02:58 , Sep 1, 2018 |  BioCentury  |  Politics, Policy & Law

Stepping Through

Once considered obstacles to biomedical product development, regulators around the world have become enablers of the kinds of scientific and economic innovations that will underpin new business models. They are building gateways that could help...
18:56 , Aug 31, 2018 |  BC Week In Review  |  Clinical News

Novartis' PI3Kα inhibitor meets in Phase III for breast cancer

Novartis AG (NYSE:NVS; SIX:NOVN) said alpelisib (BYL719) met the primary endpoint in the Phase III SOLAR-1 trial to treat advanced breast cancer in previously treated patients that harbor the phosphoinositide 3-kinase (PI3K) catalytic subunit α...
21:36 , Aug 23, 2018 |  BC Extra  |  Clinical News

Novartis' PI3Kα inhibitor meets in Phase III for breast cancer

Novartis AG (NYSE:NVS; SIX:NOVN) said alpelisib (BYL719) met the primary endpoint in the Phase III SOLAR-1 trial to treat advanced breast cancer in previously treated patients that harbor the phosphoinositide 3-kinase (PI3K) catalytic subunit α...
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...