Tag:
fill finish
Latest Headlines
Latest Headlines
Genzyme's new plant to boost Fabrazyme supply
Genzyme says that, barring validation and regulatory hiccups, it expects to begin providing Fabry disease sufferers with Fabrazyme produced at its new Framingham, MA, plant beginning the first
Forecast: Pharma wants CMO consulting, regulatory support
For 2012, contract manufacturers should brace for an increase in requests for bioanalytical testing, consulting, high-potency compound and regulatory support services. But they should be able to
Fabrazyme falls victim to fill/finish
More fill/finish trouble for Genzyme ( $GENZ ) at its Boston-area plant: this time, it's Fabrazyme. The production setback promises to extend an existing shortage of the Fabry disease treatment. One
Genzyme: Fill/finish causes Thyrogen shortage
Genzyme is advising U.S. doctors to prepare for a mid-April to mid-June shortage of Thyrogen. And the European Medicines Agency says Genzyme Europe BV has warned the thyroid cancer treatment will be
Genzyme ($GENZ) swats first consent decree pitch
Genzyme ($GENZ) last week beat an end-of-November deadline for one action item dictated by its manufacturing consent decree with the FDA announced last May. It has moved the fill/finish operations of
Thyrogen on track after fill/finish revalidation
Revalidation of fill/finish equipment caused the delay in Thyrogen shipping that we reported last week , not faulty equipment. The revalidation is standard within good manufacturing practices, says
Formatech program donates fill/finish for RegeneRx's MS candidate
Formatech will donate aseptic fill and finish services for one lot of a RegeneRx Biopharmaceuticals' drug candidate to treat cardiovascular and central nervous system diseases. The donation is part
Formatech fills for Phase I Cellceutix study
Drug formulator Formatech of Andover, MA, will prep Kevetrin, a candidate for the treatment of drug-resistant cancers, for a Cellceutix Phase I study. The small-molecule substance will take the form
