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1814 items
5:00 PM, Sep 07, 2018  |  BioCentury | Product Development

Data distribution

TransCelerate BioPharma Inc. is taking its data sharing initiative to the next level with a new platform that will integrate clinical and preclinical data sets in a single repository and provide new analytical tools. DataCelerate,...
6:59 PM, Aug 17, 2018  |  BioCentury | Product Development

Agreement to differ

FDA’s approval of Alnylam’s Onpattro marks the start of a showdown in the Orphan disease hATTR amyloidosis, with Akcea’s Tegsedi likely coming to the U.S. market in less than two months. Alnylam has used its...
5:11 PM, Aug 17, 2018  |  BioCentury | Product Development

Doing more with less

In rare diseases where natural history data are scarce, Phase II studies may have to perform dual duty to both seek efficacy signals and test out new endpoints. Ovid Therapeutics Inc. and Clementia Pharmaceuticals Inc....
5:00 PM, Aug 10, 2018  |  BioCentury | Product Development

Exacerbation management

Based on work spearheaded by the Cystic Fibrosis Foundation, Corbus Pharmaceuticals Holdings Inc. will be the first company to attempt to gain approval in CF based on pulmonary exacerbations instead of FEV1. The company is...
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...