23:41 , Apr 19, 2019 |  BioCentury  |  Product Development

Companies poised to take Chinese checkpoints global

At least three companies are well positioned to answer FDA Oncology chief Richard Pazdur’s call to bring Chinese PD-1/PD-L1 inhibitors to the U.S. to compete on price. Two Chinese drugmakers and one U.S. company globally...
21:00 , Apr 12, 2019 |  BC Extra  |  Company News

J&J's Balversa gets accelerated approval for bladder cancer

FDA granted Janssen's Balversa erdafitinib accelerated approval to treat bladder cancer, making it the first FGFR kinase inhibitor to gain U.S. approval. Balversa is indicated to treat adults with locally advanced or metastatic urothelial carcinoma...
17:04 , Aug 3, 2018 |  BC Week In Review  |  Clinical News

Otsuka's guadecitabine misses in Phase III for first-line AML

Otsuka Pharmaceutical Co. Ltd. (Tokyo, Japan) and its Astex Pharmaceuticals Inc. subsidiary said first-line treatment with guadecitabine (formerly SGI-110) missed the co-primary endpoints in the Phase III ASTRAL-1 trial to treat previously untreated acute myelogenous...
17:41 , Jul 31, 2018 |  BC Extra  |  Clinical News

Otsuka's guadecitabine misses in Phase III for first-line AML

Otsuka Pharmaceutical Co. Ltd. (Tokyo, Japan) and its Astex Pharmaceuticals Inc. subsidiary said first-line treatment with guadecitabine (formerly SGI-110) missed the co-primary endpoints in the Phase III ASTRAL-1 trial to treat previously untreated acute myelogenous...
19:58 , Jul 13, 2018 |  BC Week In Review  |  Company News

Otsuka acquiring antibody play Visterra

Otsuka Pharmaceutical Co. Ltd. (Tokyo, Japan) is acquiring antibody developer Visterra Inc. (Waltham, Mass.) for $430 million in cash, the companies said on July 11. The deal gives Otsuka a pipeline based on Visterra's Hierotope...
18:50 , Jul 11, 2018 |  BC Extra  |  Company News

Otsuka acquiring antibody play Visterra

Otsuka Pharmaceutical Co. Ltd. (Tokyo, Japan) is acquiring antibody developer Visterra Inc. (Waltham, Mass.) for $430 million in cash, the companies said Wednesday. The deal gives Otsuka a pipeline based on Visterra's Hierotope platform, which...
21:35 , Jul 10, 2018 |  BC Innovations  |  Distillery Therapeutics

Cancer

INDICATION: Melanoma, colorectal cancer In vitro , cell culture and mouse studies identified an aminopyrimidine-based dual MAPK1/MAPK3 inhibitor that could help treat BRAF-mutant melanoma and colorectal cancer. Fragment-based screening, chemical synthesis and in vitro enzyme...
16:44 , Jul 6, 2018 |  BC Week In Review  |  Clinical News

Novartis' Kisqali combo meets PFS endpoint in Phase III for breast cancer in postmenopausal women

Novartis AG (NYSE:NVS; SIX:NOVN) reported data from the Phase III MONALEESA-3 trial to treat breast cancer showing that Kisqali ribociclib in combination with Faslodex fulvestrant met the primary endpoint of improving median progression-free survival (PFS)...
16:51 , Jun 8, 2018 |  BC Week In Review  |  Clinical News

J&J reports Phase II PFS and OS data for FGFR inhibitor in urothelial cancer

Johnson & Johnson (NYSE:JNJ) reported data from 99 evaluable patients with urothelial cancer in the Phase II BLC2001 trial showing that once-daily erdafitinib (JNJ-42756493) led to a median progression-free survival (PFS) of 5.5 months and...
19:10 , May 18, 2018 |  BC Week In Review  |  Clinical News

J&J highlights FGFR inhibitor data ahead of ASCO

Johnson & Johnson (NYSE:JNJ) unveiled for the first time data for its fibroblast growth factor receptor (FGFR) inhibitor, erdafitinib (JNJ-42756493). In the Phase II BLC2001 trial, erdafitinib led to a confirmed objective response rate (ORR)...