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...
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...
15:40 , Apr 27, 2018 |  BC Week In Review  |  Clinical News

G1 reports Phase IIa data for trilaciclib as first-line treatment of SCLC

G1 Therapeutics Inc. (NASDAQ:GTHX) reported top-line data from 77 treatment-naïve patients with extensive-stage small cell lung cancer (SCLC) in the double-blind Phase IIa portion of the international Phase Ib/IIa G1T28-02 trial showing that first-line treatment...
03:45 , Apr 13, 2018 |  BC Innovations  |  Targets & Mechanisms

Meeting the burden

A major theme at this year’s AACR is the abundance of preclinical discovery driven by molecular signatures in patient samples, suggesting the research community is heeding the call for studies better grounded in human data,...
23:15 , Mar 20, 2018 |  BC Innovations  |  Distillery Techniques

Biomarkers

TECHNOLOGY: SNPs; Plasma markers A plasma cfDNA mutation on PI3KCA could help predict resistance to combined inhibition of MEK, CDK4 and CDK6 in NRAS-mutant melanoma. In samples from a patient with metastatic NRAS-mutant melanoma treated with...
23:13 , Mar 20, 2018 |  BC Innovations  |  Distillery Techniques

Biomarkers

TECHNOLOGY: SNPs; plasma markers Serum tumor-derived cfDNA mutations on PI3KCA could help predict survival in breast cancer patients receiving Ibrance palbociclib and Faslodex fulvestrant. In 52 patients treated with a combination of Ibrance and Faslodex, high...