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1810 items
5:08 PM, Jul 20, 2018  |  BioCentury | Product Development

Getting to the point in IBS

A large epidemiological study set Ironwood Pharmaceuticals Inc. on a path to finding symptomatic outcomes important to IBS-C patients. The company’s new Phase IIIb study of Linzess linaclotide will probe those outcomes, seeking results that...
7:23 PM, Jun 29, 2018  |  BioCentury | Product Development

Defining access potential - before it’s too late

We see it everywhere: confirmation bias. Innovators believe in a drug, find the evidence to support its value, and dismiss or ignore the facts challenging their preferred story. But confirmation bias is particularly problematic thanks...
8:35 PM, Jun 15, 2018  |  BioCentury | Product Development

MATCH’s long game

Although three of the first four arms in NCI-MATCH missed their endpoints, the results suggest the basket trial is doing what it is supposed to -- finding efficacy signals in rare cancers. It’s also yielded...
5:25 PM, Jun 15, 2018  |  BioCentury | Product Development

NSCLC disrupted

This year’s ASCO made clear that PD-1 inhibitors have supplanted chemotherapy as standard of care in first-line metastatic NSCLC. The unanticipated consequence is the knock-on effects for companies with studies under way in both first-...
7:02 PM, Jun 08, 2018  |  BioCentury | Product Development

POC for cytokines

A body of clinical evidence is emerging that two different approaches to immune-stimulating cytokine therapies could increase efficacy of PD-1 inhibitors in both hot and cold tumors. Oncologists who spoke to BioCentury said, taken together, data...
6:43 PM, Jun 08, 2018  |  BioCentury | Product Development

Past not prologue

Loxo Oncology Inc.’s two-year streak of stunning data at ASCO appears to be the result of good decisions on the back of a healthy dose of luck. But it will be a tall order to...
5:24 PM, Jun 05, 2018  |  BioCentury | Product Development

Second (Ex)act

Armed with Phase II data for its second DNA methylation test, Exact Sciences Corp. expects a repeat performance of the rapid launch trajectory its Cologuard colorectal cancer screening assay has enjoyed. Cologuard beat expectations for...
10:50 PM, Jun 01, 2018  |  BioCentury | Product Development

Breaking from the herd

Behind the block of clinical studies on PD-1 and PD-L1 inhibitors, researchers are casting aside their herd mentality with a wide net of strategies to solve some of the most pressing problems in oncology, such...
6:30 PM, Jun 01, 2018  |  BioCentury | Product Development

ASCO: Pushing precision’s evolution

As the list of targeted therapies gaining approval grows, encompassing an increasingly broad spectrum of cancers, this year’s ASCO meeting aims to educate clinicians about how to determine which drugs are best in class for...
6:01 AM, May 25, 2018  |  BioCentury | Product Development

Patients at the core

With excitement mounting for the seven hemophilia gene therapies in the clinic, the National Hemophilia Foundation wanted to avoid a scenario in which patients, physicians and payers had no good way to compare them. The foundation...