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fill finish

Latest Headlines

Latest Headlines

FDA finally lifts warning letter on AMRI fill/finish facility

When AMRI bought Hyaluron in June 2010, it enjoyed a brief, two-month honeymoon before the FDA slapped the acquired sterile syringe and vial filling plant with a warning letter. The hangover has lasted three years, but now the agency has finally issued a letter to close out the failings it found at the Burlington site.

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