Valeant Pharmaceuticals International Inc., which last year decided to pick up the brodalumab torch dropped by Amgen Inc., now faces its reckoning with the FDA. Read More
Bexion Pharmaceuticals LLC, of Covington, Ky., said the FDA cleared its application to initiate a first-in-human phase I trial with BXQ-350 for the treatment of cancer. The open-label trial will include adult patients with advanced solid tumors including glioma. Read More
Tiziana Life Sciences plc, of London, said it purchased assets from Shardna SpA, a biobanking and genomics research company located in Cagliari, Sardinia, for a total value of €258,000 (US$285,244). Read More
Poxel SA, of Lyon, France, closed a capital increase of 3.400 million new ordinary shares without preferential subscription rights reserved for a category of investors for a total amount of €26.5 million. Read More
The FDA switcheroo that's holding up Elite Pharmaceuticals Inc.'s Sequestox (oxycodone hydrochloride and naltrexone hydrochloride), the firm's abuse-deterrent opioid for pain "should not take that long" to resolve, CEO Nasrat Hakim said during a conference call intended to explain "why the FDA made that decision and how we're going to overcome it and get [the drug] approved." Read More
The drug that had so far mounted a strong defense for Roche Holdings AG's CD20-targeting franchise against the encroachment of biosimilars stumbled in a late-stage trial reported over the weekend. Read More
DURBAN, South Africa – The 21st International AIDS Conference officially kicked off Monday. But over the weekend, two days of pre-conferences have already addressed a multitude of aspects of the epidemic. Read More
DURBAN, South Africa – Name a persistent disease that is hard to detect and measure, that can come back after it looks like you've beat it, and that should be controlled by the immune system but isn't. Read More
DUBLIN – Pharming Group NV gave its weary investors a smidgen of hope Monday, with phase II trial news supporting the efficacy of its lead drug Ruconest (recombinant C1 esterase inhibitor) in treating acute attacks of hereditary angioedema (HAE). Read More
HONG KONG – A decade after the U.S. launch, Glaxosmithkline plc's (GSK) Cervarix vaccine to prevent the human papillomavirus (HPV) is in the home stretch to launch as the first HPV vaccine in Mainland China. Read More
A missed endpoint in the pivotal trial of its sole candidate sent shares of Evoke Pharma Inc. (NASDAQ:EVOK) down 73.1 percent to close at $2.89 on Monday as the company's nasal formulation of the proven diabetic gastroparesis drug metoclopramide, EVK-001, failed to achieve its primary endpoint of improving symptoms at week four of the all-female study. Read More
