17:22 , Jul 27, 2018 |  BC Week In Review  |  Company News

Lee's mulls spin off, HK IPO for China oncology subsidiary

Lee's Pharmaceutical Holdings Ltd. (HKSE:950) said it will consolidate its oncology development pipeline into its China Oncology Focus Ltd. (COF) subsidiary. Lee's CFO Jason Chow told BioCentury that the company expects the reorganization to potentiate...
19:06 , Apr 13, 2018 |  BC Week In Review  |  Clinical News

China advisory committee to review CASI's multiple myeloma therapy

CASI Pharmaceuticals Inc. (NASDAQ:CASI) said China's Expert Advisory Anti-Tumor (Oncology) Drugs Committee will meet to review an application for CASI's Evomela melphalan to treat multiple myeloma. China FDA's Center for Drug Evaluation told CASI the...
21:06 , Apr 6, 2018 |  BioCentury  |  Finance

Smid-cap smorgasbord

While the biggest milestone of the second quarter came early and turned out to be a disappointment, investors still have plenty to look forward to in immuno-oncology. In addition, specialist investors’ current strategy of overweighting...
22:06 , Feb 23, 2018 |  BC Extra  |  Company News

Darzalex guidance buoys Genmab shares

Genmab A/S (CSE:GEN; Pink:GMXAY) gained DKK13.6 billion ($2.3 billion) in market cap across two days of trading after issuing an earnings report that included new 2018 guidance for multiple myeloma (MM) drug Darzalex daratumumab. Based...
16:20 , Jan 26, 2018 |  BC Week In Review  |  Clinical News

FDA grants Darzalex Priority Review for first-line MM

Genmab A/S (CSE:GEN; Pink:GMXAY) said FDA accepted and granted Priority Review to an sBLA from partner Johnson & Johnson (NYSE:JNJ) for Darzalex daratumumab to treat multiple myeloma in the first-line setting. The PDUFA date is...
23:53 , Jan 19, 2018 |  BC Extra  |  Company News

FDA grants Darzalex Priority Review for first-line MM

Genmab A/S (CSE:GEN; Pink:GMXAY) said FDA accepted and granted Priority Review to an sBLA from partner Johnson & Johnson (NYSE:JNJ) for Darzalex daratumumab to treat multiple myeloma in the first-line setting. The PDUFA date is...
00:01 , Dec 1, 2017 |  BC Week In Review  |  Clinical News

J&J seeking first-line MM indication for Darzalex

Johnson & Johnson (NYSE:JNJ) submitted applications in both the U.S. and EU seeking to push Darzalex daratumumab (HuMax-CD38) into the first-line setting to treat multiple myeloma. On Nov. 21, the pharma said it submitted an sBLA...
22:25 , Nov 21, 2017 |  BC Extra  |  Company News

J&J seeking first-line MM indication for Darzalex

Johnson & Johnson (NYSE:JNJ) submitted applications in both the U.S. and EU seeking to push Darzalex daratumumab into the first-line setting to treat multiple myeloma. On Tuesday, the pharma said it submitted an sBLA to FDA...
19:01 , Oct 27, 2017 |  BC Week In Review  |  Financial News

CASI raises $23.9M in registered direct offering

On Oct. 13, CASI Pharmaceuticals Inc. (NASDAQ:CASI) raised $23.9 million through the sale of 8 million units at $3 in a registered direct offering led by existing stakeholders. Each unit comprises a share and two-and-a-half...
23:10 , Aug 28, 2017 |  BC Week In Review  |  Clinical News

Genmab's Darzalex meets in Phase III for first-line MM

Genmab A/S (CSE:GEN; Pink:GMXAY) reported top-line data from a pre-planned interim analysis of the Phase III ALCYONE (MMY3007) trial showing that Darzalex daratumumab (HuMax-CD38) plus Velcade bortezomib, melphalan and prednisone (VMP) as first-line treatment of...