BioCentury | Jun 4, 2020
Product Development

June 3 Quick Takes: Double double for BeiGene’s Brukinsa; plus Novartis, Merck-Vaxxas, Antibe, Mirum and more

BeiGene’s BTK inhibitor gets first China approval  BeiGene Ltd. (NASDAQ:BGNE; HKEX:6160) said China’s National Medical Products Administration approved Brukinsa zanubrutinib in two cancer indications: chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and mantle cell lymphoma...
BC Extra | Nov 15, 2019
Company News

BeiGene enters U.S. market with first approval for in-house pipeline

With its first approval for an internally developed drug, BeiGene faces tough competition as it seeks to carve out a niche for Brukinsa. But the third-to-market Btk inhibitor could have an edge on efficacy without...
BC Extra | Aug 23, 2019
Company News

BeiGene's first U.S. NDA tests global development strategy

BeiGene believes inclusion of data from trials run in China in the company’s first NDA to be reviewed by FDA could help build industry’s confidence in doing trials in China. BeiGene also hopes the strategy...
BC Extra | Aug 23, 2019
Company News

Aug. 22 Company Quick Takes: Innovent, Lilly in biologics deal; plus Sobi, Gilead, Themis-Merck, Iconic-Novartis, GW, BeiGene, Clearside, Inex Innovations

Innovent, Lilly in third biologics deal  Innovent Biologics Inc. (HKEX:1801) in-licensed Chinese rights to OXM3 from Eli Lilly and Co. (NYSE:LLY) to treat diabetes. The oxyntomodulin analog -- a dual agonist of GLP-1R and GCGR...
BC Extra | Jun 19, 2019
Clinical News

June 19 Clinical Quick Takes: G1 jumps on breast cancer data; plus Linzess, Lokelma, Boehringer/OSE, GCAR and more

G1 rises on trilaciclib OS efficacy in Phase II for TNBC  G1 Therapeutics Inc. (NASDAQ:GTHX) has gained 33% to $26.27 since reporting preliminary data Tuesday from a Phase II trial showing a statistically significant improvement...
BC Extra | Jun 14, 2019
Clinical News

June 14 Clinical Quick Takes: Chi-Med, BeiGene, UCB, Global Blood and more

Chi-Med’s surufatinib meets in Phase III for extra-pancreatic neuroendocrine tumors  Hutchison China MediTech Ltd. (LSE:HCM; NASDAQ:HCM) said it is planning a pre-NDA meeting with China’s National Medical Products Administration (NMPA) after surufatinib (formerly sulfatinib) met...
BioCentury | Jun 8, 2019
Product Development

ASCO 2019 sessions provide guidance on expanding patient pools for clinical trials

Two sessions at this year's American Society of Clinical Oncology meeting gave drug developers a glimpse of how to match more patients to clinical trials by broadening eligibility criteria and encouraging trial enrollment in community...
BC Week In Review | Jan 18, 2019
Clinical News

BeiGene's BTK inhibitor gets U.S. breakthrough designation

BeiGene Ltd. (NASDAQ:BGNE; HKSE:6160) said FDA granted breakthrough therapy designation to zanubrutinib (BGB-3111) to treat second-line mantle cell lymphoma (MCL). BeiGene President and General Manager of China Xiaobing Wu told BioCentury zanubrutinib is the first...
BC Extra | Jan 14, 2019
Company News

BeiGene's Btk inhibitor gets U.S. breakthrough designation

BeiGene Ltd. (NASDAQ:BGNE; HKSE:6160) said FDA granted breakthrough therapy designation to zanubrutinib (BGB-3111) to treat second-line mantle cell lymphoma (MCL). BeiGene President and General Manager of China Xiaobing Wu told BioCentury zanubrutinib is the first...
BioCentury | Jan 5, 2019
Finance

Ready to launch

  The proposed $74 billion takeout of Celgene Corp. by Bristol-Myers Squibb Co. will not shift buysider attention away from upcoming and maturing drug launches heading into 2019, with plenty to track following a record...
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