The process-driven system reduces total cost of ownership.

Company is notified of GMP violations at facility in Catania, Italy.

Maryland is the latest state to consider whether to include additional requirements for substitution of biological products

Catalent Pharma Solutions has acquired a license to market Redwood Bioscience 's proprietary SMARTag precision protein-chemical engineering technology.

Dr. Reddy's Laboratories has announced plans to relocate its North America headquarters and establish a R&D facility in Princeton, New Jersey.

FDA Releases Guidance on Self-Selections Studies

Regeneron, a biopharmaceutical company based in New York, has announced plans to expand its corporate headquarters and laboratories in Westchester. This expansion will create more than 400 new highly skilled jobs and further cement Hudson Valley's reputation as an emerging epicenter for biopharmaceutical growth.

Company considers investment in insulin cartridge-filling and insulin API manufacturing capacity in the US.

Teva and Lonza have announced that their joint venture will continue to develop, manufacture and market affordable, efficacious and safe biosimilars.

Astellas and Ambrx have entered into a collaboration to discover and develop novel antibody drug conjugates (ADCs) for an undisclosed number of targets in oncology. ADCs enable targeted delivery of drugs to the target tissue.

USP has inaugurated the first satellite site of the USP Spectral Library Global Laboratory Network in China.

A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers.

The Access to Medicines Index shows that pharmaceutical companies are increasing drug development for the developing world and using more tiered pricing mechanisms to lower pricing.

A roundup of developments in corporate social responsibility (CSR) and sustainability from the bio/pharmaceutical industry, its suppliers, and other public and private organizations

Latin America's diverse growing market seeks regulatory harmonization.

This article summarizes the development and modernization of the United States Pharmacopeia-National Formulary (USP-NF) fixed-oil excipient monographs. This article contains bonus online-exclusive material.

A Q&A with Michael Lacey of the National Institute for Bioprocessing Research and Training

The outlook of the European biotech sector may not be as bleak as apparently believed despite the current economic climate, but compared with their US rivals, biotech companies are still struggling to attract investors and secure funding.

Novartis loses an appeal in seeking patent protection in India for its anticancer drug.

The Thai government is ramping up efforts to promote and develop the biotechnology sector in a bid to enhance its global competitiveness.

Strengthening government control or striving for compliance with international standards?

Draft guidance combines and supersedes previous guidance documents.

USP is proposing a new performance testing standard for moisture permeation of pharmaceutical packaging.

In the context of international trade, the need to develop global quality standards for medicines is increasing.

Sound policies are needed to govern the substitution of interchangeable biologics.

Conference and exhibits provide a meeting place for professionals to exchange ideas.

Latest news about compound pharmacies, biosimilars, prescription drug purchases, and other regulatory topics.

Stem cells are being developed to treat a diverse set of conditions, including spinal cord injury, amyotrophic lateral sclerosis, macular degeneration, Parkinsons disease, and Type I diabetes. But the challenges in moving from the laboratory to the clinic are formidable.