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2001 BW 50

SPRING 2002

THE TECH OUTLOOK


Struggling to Make It

New drugs may be more effective than ever, but they are also
hard to manufacture, as these companies can attest

NORTHFIELD LABORATORIES The FDA refused to accept a new drug application for the product in November, POLYHEME in part because it wanted more info on the (BLOOD SUBSTITUTE) manufacturing process

ENZON/SCHERING-PLOUGH The drug was introduced to the U.S. in PEG-INTRON October, and by January demand overwhelmed (HEPATITIS-C) supply, forcing Schering-Plough to create a waiting list

IDEC PHARMACEUTICALS The FDA deemed the drug approvable in January ZEVALIN but delayed the final O.K. for six weeks (NON-HODGKIN'S LYMPHOMA) because of manufacturing issues

AVIRON/AMERICAN HOME In September, the FDA requested more clinical FLUMIST and manufacturing data on the nasal spray INFLUENZA vaccine, delaying approval by at least a year

XOMA/GENENTECH In October, the drug's approval application XANELIN was delayed after manufacturing modifications PSORIASIS were made during late stage clinical trials




MARCH 3, 2002


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