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Ariad Pharmaceuticals announced it has received feedback from the FDA regarding its special protocol assessment on the design and endpoints for its Phase III pivotal trial of oral AP23573, its novel mTOR inhibitor, in metastatic sarcoma.
Novagali Pharma has announced positive results from the Phase III clinical study of Vekacia in children suffering from vernal keratoconjunctivitis (VKC).
Join RxTrials Institute and FDAnews Tuesday, April 10, for "NIH Grants Demystified: How to Get Your Study Funded." In this 90-minute interactive audioconference, Dr. Hong Tang, a former NIH medical officer responsible for grant administration, will guide you through the labyrinth of rules and procedures that govern the three NIH grant programs. On April 12, join FDAnews for "Treatment INDs: Responding to Risks Created by Expanded Access." In this 90-minute audioconference with Q&A session, noted attorney Mark Barnes will discuss the proposed rules on expanded access and where the FDA is headed following the public comment period, as well as describe the risks and opportunities and how companies can plan for them.
Genta has filed a formal appeal of the recent decision by the FDA that the company's new drug application (NDA) for Genasense is not approvable, Genta announced.
Findings from two pivotal efficacy studies of more than 2,900 migraine sufferers demonstrated that Pozen's Trexima provided superior headache relief at two and four hours compared with placebo.
Theravance has announced the results of two studies in an ongoing Phase IIb clinical program to assess the efficacy and safety of the investigational bronchodilators GSK642444 ('444) and GSK159797 ('797), the lead long-acting Beta2 agonist (LABA) compounds being developed in the Beyond Advair collaboration with GlaxoSmithKline (GSK).