19:50 , Nov 2, 2018 |  BC Week In Review  |  Clinical News

Syndax's entinostat misses PFS endpoint in Phase III for breast cancer

Syndax Pharmaceuticals Inc. (NASDAQ:SNDX) reported that entinostat (SNDX-275) missed the primary endpoint of improving progression-free survival (PFS) in the Phase III E2112 trial to treat breast cancer. The company said the trial will continue as...
17:37 , Oct 26, 2018 |  BC Extra  |  Clinical News

Syndax slides on entinostat PFS miss in breast cancer

Syndax Pharmaceuticals Inc. (NASDAQ:SNDX) fell $1.03 (17%) to $5.01 Friday after reporting late Thursday that entinostat missed the primary endpoint of improving progression-free survival in the Phase III E2112 trial to treat breast cancer. The...
19:04 , Dec 8, 2017 |  BC Week In Review  |  Clinical News

Kyowa starts Phase II of entinostat

In October, Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) began a Phase II trial of entinostat (KHK2375, SNDX-275) in combination with exemestane in about 124 patients with advanced or recurrent hormone receptor-positive, HER2-negative breast cancer. The...
23:23 , Dec 1, 2017 |  BC Extra  |  Clinical News

Bayer reports mortality signal with Xofigo in early CRPC

Bayer AG (Xetra:BAYN) said an IDMC observed more fractures and deaths among patients treated with Xofigo radium-223 dichloride vs. placebo in the Phase III ERA223 trial to treat metastatic castration-resistant prostate cancer. Bayer said it...
20:21 , Oct 17, 2017 |  BC Extra  |  Company News

Syndax in menin-MLL deal with Allergan

Syndax Pharmaceuticals Inc. (NASDAQ:SNDX) obtained an exclusive, worldwide license to inhibitors of the menin-MLL fusion oncogene from the Vitae Pharmaceuticals Inc. subsidiary of Allergan plc (NYSE:AGN). Syndax plans to begin clinical trials in 2019 of...
22:46 , Nov 17, 2016 |  BC Week In Review  |  Company News

Afinitor sales and marketing update

The U.K.'s NICE issued a final appraisal determination (FAD) recommending the use of Afinitor everolimus from Novartis in combination with exemestane to treat advanced EGFR2 ( HER2 ; ErbB2 ; neu)-negative, hormone receptor-positive breast cancer....
07:00 , Aug 22, 2016 |  BC Week In Review  |  Company News

Novartis sales and marketing update

The U.K.’s NICE issued draft guidance recommending against the use of Afinitor everolimus because it “did not have plausible potential to be cost effective,” even when offered an undisclosed discount under a patient access scheme,...
07:00 , Aug 17, 2016 |  BC Extra  |  Company News

NICE recommends removal of two drugs from CDF

The U.K.'s NICE issued preliminary draft guidances recommending the removal of two drugs from coverage by the country's Cancer Drugs Fund (CDF) for specific indications. NICE said Afinitor from Novartis AG (NYSE:NVS; SIX:NOVN) "did not...
07:00 , May 23, 2016 |  BioCentury  |  Strategy

Two heads are better

With Gleevec imatinib off patent, flagging ophthalmics sales and at least one slower than expected launch, Novartis AG is consolidating operations at the top to cut costs, while also splitting its R&D into two buckets:...
07:00 , Jun 16, 2014 |  BC Week In Review  |  Clinical News

MM-121: Additional Phase II data

Additional data from a double-blind, placebo-controlled, international Phase II trial in 115 patients who have failed anti-estrogen therapy showed that IV MM-121 plus oral Aromasin exemestane led to a median PFS, the primary endpoint, of...