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IDM Pharma has submitted an electronic new drug application (NDA) to the FDA for Junovan (mifamurtide for injection), requesting approval for its use in the treatment of newly diagnosed resectable high grade osteosarcoma patients following surgical resection in combination with multiple-agent chemotherapy.
Abbott announced that the FDA has granted priority review to its recent supplemental biologics license application (sBLA) for Humira (adalimumab) as a treatment for moderately to severely active Crohn's disease.
Peregrine Pharmaceuticals has reported that patient enrollment has been completed for the company's Phase Ib repeat-dose, dose-escalation study of bavituximab in patients with chronic hepatitis C virus (HCV) infection.
Amylin Pharmaceuticals has presented Phase II data on pramlintide and announced an extensive program of clinical trials that will assess the safety and efficacy of multiple neurohormones used in combination to treat obesity.
Human Genome Sciences (HGS) announced it has received a special protocol assessment (SPA) from the FDA, agreeing on the company's Phase III clinical development program for LymphoStat-B (belimumab) in patients with active systemic lupus erythematosus (SLE).
Forest Laboratories and its development partner for desmoteplase, Paion, have announced that the steering committee of the Phase IIB/III stroke study, DIAS-2, has decided in agreement with the companies to place patient recruitment temporarily on hold until further data have been analyzed.
Renovis has announced that a pivotal Phase III study of NXY-059 (SAINT II) conducted by its exclusive licensee, AstraZeneca, did not demonstrate a statistically significant reduction on the primary endpoint of stroke-related disability in patients treated with NXY-059, as assessed versus placebo using the modified Rankin Scale.
Join FDAnews Tuesday, Oct. 31, for "Adaptive Clinical Trial Design: How to Lower Costs and Shorten Product Development Cycles." In this 90-minute interactive audioconference, Jerald S. Schindler, Dr.PH, president of Cytel Pharmaceutical Research Division, will explain how these trials can provide more information on a drug's efficacy, how they can result in a more ethical trial, how they can rescue a drug and how all this can be done without compromising the integrity of a trial. On Nov. 6, join FDAnews for "Proactive Planning for Recalls." In this 90-minute audioconference with Q&A session, 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.