Outsourcing

Xcelience and Penn Form Joint Venture; Almac Appoints QA Director; And More.

Last week, Senator Charles Grassley (R-IA) sent letters to 16 drugmakers, including Pfizer (New York), AstraZeneca (London), and Eli Lilly (Indianapolis), asking them about their current policies regarding whistleblowers?employees who file complaints under the False Claims Act (FCA).

Eli Lilly to Acquire Alnara Pharmaceuticals; Exelixis CEO Leaves for Biogen Idec; And More.

To continue innovating, the biopharmaceutical sector needs support from all levels.

Varley, director of commercial operations, discusses one-stop shops and timelines.

As generic divisions become the most-wanted acquisitions of Big Pharma, India's domestic industry may be thinning out.

Rising labor costs in China may result in increased competition for higher value services.

After a spate of industrial disasters, the public seeks greater oversight of corporations-so does FDA.

More information may be released to improve public understanding of regulatory policies.

Pfizer Suspends Tanezumab Program; Actavis Appoints CEO; And More.

Company and People Notes: Valeant and Biovail to Merge; GPhA Names Interim Director; And More.

GSK Acquires Laboratorios Phoenix; Catalent Makes Executive Appointments; And More.

Thermo Fisher to Acquire Fermentas; Pfizer Names Head of R&D; And More.

USP membership meeting prepared the standards-setting body to meet modern challenges.

Europe moves to place excipient GMP and GDP standards on the same level as active pharmaceutical ingredients.

Too much or too little control can actually lead to the same result.

From product development to finished patient kits, Rockwell Automation equipment is used throughout the entire process.

Bayer to Open San Francisco Innovation Hub; Lonza Bioscience Names COO; And More.

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.