Outsourcing

Genzyme (Cambridge, MA) signed a consent decree of permanent injunction that requires the company to correct manufacturing-quality violations at its Allston, Massachusetts, manufacturing facility.

Lonza Acquires MODA; Sigma-Aldrich Exec to Retire; And More.

Effective May 1, 2010, the US Pharmacopeia has revised its Pending Monographs Guideline to clarify that excipients are eligible for pending-monograph status and can ultimately be included in an official National Formulary (NF) monograph.

In an effort to standardize quality agreements for active pharmaceutical ingredients in the drug industry, the Bulk Pharmaceuticals Task Force, an affiliate of the Society of Chemical Manufacturers and Affiliates, has developed a template to help manufacturers and customers comply with US regulatory requirements in a simplified manner.

Week Of May 10, 2010: Company And People Notes: Ariad and Merck Restructure Collaboration; Genzyme Changes Leadership; and More

The biotechnology markets in the United States, Europe, and Canada, and Australia reached aggregate profitability in 2009, according to Ernst & Young.

The US Food and Drug Administration sent a letter to trade associations of manufacturers, wholesalers, and pharmacies to recommend procedures for preventing and responding to the theft of regulated products.

FDA Approves AstraZeneca's and Pozen's Vimovo; Merck Announces Management Changes; And More.

Eli Lilly faces up to the new realities of the bio/pharmaceutical industry through outsourcing.

Defining the Next Five Years.

A method for determining sample size is finally getting some respect.

FDA wants industry to talk to them about the science underlying process innovations-really.

Eli Lilly faces up to the new realities of the bio/pharmaceutical industry through outsourcing.

Chemocatalysis and biocatalysis are important elements of an effective strategy for improving yield and stereoselectivty.

The growth of Brazil's generic-drug market is on a fast track, but what are the projections for the sector's future?

A Pharma Business Imperative.

Agreement on standards for excipient qualification, development, and fair pricing is underway.

A modular approach to biopharmaceutical production could bring process flexibility, and contract manufacturing organizations are beginning to take notice.

When vessels, seals, and cooling units go haywire, operators must get in the mix.

The author describes the new IPEA excipient good-manufacturing-practice certification program that is now ANSI accredited. This article is part of a special issue on excipients and solid dosage.

Charles River Acquires WuXi AppTec; Amgen Appoints President and COO; and More.

The Society of Chemical Manufacturers and Affiliates is raising concerns over a recently introduced bill in the US Senate, which seeks to reform the Toxic Substances Control Act.

INTERPHEX 2010 will take place this week at the Jacob K. Javits Center in New York.

FDA Issues Warning Letters to Astellas, GSK, And Novartis; Sandoz Acquires Oriel Therapeutics; And More.

Cephalon Completes Acquisition of Mepha; Xcellerex Appoints President and CEO; and More.