00:05 , Aug 9, 2019 |  BC Innovations  |  Tools & Techniques

The next frontier for single-cell analysis

With an explosion in scalability, single-cell analysis has begun to invade every aspect of drug development, with early benefits showing themselves in precision targeting. The field’s next challenge is to integrate a wider array of...
21:31 , Aug 8, 2019 |  BC Innovations  |  Distillery Techniques

Organ-on-a-chip model for testing cystic fibrosis therapies

TECHNIQUES CATEGORY: Disease models TECHNOLOGY: Cell models; 3D models A patient-derived, dual chamber, chip-based model of cystic fibrosis (CF) could be used to test therapies for CF-related diabetes, a common complication of CF. The model...
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...
23:16 , Jun 21, 2019 |  BC Extra  |  Company News

June 21 Company Quick Takes: FDA rejects Daiichi's AML candidate; plus Sanofi, Novartis and more

Complete response letter for Daiichi's quizartinib  Daiichi Sankyo Co. Ltd. (Tokyo:4568) said FDA issued a complete response letter for quizartinib, its candidate to treat relapsed/refractory FLT3-ITD-positive acute myelogenous leukemia (AML). In May, an FDA advisory...
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...
00:28 , Jun 7, 2019 |  BioCentury  |  Product Development

How early biomarkers and constant iteration fuel Vertex's R&D efficiency

As Vertex prepares its fourth NDA for a cystic fibrosis drug in six years, EVP of Global Research and CSO David Altshuler credits the biotech’s R&D efficiency to a focus on agents that show more...
20:24 , May 30, 2019 |  BC Extra  |  Clinical News

Why Vertex picked elexacaftor for CF triple combo regimen

Vertex said it selected elexacaftor (VX-445) as the third component of its cystic fibrosis combination therapy after reporting updated Phase III data on Thursday. The company reiterated its plans to submit an NDA to FDA...
22:37 , May 23, 2019 |  BC Extra  |  Company News

Impasse over Vertex CF drugs likely to continue despite NHS’s managed access offer

Despite including a key request from CF patient advocacy groups' wish list, a fresh proposal from NHS England is unlikely to break the three-year-long stalemate over access to Vertex's cystic fibrosis drugs. NHS England's new...
00:00 , May 17, 2019 |  BC Innovations  |  Product Development

Abeona tackles gene therapy’s problems in cystic fibrosis with chimeric AAVs

As it builds up its preclinical pipeline, Abeona is switching gears to create chimeric AAV vectors that it hopes will do a better job than naturally occurring ones of dialing in the right properties for...
00:02 , May 1, 2019 |  BC Extra  |  Company News

April 30 Company Quick Takes: Merck, G1, Pfizer, Amgen and more

Merck sales rise in China Merck & Co. Inc. (NYSE:MRK) said product sales in China were $725 million for 1Q19, up 67% on an ex-exchange basis from 1Q18 and driven by products in its vaccines...