Updated European guideline provides more detail on quality issues surrounding biosimilar medicines.

Catalent Expands Fill–Finish Capabilities; Siegfried Acquires Alliance Medical Products; and More.

Dr. Reddy's Laboratories and Merck Serono, a division of Merck KGaA, have partnered to codevelop a portfolio of biosimilar compounds in oncology.

In July 2012, new pharmacovigilance legislation will come into effect across the EU as a result of changes adopted in 2010, specifically EU Regulation No. 1235 and Directive 84.

Takeda Pharmaceuticals announced that it has completed the acquisition of URL Pharma for an upfront payment of $800 million.

The pharmaceutical industry weighs in on WHO global health initiatives, including R&D for diseases of the developing world, a global vaccine action plan, neglected tropical diseases, and counterfeit medicines.

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

New guide outlines potential product life-cycle approaches to the change-management system of a pharmaceutical quality system.

The United States Pharmacopeia has stated that references to General Chapter <911> "Viscosity" will be changed to General Chapter <911> "Viscosity-Capillary Viscometer Methods," <912> "Rotational Rheometer Methods," or <913> "Rolling Ball Viscometer Method."

US Pharmacopeia documents best supply-chain practices and seeks broad input on proposal.

New price-control policy has domestic and global firms waiting on the sidelines to launch products.

New coating technologies achieve high uniformity and reduce waste through mixing system advances and pan and airflow configuration.

Does global development have to entail multiple comparability studies?

Even the slightest of errors in exponential calculations can cause the biggest of headaches.

The globalisation of clinical trials is putting pressure on the European Medicines Agency.

Astra Zeneca, GlaxoSmithKline Enter into Antibiotics Pact; Takeda to Acquire Multilab; and More.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has welcomed the launch of a EUR 223.7-million ($276.5 million) program to tackle antimicrobial resistance and speed up the development of new antibiotics.

Osiris Therapeutics announced that it received marketing authorization from Health Canada to market its stem cell therapy, Prochymal, for the treatment of graft-versus-host disease in children.

Federal marshals seized an unapproved topical corticosteroid medication from California-based Crescendo Therapeutics.

The Pharmaceutical Research and Manufacturers of America and Biotechnology Industry Organization released statements last week regarding the Senate's vote to pass the Food and Drug Administration Safety and Innovation Act, which reauthorizes PDUFA.

A recent report from the UK's All Party Pharmacy Group has attributed shortages of prescription medicines in the UK to parallel trade and is calling for urgent action.

GSK Agrees to Acquire Cellzome; Patheon Restructures; and More.

The US Pharmacopeia has issued a third round of improvements to its blood thinner standard.

PDA Revises Technical Report on Sterilized Products

The Parenteral Drug Association has released guidance on the detection and mitigation of 2,4,6-tribromoanisole and 2,4,6-trichloroanisole taints and odors in pharmaceutical and healthcare products.

Human Genome Sciences rejects GlaxoSmithKline offer to acquire the company and issues a poison pill to prevent a takeover.

AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Janssen Pharmaceutica NV, Merck Serono, and Pfizer have pledged support of more than £14 million ($23 million) to a translational drug development project being run by the UK's Medical Research Council and the University of Dundee.

GSK Agrees to Acquire Cellzome; Patheon Restructures; and More.