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Join FDAnews Tuesday, Aug. 23, for "CDISC's Study Data Tabulation Model: Learn the Basics and Benefits of Data Standards." Experts Gary Walker and Wayne Kubick will explain what CDISC is, what the term "data standards" means, and how sponsor companies and regulatory staff can benefit from standardized data. On Aug. 30, join FDAnews for "Preparing for an FDA Preapproval Inspection." Learn how to prepare for and manage these inspections to avoid misunderstandings, prevent delays in the approval process, and eliminate unnecessary costs.
In the Aug. 17 issue of FDAnews Drug Pipeline Alert, the headline, "Crucell and DSM Will Manufacture Hepatitis C Vaccine," should have read, "Crucell and DSM Sign Research License Agreement With Chiron."
EntreMed announced the issuance of two U.S. patents covering its lead clinical-stage compound, 2- methoxyestradiol (2ME2) and multiple derivatives of 2ME2. 2ME2 (Panzem capsules and Panzem NCD) is currently in clinical trials for cancer, as well as in preclinical development for inflammatory disorders.
Genentech, Biogen Idec, and Roche have completed the filing of a supplemental biologics license application (sBLA) with the FDA for an additional indication for Rituxan (Rituximab), in previously untreated (front-line) patients with intermediate grade or aggressive, CD-20-positive, B-cell, non-Hodgkin's lymphoma (NHL) in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or other anthracycline-based chemotherapy regimens.
KV Pharmaceutical has announced that it has received notification of approvals to market Gynazole-1 from one of its international licensees, Gedeon Richter.
Debiopharm and DeveloGen have entered into a collaboration and licensing agreement, by which Debiopharm will develop PTR-262, a novel peptide drug for the treatment of myasthenia gravis (MG), before out-licensing to global partners for commercialization.
Hawaii Biotech announced that in a third study its West Nile vaccine protected 100 percent of test animals from both illness and death after six months when challenged with live West Nile Virus.
Kosan Biosciences has announced that further patient enrollment in a pair of cancer treatment clinical trials will be delayed until changes can be made to the study protocols.
YM BioSciences has announced that Health Canada has cleared a clinical trial application for a multicenter Phase I/II trial utilizing YM's anti-EGFr monoclonal antibody, nimotuzumab.