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...
15:14 , Jun 8, 2018 |  BC Week In Review  |  Clinical News

Roche scraps taselisib plans based on ASCO data

Roche (SIX:ROG; OTCQX:RHHBY) and its Genentech Inc. unit said they will not seek approval for taselisib after the Phase III SANDPIPER study to treat metastatic breast cancer showed that the molecule provided limited benefit. However,...
12:28 , Jun 2, 2018 |  BC Extra  |  Clinical News

Roche scraps taselisib plans based on ASCO data

Roche (SIX:ROG; OTCQX:RHHBY) and its Genentech Inc. unit said they will not seek approval for taselisib after the Phase III SANDPIPER study to treat metastatic breast cancer showed that the molecule provided limited benefit. However,...
20:34 , Apr 27, 2018 |  BC Week In Review  |  Financial News

Mereo postpones NASDAQ listing

Mereo BioPharma Group plc (LSE:MPH) said on April 26 it postponed an offering to list its ADSs on NASDAQ and withdrew a concurrent placing, citing market conditions. According to an April 9 SEC filing, the company...
23:09 , Apr 6, 2018 |  BioCentury  |  Finance

Fundamentally driven

Continued struggles by the mega-cap bellwethers and the resurgence of volatility in global equity markets were the major themes of 1Q18, whipsawing biotech stocks throughout the quarter but leaving index values little changed on the...
17:17 , Mar 23, 2018 |  BC Week In Review  |  Clinical News

Mereo's BGS-649 meets in Phase IIb for hypogonadism

Mereo BioPharma Group plc (LSE:MPH) reported top-line data from a Phase IIb trial in 271 obese men with hypogonadotropic hypogonadism showing that all three doses of once-weekly oral BGS-649 met the primary endpoint of normalizing...
00:33 , Mar 2, 2018 |  BC Week In Review  |  Clinical News

FDA approves Lilly's Verzenio as first-line endocrine therapy

Eli Lilly and Co. (NYSE:LLY) said FDA approved Verzenio abemaciclib as first-line endocrine therapy in combination with an aromatase inhibitor to treat hormone receptor-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women. The approval was...
00:08 , Feb 27, 2018 |  BC Extra  |  Company News

FDA approves Lilly's Verzenio as first-line endocrine therapy

Eli Lilly and Co. (NYSE:LLY) said FDA approved Verzenio abemaciclib as first-line endocrine therapy in combination with an aromatase inhibitor to treat hormone receptor-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women. The approval was...