Rival's claim that porcine-derived product trials took only treatment responders is "baloney," says Eurand lead investigator. read more
Two leading Republicans took aim at drug manufacturers in the opening round of the full Senate floor debate of health reform legislation. read more
Telavancin NDA for nosocomial pneumonia on hold as FDA asks for more mortality data while it assesses new requirements for HAP antibiotics. read more
Under the licensing deal, Centocor has rights to use Xencor's XmAb and Xtend technologies to develop and commercialize and antibodies. read more
FDA Inspection Of Genzyme Plant Finds Lack Of Follow-up, Old Equipment, Poor Personnel Qualification
A Form 483 posted online by FDA following a five-week inspection of the Allston Landing manufacturing plant cites 49 separate concerns. read more
Case could determine how much evidence is necessary for investors to bring a securities fraud suit to start the clock running on the statute of limitations. read more
Whoever is named to the post will be faced with changes now being debated, including an increased focus on bundled payments, that call for new demonstration projects and pilot programs to support them. read more
Approval for maintenance treatment of generalized anxiety disorder may be more about shoring up the blockbuster drug than creating a market for growth. read more
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