Nanomedicines have been authorized by European licensing agencies for more than 30 years but are still posing regulatory difficulties.

The author describes how liquid chromatography-mass spectrometry works and explains some of its advantages and disadvantages, particularly compared to high-performance liquid chromatography.

The bio-pharmaceutical business outlook in South Korea remains positive.

As the Supreme Court ruled on generic-drug liability, FDA outlined new rules for warning labels.

Orphan drugs for rare diseases are a major area of investment for pharmaceutical companies, but are they becoming too expensive for Europe to afford them?

Bristol-Myers Squibb Company and Samsung BioLogics announced the companies have entered into a 10-year agreement.

A new method of vaccine design, called the Multiple Antigen Presentation System (MAPS), may result in vaccines that bring together the benefits of whole-cell and acellular or defined subunit vaccination.

Wyeth Pharmaceuticals has agreed to pay $490.9 million to resolve its criminal and civil liability arising from the unlawful marketing of the prescription drug Rapamune for uses not approved as safe and effective by FDA.

Perfecseal's high-barrier PVC-free blister-forming web, PerfecForm SkyBlue, is based on polyolefin chemistry, and its new high-barrier flow-wrap specification, PerfecPharm P232, is capable of achieving hermetic seals at the maximum speed capabilities of the top flow-wrap equipment.

Depomed, Inc. announced that FDA has accepted for filing a new drug application (NDA) from Mallinckrodt for MNK-795.

Aesica has appointed Chris Gowland as Chief Operating Officer, a new position created to further enhance the company's operational performance in APIs and formulated product manufacturing services.

Scientists at A*STAR's Genome Institute of Singapore (GIS) have identified genes that could be potential targets for anticancer agents in the treatment of aggressive breast cancer.

Kemwell Biopharma announced that it has acquired Cirrus Pharmaceuticals Inc., a contract development services company based in Research Triangle Park, N.C.

Australian team develops method for making ultrafine particles for more efficient drug delivery.

Adaptimmune has opened a Phase I/IIa ovarian cancer trial to evaluate its genetically engineered T cell treatment, with enhanced antitumor activity.

The report highlights a need for greater third party certification to ensure GMP vigilance.

The Muller Group has appointed Dr Christian Heuer as new chief operating officer of Müller AG Cleaning Solutions.

Aptuit has announced that Maurizio Denaro has assumed responsibilities as general manager of The Aptuit Center for Discovery & Development in Verona, Italy.

Galectin Therapeutics has submitted a Fast Track application to the FDA to help expedite its clinical development program.

Charles River has established partnerships with Target Health Inc. and Theorem Clinical Research Inc.

Zeiss announced the acquisition of U.S.-based Xradia, Inc.

FDA conducted a general inspection of operations and quality systems of Albany Molecular Research Inc (AMRI) in Burlington, Mass.

Abbott announces earnings per share above previous guidance range and notes increased sales in emerging markets.

Acquisition database helps extend product lifecycle by seeking new applications for drugs.

Life Technologies Corporation has filed a definitive proxy statement with the US Securities and Exchange Commission regarding Thermo Fisher Scientific Inc.

UK government review will look for unnecessary regulatory burdens and inconsistencies and at guidance clarity.

Bashir Hansraj appointed as Global Technical Director, and David Ross and Sven Thomas appointed as business development managers

Warehouse layout and personnel training are crucial to successfully implementing a warehouse management solution.