01:30 , Jul 13, 2019 |  BioCentury  |  Tools & Techniques

Broadening role for external control arms in clinical trials

External control arms are moving from theory to practice as drug developers begin to use them to make internal go/no-go decisions for clinical programs and to support regulatory applications. The field is largely split between...
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...
18:56 , Jun 17, 2019 |  BC Extra  |  Company News

Array takeout buoys biotechs, strengthens Pfizer in targeted oncology

Public biotechs got a boost Monday on the strength of Pfizer's $11.4 billion buyout of Array, signaling that continued M&A interest in the sector can help reverse the loss in momentum that has led to...
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...
18:10 , May 2, 2019 |  BioCentury  |  Politics, Policy & Law

Gottlieb: How a cultural shift is transforming FDA’s drug reviews

A decade ago, the FDA secured new tools, resources, and authorities to implement a watershed change in how the agency approached the drug review process. The novel framework turned on a more active approach to...
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....
00:48 , Feb 1, 2019 |  BC Week In Review  |  Company News

Pfizer launches China's first pay-for-performance model for cancer

Pfizer Inc. (NYSE:PFE) launched a pay-for-performance insurance program for its breast cancer drug Ibrance palbociclib in China on Jan 23. The program is the nation's first pay-for-performance insurance for oncology and covers 34 Chinese cities,...
22:16 , Jan 25, 2019 |  BC Extra  |  Company News

Pfizer launches China's first pay-for-performance model for cancer

Pfizer Inc. (NYSE:PFE) launched a pay-for-performance insurance program for its breast cancer drug Ibrance palbociclib in China. The program is the nation's first pay-for-performance insurance for oncology and covers 34 Chinese cities, according to state-run...