Latest Headlines

Latest Headlines

Adventrx shares slip after FDA hands back NDA

Regulators have handed back Adventrx's NDA for a new formulation of Taxotere, saying the developer needs to perform a study that proves the new drug is biologically equivalent to the original. The

Facing Taxotere loss, Sanofi mulls Genzyme bid

The juxtaposition of Sanofi-Aventis headlines today is telling. On the one hand, a new court ruling virtually ensures that Sanofi's cancer drug Taxotere will face generic competition by the end of

Sanofi fights generics makers over Taxotere

Sanofi-Aventis is in court defending its blockbuster cancer drug Taxotere against generic competition. The company sued generics makers Hospira and Apotex of infringing its patents on the drug, which

New FDA reads journal reprints differently

Drugmakers may be able to tout their products with journal reprints, but even if an article supports an FDA-approved use, it could earn its distributor a kick in the pants. Poor Sanofi-Aventis got to

Deaths force halt to Cell Genesys cancer vaccine trial

A closely watched trial for Cell Genesys' prostate cancer vaccine GVAX was brought to a sudden halt after an independent monitoring committee noted a significantly higher death rate in the group

EMEA issues host of decisions

The EMEA's Committee for Medicinal Products for Human Use (CHMP) has been busy. The drug regulator released a host of decisions today, so here's the round-up: The Committee for Medicinal Products in