23:05 , Jul 31, 2019 |  BC Extra  |  Clinical News

July 31 Clinical Quick Takes: Novartis' Kisqali shows OS benefit; plus Atlantic and Translate Bio

Kisqali improves survival for postmenopausal breast cancer  Novartis AG (NYSE:NVS; SIX:NOVN) reported interim data showing CDK4/CDK6 inhibitor Kisqali ribociclib plus fulvestrant met the secondary endpoint of significantly improved overall survival in the Phase III MONALEESA-3...
00:19 , Jul 31, 2019 |  BC Extra  |  Clinical News

July 30 Clinical Quick Takes: Biogen, Alkermes MS candidate superior to Tecfidera; plus Amgen, Lilly and more

Biogen, Alkermes Phase III MS candidate beats Tecfidera  Biogen Inc. (NASDAQ:BIIB) and Alkermes plc (NASDAQ:ALKS) said diroximel fumarate (BIIB098) met the primary endpoint in the Phase III EVOLVE-MS-2 trial: superiority to Biogen’s Tecfidera dimethyl fumarate...
01:37 , Jun 28, 2019 |  BC Innovations  |  Product Development

How Array stayed alive long enough to grow up

Array’s 21-year journey as an independent platform company, culminating in an $11.4 billion buyout, required shifting focus from research to development and back again. The acquisition sends a message that developing focused expertise and sticking...
23:45 , Jun 19, 2019 |  BC Extra  |  Clinical News

June 19 Clinical Quick Takes: G1 jumps on breast cancer data; plus Linzess, Lokelma, Boehringer/OSE, GCAR and more

G1 rises on trilaciclib OS efficacy in Phase II for TNBC  G1 Therapeutics Inc. (NASDAQ:GTHX) has gained 33% to $26.27 since reporting preliminary data Tuesday from a Phase II trial showing a statistically significant improvement...
21:21 , Jun 14, 2019 |  BioCentury  |  Product Development

Despite senior management shake-up, Novartis’ pipeline is primed to deliver

A string of departures at Novartis AG and strategic shifts by new CEO Vasant Narasimhan have produced a fairly thorough makeover of the executive committee he inherited in 2018. The team gains a pipeline that...
00:31 , Jun 4, 2019 |  BC Innovations  |  Distillery Therapeutics

Dual inhibition of CDK4 and CDK6 for pulmonary arterial hypertension

DISEASE CATEGORY: Cardiovascular INDICATION: Hypertension Patient sample and rat studies suggest dual inhibition of CDK4 and CDK6 could help treat pulmonary arterial hypertension (PAH). In lung samples from patients with idiopathic PAH, protein levels of...
23:20 , Jun 3, 2019 |  BC Extra  |  Clinical News

June 3 ASCO Quick Takes: ORR of 32% for Celgene's iberdomide in MM; plus Five Prime, Iovance and more

Celgene highlights iberdomide data for MM at ASCO  Celgene Corp. (NASDAQ:CELG) presented data at ASCO Sunday showing that iberdomide (CC-220) plus dexamethasone led to an overall response rate (ORR) of 32%, including 17 partial responses...
01:12 , Jun 1, 2019 |  BioCentury  |  Product Development

Clinical trial and regulatory efficiency get help from ctDNA, RWE at ASCO19

This year’s crop of ASCO abstracts show companies are going full bore on pre- and post-market technologies that can speed up development and regulatory timelines. In BioCentury’s analysis of 4,627 abstracts, over 500 feature circulating...
17:22 , Apr 19, 2019 |  BC Week In Review  |  Company News

FDA approves Ibrance for men with breast cancer

Pfizer said FDA approved an sNDA for Ibrance palbociclib based on real-world data to treat hormone receptor-positive, HER2-negative advanced or metastatic breast cancer in men in combination with an aromatase inhibitor or fulvestrant. Pfizer Inc....
23:51 , Feb 21, 2019 |  BC Week In Review  |  Company News

HaiHe forms joint venture with CSPC, narrows focus to oncology

Shanghai HaiHe Biopharma Co. Ltd. (Shanghai, China) formed a joint venture with CSPC Pharmaceutical Group Ltd. (HKSE:1093) to develop and commercialize five of HaiHe’s programs, mostly outside of oncology. Financial terms were not disclosed. HaiHe...