA delays approval of Immunomedics' ADC for triple-negative breast cancer

Immunomedics Inc. (NASDAQ:IMMU) said FDA issued a complete response letter for its BLA for sacituzumab govitecan (IMMU-132) to treat metastatic triple-negative breast cancer in a third-line setting. The company was seeking accelerated approval of the...
00:23 , Jan 12, 2019 |  BioCentury  |  Finance

We all fall down

After an exuberant third quarter that put biotech indexes near their 2015 highs, all market cap tiers fell in 4Q18, eliminating the first nine month’s gains and losing $291.2 billion in aggregate value. Median losses...
17:53 , Jan 11, 2019 |  BC Week In Review  |  Company News

Regulatory reforms in China spark Samsung Bioepis deal with 3SBio

The regulatory reforms and growing China biopharma market has led South Korean company Samsung Bioepis Co. Ltd. (Incheon, South Korea) to expand its commercial reach via a deal with 3SBio Inc. (HKSE:1530). Samsung Bioepis said...
00:59 , Jan 8, 2019 |  BC Extra  |  Company News

Regulatory reforms in China spark Samsung Bioepis deal with 3SBio

The regulatory reforms and growing China biopharma market has led South Korean company Samsung Bioepis Co. Ltd. (Incheon, South Korea) to expand its commercial reach via a deal with 3SBio Inc. (HKSE:1530). Samsung Bioepis said...
20:14 , Dec 21, 2018 |  BC Week In Review  |  Financial News

Shanghai Henlius up for Hong Kong IPO

Biosimilars company Shanghai Henlius Biotech Inc. (Shanghai, China) proposed on Dec. 14 to list on the Hong Kong stock exchange. Shanghai Henlius' lead compound is HLX01, a biosimilar of cancer and autoimmune drug MabThera rituximab...
00:06 , Dec 15, 2018 |  BC Extra  |  Financial News

Shanghai Henlius up for Hong Kong IPO

Biosimilars company Shanghai Henlius Biotech Inc. (Shanghai, China) proposed on Friday to list on the Hong Kong stock exchange. Shanghai Henlius' lead compound is HLX01, a biosimilar of cancer and autoimmune drug MabThera rituximab from...