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Aspreva Pharmaceuticals announced that patient dosing has begun in a pivotal Phase III clinical study evaluating CellCept (mycophenolate mofetil) for the treatment of lupus nephritis.
Genitope announced that its independent data safety monitoring board reviewed the first planned interim analysis of data for efficacy in its pivotal Phase III clinical trial for treatment of follicular non-Hodgkin's Lymphoma (fNHL) and recommended that the trial continue as planned.
Join FDAnews Thursday, Aug. 18, for "Cross-Labeling Combination Products:
Case Studies and Strategies for Success." David Fox and Jeffrey
Shapiro will discuss primary mode of action and cross-labeling two
of today's most divisive regulatory issues affecting combination products. On
Aug. 30, join FDAnews for "Preparing for an FDA Preapproval Inspection."
Find out how to avoid misunderstandings, prevent delays in the approval process
and eliminate unnecessary costs from David Barr, a 20-year veteran of the
FDA.
GlaxoSmithKline (GSK) and Adolor must provide additional efficacy data to the
FDA before their new drug application for gastrointestinal treatment Entereg
can be approved, the firms said recently.
Highly anticipated diabetes drug candidate Exubera, developed by Pfizer and
sanofi aventis, will be reviewed Sept. 8 by the FDA's Endocrinologic and Metabolic
Drugs Advisory Committee.
The FDA has approved an expanded indication for Shire Pharmaceuticals' Adderall
XR (amphetamine aspartate/dextroamphetamine saccharate), clearing the drug as
a once-daily treatment for adolescents aged 13 to 17 with attention-deficit/hyperactivity
disorder (ADHD).
Epimmune announced that the NIH's National Institute of Allergy and Infectious
Diseases (NIAID) now holds an active investigational new drug application from
the FDA to test Epimmune's multi-epitope recombinant protein vaccine, EP-1043,
as a component in vaccines designed to prevent HIV infection.
Vion Pharmaceuticals has initiated a Phase I/II trial of its anticancer agent
Cloretazine as a single agent in refractory or relapsed chronic lymphocytic
leukemia (CLL) and Richter's Syndrome.
Targeted Genetics announced that the preliminary results from its Phase I clinical
trial of tgAAC94 in patients with inflammatory arthritis demonstrate that the
experimental drug is well-tolerated and can be safely administered directly
into joints of patients with inflammatory arthritis.