A post-approval GMP inspection of Immunex of Seattle, WA, turned problems with the firm's lyophilization of Leukine (sargramostim) that the firm evidently managed to get under control inasmuch as FDA never stamped out a warning letter in connection with the audit...

Immunex, Seattle, WA, CBER Investigators Paula Trost of FDA's Seattle office and Marsha Major of the Philadelphia District needed roughly two weeks in February 1999 to comb through the Seattle-area operations of Immunex. Their audit covered the firm's producti...

Byline: Staff and Wire Services WASHINGTON - Antitrust regulators cleared the way on Friday for Amgen Inc.'s purchase of Immunex Corp., the biggest biotechnology merger ever. The Federal Trade Commission proposed an order that would allay antitrust concerns by maki...

The lack of validation for a pentose assay method was a key finding from a recent "Team Biologics" pre-approval audit of Abbott Labs' Hospital Products plant in McPherson, KS, plant. At issue was whether the assay for making Leukine (sargramostim) was validate...

Yasmin 30 (drospirenone and ethylestradiol), Schering AG's oral contraceptive, has provided significant revenue for the company since it was first approved in the USA May 2001; in 2002 the drug achieved sales of 152 million euros ($174 million) - double the previ...

AGN Stock Watch (As of August 1, 1998, 2PM) This has been a generally positive month for biotechnology stocks, especially for the ones now relatively established through strong product portfolios on the market. Companies without products generating significant ...

Definition Neutropenia is an abnormally low level of neutrophils in the blood. Neutrophils are white blood cells (WBCs) produced in the bone marrow that ingest bacteria. Neutropenia is sometimes called agranulocytosis or granulocytopenia because neutrophils make up abou...

All the various cells of the immune system are first produced in the bone marrow. Because most chemotherapeutic agents used in the treatment of cancer only kill cells which are dividing and cell division is extremely active in the bone marrow, most of this class of We...

Definition Supportive cancer therapy is the use of medicines to counteract unwanted effects of cancer treatment. Purpose Along with their beneficial effects, many cancer treatments produce uncomfortable and sometimes harmful side effects. For example, cancer drugs may c...

- Phase II Data Indicate Overall and Disease-Free Survival - ...

- EDTA removed from product - ...

Immunex Inc., Seattle, signed a three-year agreement with Voluntary Hospitals of America Supply Co., Irving, Texas, under VHA Supply's technology development program. This marks VHA Supply's fifth technology development agreement. ...

Immunex Inc., Seattle, signed a seven-year purchasing agreement with American Healthcare Systems, San Diego. The alliance also made a direct equity investment through its business development group in the company. ...

Byline: Evan Pondel Staff Writer THOUSAND OAKS - Amgen Inc. bought two of Roche's drugs for $137.5 million, the company said Wednesday, carving out a substantial foothold in Europe for the biotechnology giant. The deal parallels Immunex Corp.'s agreement last week ...

SAN ANTONIO -- COL George E. Peoples, M.D. presented positive clinical results from a HER2/neu vaccine based on an immunogenic im·mu·no·gen·ic (my-n-j peptide called E75 developed for the immunotherapy of breast cancer and other HER2/neu-expressing canc...

Abbott Labs Hospital Products Division, McPherson, KS, CBER FDA's audit of the McPherson, KS, plant operated by Abbott Labs was a preapproval review for the firm's contract production of Leukine (sargramostim), a product licensed by Immunex Seattle. Despite a ...

A sampling of advertising untitled letters issued last year by the Center for Biologics Advertising and Promotional Labeling Staff (APLS) showed the agency hitting journal ads, Web sites, press releases and other promos for referencing FDA approval, misrepresent...