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Cell Therapeutics expects results to be available from its pivotal trial of
Xyotax in non-small cell lung cancer (NSCLC), known as STELLAR 3, in early-
to mid-March.
Genentech has presented final results from a long-term study that showed sustained
improvement in psoriasis symptoms throughout three years of continuous treatment
with Raptiva.
UCB Pharma has been granted a priority review for the supplemental new drug
application (sNDA) seeking approval of its leading antiepilepsy drug (AED)
Keppra as add-on therapy in children and adolescents with partial seizures
in the U.S.
The FDA has approved Medicis' Ammonul as an adjunctive therapy for the treatment
of acute hyperammonemia and associated encephalopathy in patients with deficiencies
in enzymes of the urea cycle.
Elscint has announced that Teva Pharmaceutical has exercised its option to
enter into a joint venture with Gamida-Cell, in which Elscint (through a wholly
owned subsidiary) holds 29.2 percent on a fully diluted basis, in order to
develop and commercialize StemEx for the treatment of leukemia and lymphoma.
In preparation for the new generation of molecular-based oncology medical products, the NIH's National Cancer Institute (NCI) and the FDA have announced an NCI-FDA
Research and Regulatory Review Fellowship program.
DOR BioPharma has initiated a rational drug design program to identify oral,
small molecule drugs to counter the deadly effects of Botulinum toxin exposure.
Oncolytics Biotech has received a letter of approval from the UK Medicines
and Healthcare products Regulatory Agency for its clinical trial application
to begin a Phase I clinical trial to evaluate the feasibility, safety and
antitumor effects of intratumoral administration of Reolysin in combination
with radiation in patients with advanced cancers.
Biogen Idec and Elan have announced that the Phase III Tysabri AFFIRM monotherapy
trial achieved the two-year primary endpoint of slowing the progression of disability
in patients with relapsing forms of multiple sclerosis (MS).