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Point Therapeutics provided an update on its clinical program, which includes two Phase III trials in Stage IIIb/IV non-small cell lung cancer (NSCLC) and a Phase II trial in Stage IV pancreatic cancer that did not meet its primary endpoint.
A leading neurology journal, The European Journal of Neurology, Feb. 28 reported a study showing that Sativex significantly reduces intractable spasticity (spasms and stiffness) in people with multiple sclerosis (MS).
Join FDAnews Wednesday, March 14, for "Strategies to Defend Against Generic Patent Challenges." In this 90-minute interactive audioconference, founder Paul Berghoff and partners Aaron Barkoff and Joshua Rich of McDonnell Boehnen Hulbert & Berghoff will present the strategies critical to your company's defense against patent challenges. On March 15, join FDAnews for "Off-Label Promotion: Prepare for Increased Enforcement." In this 90-minute audioconference with Q&A session, noted attorney Alan Minsk will describe the issues to consider when interacting with healthcare professionals and provide strategies to minimize the risk of off-label promotion violations.
The FDA has approved Abbott Laboratories' Humira to treat adult patients with moderately to severely active Crohn's disease, a chronic inflammatory disease of the intestines.
Avanir Pharmaceuticals announced it has met with the FDA to address concerns expressed in the agency's October 2006 approvable letter for Zenvia as a treatment for involuntary emotional expression disorder.
Kuros Biosurgery announced that the FDA has granted orphan drug designation to Kuros' bone-repair product, I-040302, for the treatment of solitary bone cysts.
Cytogen has announced the initiation of the first human clinical study of CYT-500, a radiolabeled monoclonal antibody that targets prostate-specific membrane antigen (PSMA).