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Join FDAnews Tuesday, Jan. 9, for "Pharma Marketing Laws: State by State: Strategies for Compliance with Patchwork Regulations." In this 90-minute interactive audioconference, Keith Korenchuk, attorney with Covington & Burling, will deliver clear guidance on the regulations in the three states (California, Florida and New Hampshire) that enacted new drug marketing laws in 2006, along with the states that already have drug marketing laws in place.
Vivus announced that its new drug application (NDA) for EvaMist was accepted for review by the FDA as a new treatment for vasomotor symptoms associated with menopause.
Pozen announced that the FDA has completed its initial review of the company's response to the approvable letter for Trexima sent in June, and the agency and has determined the response not yet complete.
Inex Pharmaceuticals has presented preclinical data confirming earlier studies that its proprietary lead product candidate INX-0167 provides a strong immune response that translates into a dramatic enhancement in the antitumor activity of the monoclonal antibodies Rituxan or Herceptin.
ArQule has begun dosing in its Phase I clinical trial with ARQ 171, a second-generation compound generated through its Activated Checkpoint TherapySM (ACT) program.
Seattle Genetics has announced positive data from a Phase I trial of its lead product candidate, SGN-40, demonstrating that it exhibits durable objective responses and is well-tolerated in patients with non-Hodgkin's lymphoma (NHL) who have failed multiple prior therapies.
Immtech Pharmaceuticals has initiated a Phase II trial in the U.S. of its oral drug candidate, pafuramidine maleate, as a prophylaxis to prevent malaria infections for travelers to endemic regions.
Depomed has announced statistically significant efficacy benefits of its Gabapentin GR extended-release tablets for the once-daily treatment of pain in patients with diabetic peripheral neuropathy (DPN), a nerve disorder caused by diabetes.