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Ziopharm Oncology has presented new data on the effect of ZIO-201 on several human pediatric sarcoma models (Ewing sarcoma, rhabdomyosarcoma, synovial sarcoma and osteosarcoma) demonstrating potent anti-cancer activity.
Metabasis Therapeutics has initiated a Phase I clinical trial of MB07811, a novel, orally active product candidate for the management of hyperlipidemia, or elevated cholesterol.
TorreyPines Therapeutics has reported findings from a Phase I clinical trial for NGX426, a novel oral therapy intended for the treatment of acute migraine and chronic pain conditions, such as neuropathic pain.
Neurogen has announced that Merck, through an affiliate, has begun a Phase II proof-of-concept clinical trial to study the investigational pain drug MK-2295 (NGD-8243).
VaxGen announced it has received a clinical hold notification from the FDA that will postpone the initiation of the company's second Phase II trial for its investigational anthrax vaccine, rPA102.
Exelixis announced that it has suspended enrollment of new patients in the XL999 clinical trial program until further data have been collected and analyzed.
Join FDAnews Monday, Nov. 6, for "Proactive Planning for Recalls." In this 90-minute interactive audioconference, noted attorney and author James M. Wood will share his proactive plan -- developed from real-world lessons he's learned during 30 years representing prescription medicine and medical device manufacturers -- on matters ranging from product recalls to off-label and liability issues. On Nov. 8, join FDAnews for "Change Control for Drugs and Biologics: Current Best Practices for FDA-Compliant Systems." In this 90-minute audioconference with Q&A session, industry expert Barbara Immel, president of Immel Resources LLC, guides you through the FDA's change control requirements for drug and biologic regulations, current FDA inspection trends and changes requiring prior FDA approval.
Bradley Pharmaceuticals announced that MediGene received FDA approval to market Polyphenon E Ointment, 15 percent, a new topical drug indicated for the treatment of external genital warts.