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ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Patent and Trademark Office rejected the patentability of claims of a patent by Genentech that related to certain methods used to make antibodies and antibody fragments by recombinant DNA.

ePT--the Electronic Newsletter of Pharmaceutical Technology

Merck Capital Ventures, a subsidiary of Merck & Co., has invested $1.5 million to expand its service laboratory. The transaction with NanoImaging Services will add high-resolution, three-dimensional transmission electron microscope (TEM) capability, which allows biopharmaceutical researchers to see complex macromolecular structures they create with resolution as high as one nanometer.

ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration has issued generics manufacturer Vintage Pharmaceuticals a warning letter stemming from July through August 2007 that found observations pertaining to microbial contamination and failures in testing and documentation procedures.

ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration issued a draft guidance for industry titled "Good Reprint Practices" regarding the distribution of medical or scientific journal articles and reference publications that involve unapproved uses of FDA-approved drugs and medical devices.

Equipment and Processing Report

Preparing sterile products requires manufacturers to control microbial quality. Sterility and endotoxin content are critical because failure to properly manage them can seriously harm, or even kill, patients.

ePT--the Electronic Newsletter of Pharmaceutical Technology

Baxter Healthcare Corporation is providing an update to its January 2008 heparin sodium injection 1000 units/mL 10 and 30mL multi-dose vial voluntary recall of nine lots, which the company initiated as a precautionary measure due to an increase in reports of adverse reactions that may be associated with the drug.

ePT--the Electronic Newsletter of Pharmaceutical Technology

A follow-on biologics approval pathway may be on the way. US Health and Human Services Secretary Mike Leavitt accepted Sen. Charles Schumer's (D-NY) suggestion that the Food and Drug Administration and Congress work together to formulate legislation for such a pathway.

PTSM: Pharmaceutical Technology Sourcing and Management

Contract manufacturers of active pharmaceutical ingredients and intermediates unveil expansion plans and strategies at this year's Informex.

PTSM: Pharmaceutical Technology Sourcing and Management

A recent business outlook survey conducted by the Synthetic Organic Chemical Manufacturers Association reveals a generally favorable view of current and future business conditions for contract manufacturing of active pharmaceutical ingredients and intermediates.

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AIM-less

If at first the product fails, then inspect, inspect again

A wave of pharmaceutical expansions is expected in Europe this year, surprisingly by Indian companies.