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.

Clinical research organizations see reform in clinical-trial process, including the establishment of chief innovation officer at FDA.

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

It's better to catch costly mistakes in the laboratory before they reach the accounting department.

Industry leaders share their perspectives on how the pharmaceutical industry is and can further advance sustainability.

The company provides progress made in 2011 and future environmental objectives.

The Obama administration details five strategic imperatives to drive bioscience research as a means of economic growth.

Equipment design and cleaning procedures both play a role in thorough sterilization and cleaning.

At the request of FDA, the IOM prepared a report containing recommendations for how FDA might better monitor the safety of drugs after they have been approved.

Apple's experience with manufacturing facilities in China present opportunity for future best practice.

How niche strategies can offer mainstream potential for biopharmaceutical companies.

GlaxoSmithKline has partnered with the US?s Yale University to design a potential new class of medicines that could be beneficial in areas such as oncology, inflammation and infection.

Poland's government aims to make the Eastern European country a biotech powerhouse.

FDA has issued Warning Letters to 10 companies that manufacture and distribute dietary supplements that contain dimethylamylamine. FDA cited the companies for marketing the supplements without submitting evidence that the products are safe.

In a move designed to increase its international presence, Watson Pharmaceuticals has agreed to acquire Actavis for EUR 4.25 billion ($5.6 billion).

GlaxoSmithKline has reached an agreement to divest certain over-the-counter brands in selected territories to South Africa's Aspen Pharmacare Holdings for approximately $264.7 million.

AstraZeneca to Acquire Ardea Biosciences; Pfizer to Divest Nutrition Business to Nestlé; and More.

Merck KGaA has revealed further details about its previously announced restructuring program, including plans to eliminate approximately 580 jobs.

The European Commission is offering a EUR 2-million ($2.64 million) inducement prize to encourage innovation in the area of cold-chain logistics and vaccine stability.

FDA highlights success of CDER's drug-monitoring program.