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Theqmnweeklybulletin

Aug. 17, 2007

Vol. 1 No. 8

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Merck Plans to Resume Bulk Varicella Production Soon

As Merck corrects a manufacturing error that resulted in subpotent varicella bulk ingredient for its combination measles, mumps, rubella (MMR) and chickenpox (varicella) vaccine ProQuad, the company anticipates resuming production of the bulk ingredient shortly, Merck CEO Dick Clark said during the firm’s earnings call last month. Read More

FDA Increasing Focus on Data Integrity Issues

The FDA is increasingly focusing on data integrity issues, including data manipulation, when conducting preapproval facility inspections, according to industry attorney Fredrick Branding, a partner with Reed Smith. Read More

FDA: Test ‘Worst-Case’ Version of Intervertebral Body Fusion Devices

Manufacturers of intervertebral body fusion devices containing bone-grafting material should test constructs representing the worst-case (e.g., most likely to fail) final design version, the FDA says in a recent guidance document. Read More

Detroit Pill Maker Plans to Expand, Creating 600 Jobs

Generic drug maker Caraco Pharmaceutical Laboratories Ltd. of Detroit is poised to embark on a $14.5-million expansion that will boost its pill production by 40 percent to 5 billion tablets per year, and create 600 new jobs during the next five years. Read More

Pharmatek Now Offers Contract Cytotoxic and High-Potent Analytical, Formulation and Manufacturing Services

Pharmatek Laboratories announced the addition of cytotoxic and high-potent drug development capabilities to its pharmaceutical chemistry development services. Read More

Future Lies in Service for In Vitro Diagnostic Equipment Manufacturers

Technological innovations are no longer the sole benchmark for success for manufacturers of in vitro diagnostic (IVD) equipment as additional service offerings increasingly become a hot selling point, according to “The Diagnostic Equipment Service Conundrum: How Much Is Too Much?, How Little Is Too Little?,” a new report from market research firm Kalorama Information. Read More

Jacobs Receives Contract From Pfizer for New Biotech Manufacturing Center in Ireland

Jacobs Engineering Group announced today that it received a contract from Pfizer Limited to provide construction management services for a new small-scale clinical biotech manufacturing center in Shanbally, Cork, Ireland. Read More

Nexgen Pharma Announces Acquisition of Colorado-Based Manufacturing Facility

Nexgen Pharma announces that it has acquired certain assets of The Chemins Company, Inc. located in Colorado Springs, CO. Read More

Smith & Nephew Reviews U.S. Options

Smith & Nephew, a British-based maker of orthopedic replacements, said Tuesday that manufacturing now based in Florida will be relocated or outsourced in the next two years because of cost concerns. Read More