18:31 , Sep 7, 2018 |  BC Week In Review  |  Clinical News

Chinese regulators reviewing pair of BeiGene therapies

BeiGene Ltd. (NASDAQ:BGNE; HKSE:6160) said Aug. 31 that China's National Medical Products Administration accepted an NDA for anti-PD-1 mAb tislelizumab (BGB-A317) to treat relapsed or refractory classical Hodgkin lymphoma (cHL). The news follows BeiGene's Aug....
19:19 , Aug 31, 2018 |  BC Extra  |  Company News

Chinese regulators reviewing pair of BeiGene therapies

BeiGene Ltd. (NASDAQ:BGNE; HKSE:6160) said Friday that China's National Medical Products Administration accepted an NDA for anti-PD-1 mAb tislelizumab (BGB-A317) to treat relapsed or refractory classical Hodgkin lymphoma (cHL). The news follows BeiGene's Aug. 26...
00:46 , Aug 4, 2018 |  BioCentury  |  Finance

Functions of formulation

Halozyme Therapeutics Inc. is quickly expanding the reach of its Enhanze platform on the back of regulatory approvals for products that are now gaining market share, plus a playbook for streamlined early development it can...
16:40 , Aug 3, 2018 |  BC Week In Review  |  Financial News

BeiGene prices Hong Kong listing

BeiGene Ltd. (NASDAQ:BGNE) raised on Aug. 2 HK$7.1 billion (US$902.7 million) through the sale of 65.6 million shares at HK$108 in its listing on the Hong Kong stock exchange. BeiGene, which priced the offering toward...
18:30 , Jul 27, 2018 |  BC Extra  |  Financial News

BeiGene's proposed HKEX listing could rake in over $900M

BeiGene Ltd. (NASDAQ:BGNE) proposed to raise up to HK$7.3 billion ($932.7 million) in a follow-on on the Hong Kong stock exchange through the sale of 65.6 million shares at HK$94.40-HK$111.60. At the HK$103 midpoint, BeiGene...
18:57 , Jul 13, 2018 |  BC Week In Review  |  Clinical News

Keytruda under Priority Review for first-line squamous NSCLC

Merck & Co. Inc. (NYSE:MRK) said FDA accepted and granted Priority Review to an sBLA for Keytruda pembrolizumab plus carboplatin/paclitaxel or Abraxane nab-paclitaxel as first-line treatment of metastatic squamous non-small cell lung cancer regardless of...
16:44 , Jul 6, 2018 |  BC Week In Review  |  Clinical News

Tecentriq meets PFS endpoint in first-line TNBC

Genentech Inc. said Tecentriq atezolizumab met the co-primary endpoint of improving progression-free survival (PFS) in the Phase III IMpassion130 trial as first-line treatment of triple-negative breast cancer (TNBC). The Roche (SIX:ROG; OTCQX:RHHBY) unit said the...
17:57 , Jul 2, 2018 |  BC Extra  |  Company News

Keytruda under Priority Review for first-line squamous NSCLC

Merck & Co. Inc. (NYSE:MRK) said FDA accepted and granted Priority Review to an sBLA for Keytruda pembrolizumab plus carboplatin/paclitaxel or Abraxane nab-paclitaxel...
14:51 , Jul 2, 2018 |  BC Extra  |  Clinical News

Tecentriq meets PFS endpoint in first-line TNBC

Genentech Inc. said Tecentriq atezolizumab met the co-primary endpoint of improving progression-free survival in the Phase III IMpassion130 trial as first-line treatment of triple-negative breast cancer. The Roche (SIX:ROG; OTCQX:RHHBY) unit said the data are...
14:28 , Jun 29, 2018 |  BC Week In Review  |  Clinical News

Merrimack discontinues pancreatic cancer candidate after Phase II miss

Merrimack Pharmaceuticals Inc. (NASDAQ:MACK) reported that first-line treatment with istiratumab (MM-141) missed the primary and secondary endpoints in the Phase II CARRIE trial to treat metastatic pancreatic cancer. The company said it will discontinue the...