News

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."

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.

Senators Max Baucus (D-MT) and Chuck Grassley (R-IA) send letters to opioid manufacturers and pain groups asking them to disclose financial ties.

ICH Q11, the anticipated guideline from the International Conference on Harmonization, titled Development and Manufacture of Drug Substances, has achieved international consensus. Q11 has been one of the fastest guidelines to move through the ICH harmonization process.

The Center for Drug Evaluation and Research Ombudsman's office released its annual report detailing the common questions and complaints received by the office in 2011. A total of 461 inquiries was received, an increase of 11% from 2010. The majority of inquiries, 60%, originated from industry, with consumers accounting for 23%, healthcare providers 7%, FDA employees 5%, and other 5%.

GlaxoSmithKline tenders offer of $13.00 per share in an unsolicited bid despite an earlier rejection by Human Genome Sciences.

Coherus BioSciences, Daiichi Sankyo Form Biosimilar Pact; Sandoz Agrees to Acquire Fougera Pharmaceuticals; and More.

The European Federation of Pharmaceutical Industries and Associations has formally adopted a memorandum of understanding with key partners for a harmonized, European system for medicines verification.

Abbott Laboratories will pay $1.6 billion to settle outstanding issues concerning past sales and marketing practices for its neurologic medication, Depakote.

FDA issued a final rule on sterility testing on May 3, 2012, which amends the requirements for most licensed biological products and aims to provide manufacturers with the flexibility, as appropriate, to keep pace with technological and scientific advances. Many steps are changed or eliminated.

Sanofi has received FDA and EMA approval for expansion of fill and finish operations for alglucosidase alfa.

The UK's Medicines and Healthcare products Regulatory Agency has launched a new anticounterfeiting strategy with the aim of curbing the occurrence of falsified medicines in the county's supply chain.