Merck KGaA has been investing steadily in its manufacturing operations the last couple of years, and now a fill-finish plant in Italy is slated to get a €50 million infusion as Merck forges ahead in preparation for selling more biologic drugs.
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 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
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
More fill/finish trouble for Genzyme ($GENZ) at its Boston-area plant: this time, it's Fabrazyme. The production setback promises to extend an existing shortage of the Fabry disease treatment. One
Genzyme is advising U.S. doctors to prepare for a mid-April to mid-June shortage of Thyrogen. And the European Medicines Agency says Genzyme Europe BV has warned the thyroid cancer treatment will be
Genzyme ($GENZ) 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
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 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
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