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1821 items
7:50 PM, Oct 19, 2018  |  BioCentury | Product Development

New shops for value-based deals

Value-based payment models are starting to appear beyond the high-profile insurers and PBMs that have dominated the scene, with a series of deals struck since August by the Oklahoma Health Care Authority and the University...
7:10 PM, Oct 19, 2018  |  BioCentury | Product Development

CVOT damage in diabetes

As FDA reconsiders its requirement for cardiovascular outcomes trials of new diabetes candidates, it’s clear that the development of new therapies has slowed since it was implemented. In December 2008, FDA issued guidance requiring diabetes...
9:17 PM, Oct 12, 2018  |  BioCentury | Product Development

Trevena goes for MOR than morphine

FDA’s Anesthetic and Analgesic Drug Products Advisory Committee meeting on pain candidate oliceridine from Trevena Inc. gave the agency little reason to reverse its skepticism about the molecule’s benefits and risks. But it did leave...
6:55 PM, Oct 12, 2018  |  BioCentury | Product Development

Bourla’s breadcrumbs to value

Incoming CEO Albert Bourla has spent only a few of his 25 years at Pfizer Inc. in the pharma’s innovative drugs business, but there are signs he already has laid the groundwork for innovating how...
8:46 PM, Sep 28, 2018  |  BioCentury | Product Development

Deferred differentiation in migraine

The best hope for CGRP antagonists to differentiate themselves lies in data that aren’t yet available. In the meantime, the makers of the migraine therapies will likely have to trade discounts on their already reasonable...
3:42 PM, Sep 21, 2018  |  BioCentury | Product Development

Arrowhead refills its quiver

Arrowhead Pharmaceuticals Inc.’s tox blowup in 2016 set back its clinical timelines, but it also prompted the company to bring a more versatile platform online faster than originally planned. Early data from replacement candidates suggest...
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...