The QMN Weekly Bulletin

The FDA and the European Medicines Agency (EMEA) will pilot a joint GMP inspections program as a new priority under their bilateral agreement.

Leiner Health Products agreed to forfeit $10 million and plead guilty to one count of wire fraud under a proposed settlement with the Justice Department concerning charges that the firm manipulated stability data at its OTC production facility.

With the FDA anticipating publishing fiscal year (FY) 2009 drug user fees this August, the agency is asking manufacturers to update their orange book listings.

Merck for the second time in two years has expanded plans for a vaccine manufacturing plant in Durham.

Acceleron Pharma, Inc., a biopharmaceutical company developing novel therapeutics that modulate the growth of tissues including bone and muscle, announced that as part of its rapid growth and expansion it is increasing headcount by nearly 40% and doubling the size of its administrative, laboratory and manufacturing facilities in Cambridge, Mass.

SAFC Biosciences, a provider of cell culture materials and development services for the biopharmaceutical industry, said that it will collaborate with Celltrion Inc., a South Korean biopharmaceutical company and operator of Asia’s largest biopharmaceutical manufacturing facility.

Synergetics, a leading microsurgery company that designs, manufactures, and markets medical devices for use primarily in ophthalmic surgery and neurosurgery, announced that it has purchased Medimold, Inc., a Missouri based operation specializing in plastic injection molding for $80,000 in cash consideration.

PharmEng International Inc. announced that its wholly owned subsidiary, Keata Pharma Inc., is relocating contract manufacturing operations from the Perth, Ontario facility to their … pharmaceutical manufacturing facility in Sydney, Nova Scotia.

A high-technology company on Maui plans to double its work force as it manufactures and markets a new device for the pharmaceutical industry.