AstraZeneca is planning to outsource all drug manufacturing activities within 10 years, according to a company statement. "Manufacturing for AstraZeneca is not a core activity," said David Smith, AstraZeneca's executive vice-president of operations. "AstraZeneca is about innovation and brand-building. There are lots of people and organizations that can manufacture better than we can," Mr. Smith said.

Mr. Smith is leading restructuring initiatives in an effort to reduce costs and improve profitability before patent expirations on key drugs. According to Mr. Smith, the group plans to become strictly a research, development and marketing organization and the priority is to outsource all of the company's API manufacturing.

Celera has entered into a research collaboration with Merck to develop biomarker and pharmacogenomic tests for cancer patients. Under the terms of the agreement, Celera will evaluate certain gene expression profiles identified by Merck with the goal of developing diagnostic predictors for use in Merck's clinical trials, and to potentially form the basis for commercial diagnostic tests for oncology therapies.

Celera will receive an undisclosed payment for this collaboration and is eligible to receive an additional payment if Merck transfers a Celera validated gene expression assay to a clinical reference lab upon completion.

"This collaboration with Merck is a strong validation of Celera's diagnostic expertise in targeted medicine and our development capabilities," said Thomas White, Ph.D., chief scientific officer at Celera. "The potential outcomes from this collaboration could lead to the development of tests that may improve individualized therapy for the treatment of cancer."

The FDA has approved use of J&J's five-day, once-daily regimen of Levaquin 750 mg I.V. and oral, for the treatment of complicated urinary tract infections (cUTI) and acute pyelonephritis (AP).

The approval is based on results from a double-blind, randomized trial involving 1,109 patients with either cUTI or AP, which assessed the efficacy and safety of Levaquin versus ciprofloxacin (Cipro). Clinical success rates were similar in both treatment groups demonstrating the resolution of, or improvement in, urinary symptoms for both Levaquin and Cipro groups.

Ortho-McNeil, Inc., along with Johnson & Johnson PRD, conducted the trial and the safety profile of Levaquin is similar across doses. Levaquin is marketed by Ortho-McNeil, Inc., and PriCara, Unit of Ortho-McNeil.

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