17:06 , Aug 3, 2018 |  BC Week In Review  |  Clinical News

CHMP positive on patisiran, Symkevi, Humira and Neulasta biosimilars

EMA's CHMP recommended a number of approvals July 26, including Onpattro patisiran from Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY), Symkevi tezacaftor/ivacaftor from Vertex Pharmaceuticals Inc. (NASDAQ:VRTX), a handful of cancer therapies and three biosimilars. The committee recommended approval...
22:08 , Jul 27, 2018 |  BC Extra  |  Company News

CHMP positive on patisiran, Symkevi, Humira and Neulasta biosimilars

EMA's CHMP recommended a number of approvals Friday, including Onpattro patisiran from Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY), Symkevi tezacaftor/ivacaftor from Vertex Pharmaceuticals Inc. (NASDAQ:VRTX), a handful of cancer therapies and three biosimilars. The committee recommended approval of...
17:57 , Jul 20, 2018 |  BC Week In Review  |  Company News

Takeda, Ovid expand TAK-935 collaboration with three new trials

Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) and Ovid Therapeutics Inc. (NASDAQ:OVID) expanded their collaboration for TAK-935 (OV935) to include three new trials in pediatric populations, including in two additional rare epilepsy syndromes. The partners expect to...
20:49 , Jul 18, 2018 |  BC Extra  |  Company News

FDA real-time pilot speeds Kisqali label expansion

FDA announced on Wednesday that it approved Kisqali ribociclib from Novartis AG (NYSE:NVS; SIX:NOVN) in combination with an aromatase inhibitor for breast cancer in premenopausal and perimenopausal women in the first-line setting, five months ahead...
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)...
18:04 , Jun 29, 2018 |  BC Week In Review  |  Clinical News

Pfizer's Ibrance fails to improve OS in Phase III for breast cancer

Pfizer Inc. (NYSE:PFE) said Ibrance palbociclib plus Faslodex fulvestrant failed to significantly improve overall survival (OS), a secondary endpoint, vs. placebo plus Faslodex in the Phase III PALOMA-3 trial to treat hormone receptor-positive, HER2-negative metastatic...
17:45 , Jun 1, 2018 |  BC Week In Review  |  Clinical News

G1 reports Phase Ib data for G1T38 in breast cancer

G1 Therapeutics Inc. (NASDAQ:GTHX) reported preliminary data from 24 estrogen receptor-positive, HER2-negative breast cancer patients in the Phase Ib portion of a Phase Ib/IIa trial showing that G1T38 plus Faslodex fulvestrant led to a partial...
14:11 , May 18, 2018 |  BC Week In Review  |  Clinical News

Immunomedics reports Phase I/II metastatic breast cancer data for sacituzumab govitecan

Immunomedics Inc. (NASDAQ:IMMU) said sacituzumab govitecan (IMMU-132) led to an overall response rate (ORR) of 31% in a cohort of 54 patients with estrogen receptor-positive, HER2-negative metastatic breast cancer in the Phase I/II IMMU-132-01 trial....
20:46 , May 17, 2018 |  BC Extra  |  Clinical News

Immunomedics reports Phase I/II metastatic breast cancer data

Immunomedics Inc. (NASDAQ:IMMU) said sacituzumab govitecan (IMMU-132) led to an overall response rate (ORR) of 31% in a cohort of 54 patients with estrogen receptor-positive, HER2-negative metastatic breast cancer in the Phase I/II IMMU-132-01 trial....
15:22 , May 9, 2018 |  BC Innovations  |  Distillery Therapeutics

Cancer

INDICATION: Breast cancer Patient sample and cell culture studies suggest inhibiting BARD1, BRCA1, CDK1 or CKD12 could help treat tamoxifen-resistant breast cancer. In tumor tissue from 27 recurrent breast cancer patients whose tumors became resistant...