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NeoPharm that it has met with the FDA's Office of Oncology to discuss data from the company's Phase III PRECISE trial, which evaluated cintredekin besudotox for the treatment of recurrent glioblastoma multiforme (GBM).
Baxter International announced it plans to initiate a Phase III trial of its investigational adjuvant-free pandemic H5N1 influenza vaccine to confirm the results of a Phase I/II study.
Anesiva has begun enrolling adult patients in a Phase III clinical study of Zingo, the company's fast-acting local anesthetic to treat pain associated with peripheral venous access procedures.
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.
Cephalon announced it has filed a marketing application with the European Medicines Agency (EMEA) for approval of its fentanyl effervescent buccal tablet. In the U.S., the tablet is sold under the trade name Fentora.
KAI Pharmaceuticals has announced that a Phase I/II trial evaluating KAI-9803 for reperfusion injury showed early indications that it may reduce damage to the heart and improve cardiac function in heart attack patients undergoing treatment with balloon angioplasty.
ConjuChem Biotechnologies has announced positive preliminary results from its Phase I/II multiple-dose clinical study for the treatment of Type 2 diabetes using the company's proprietary PC-DAC:Exendin-4.