Amgen to Acquire KAI Pharmaceuticals; BASF, Catalent Enter into Bioavailability Collaboration; and More.

The European Medicines Agency (EMA) has published the final reflection paper concerning ethical and good clinical practice (GCP) aspects of clinical trials.

My network failed and I had to scrap my batch because my historian did not collect the required data. How do I upgrade the reliability of my network to maintain data continuity if my network fails again?

This month, CDER added a new program in drug safety to its "CDER World" platform for regulatory training and education.

Company makes bolt-on acquisition to enhance position in gout marketplace.

Illumina has sent a fourth letter to shareholders urging them to reject Roche's offer of $51 per share, which Illumina claims is opportunistic and undervaluing the company.

Amgen to Acquire KAI Pharmaceuticals; BASF, Catalent Enter into Bioavailability Collaboration; and More.

FDA has released a final guidance describing cGMP for preparing media fills for validation of aseptic preparations for positron emission tomography drugs.

Johnson & Johnson announced this week that Sheri S. McCoy, vice-chairman of the Executive Committee, has resigned from the company. She was considered to be in line for the CEO position.

As part of an ongoing collaboration into tabletting science, I Holland and the UK's University of Nottingham have launched a two-year programme to investigate the cause of tabletting sticking.

The management board of the European Medicines Agency has introduced a range of new measures to strengthen and extend its conflicts of interest policy for scientific-committee members and experts, as well as for members of the management board.

An initiative in the UK will pump £75 million ($120.2 million) into translational science, with the aim of transforming biological understanding into clinical impacts that will benefit patients and the UK economy.

Ranbaxy Laboratories announced that beginning in March 2012, the first shipments of atorvastatin, the generic version of Pfizer's Lipitor, had been sent to US markets from its new Mohali manufacturing facility located in Punjab, India.

On Mar. 29, 2012, the Generic Pharmaceutical Association reiterated its call for Congress to move forward with user-fee proposals for generic drugs and biosimilar products.

Amgen, AstraZeneca Agree to Codevelop Monoclonal Antibodies; Fujifilm Diosynth Biotechnologies Expands R&D Capabilities at its UK Site; and More.

A new UN organization focuses on improving the delivery of essential health supplies, promoting new technologies and products, strengthening regulatory frameworks, and enhancing financing mechanisms.

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

Critical issues that should be considered when scaling up a hot-melt extrusion process.

Collaboration can begin with a conversation.

Failure to disclose info may work sometimes, but eventually every question will be answered.

The importance of new drug trials to patients, the economy, and science.

Comparison of the top GMP deficiencies cited by the PIC/S Participating Authorities.

China's drug-distribution network has been a mess for years, but government reforms and industry focus are unveiling new opportunities for market order and growth.

The contract provider needs to know as much as the NDA holder.

The National Institute for Bioprocessing Research and Training in Ireland and Waters are partnering on training and research to increase large-molecule characterization capacity and knowledge.

On Mar. 13, 2012, FDA issued a Warning Letter to Steven Victor, CEO of IntelliCell Biosciences for a violation of the Food, Drug, and Cosmetic Act, and for violations of cGMP and Good Tissue Practice in the manufacture of its adipose tissue-derived stem-cell product.

Catalent Completes UK Expansion; Novasep Opens New Facility in China; and More.

A US court has denied AstraZeneca's request for a preliminary injunction against the FDA.