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Join FDAnews Wednesday, Aug. 9, for "Strategies for Navigating New Pharma State Gift Laws." In this 90-minute interactive audioconference, Keith Korenchuk, partner with McGuireWoods, Ron Buzzeo, chief regulatory officer, Dendrite International, and Paul Silver, managing director, Huron Consulting, team up to give you strategies to navigate this new regulatory minefield. On Aug. 17, join FDAnews for "Data Monitoring Committees: Strategies for Future Trial Design." In this 90-minute audioconference with Q&A session, healthcare attorney Clint Hermes, Ropes & Gray, New York, outlines the biggest challenges in the new FDA DMC guidance and provides solutions to help prevent issues that could attract FDA scrutiny.
The FDA has approved UCB's Keppra (levetiracetam) injection of 500 mg/5 mL for use as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy.
Enzon Pharmaceuticals has initiated a Phase I clinical trial of Oncaspar to assess its safety and potential utility in the treatment of advanced solid tumors and lymphomas.
Durect has begun a trial of a new Oradur-based opioid drug candidate, the second such drug to enter clinical testing by King Pharmaceuticals, the company that will be commercializing the drug if approved, and Pain Therapeutics, the licensee of the rights to the drug and other Oradur-based products incorporating oxycodone and three other opioid compounds.
D-Pharm has completed enrolment in its Phase IIb trial of DP-b99, a neuroprotective drug that addresses several damaging processes that occur in the brains of stroke patients.
Exelixis has begun a Phase II trial of XL647, an orally bioavailable small molecule inhibitor of the HER2, EGF, VEGF and EphB4 receptor tyrosine kinases (RTKs).
MAP Pharmaceuticals has announced the initiation of a Phase II trial evaluating MAP0010, a proprietary nebulized formulation of budesonide for the inhalation treatment of asthma in pediatric and adolescent populations.