News

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.

GlaxoSmithKline plans to invest more than £500 million ($798 million) in the United Kingdom across its manufacturing sites to increase production of key active ingredients for its pharmaceutical products and vaccines. The company announced selection of Ulverston in Cumbria as the location for the first new GSK manufacturing facility to be built in the UK for almost 40 years.

The European Medicines Agency has released guidance that outlines a European-wide approach for dealing with transparency and access to information included in marketing authorization applications.

Unite, Britain and Ireland's largest trade union with 1.5 million members, said it will fight the closure of Sanofi's pharmaceutical manufacturing facility in Newcastle-upon-Tyne in northeast England. Last week, Sanofi announced the closure of the facility, which employs 450 people and makes solid-dose oral drugs mainly for the UK and European markets.

The European Medicines Agency has recommended that manufacturing processes for two anticancer medicines be transferred from Ben Venue Laboratories to alternative facilities. The decision follows GMP shortcomings identified at the US-based manufacturer in late 2011, and marks the end of the EMA's review of all fourteen centrally authorized medicines that were produced at the site.

In a presentation published on FDA's website on Mar. 15, 2012, Janet Woodcock, director of CDER, outlined the current status and future plans for FDA's Sentinel Initiative, an electronic drug safety tracking system established as part of the FDA Amendments Act of 2007.

Teva Pharmaceuticals received a Warning Letter from FDA informing them that promotional materials as well as an associated webpage for Copaxone (glatiramer acetate injection) solution for subcutaneous injection were found to be false and misleading.

FDA Issues Warning Letter to Warner Chilcott; Sigma-Aldrich Expands in Asia; and More.

In our tablet coating process, we are losing up to 15% of our coating solution in each processing run. What can we do to prevent this problem in order to reduce waste and increase our cost efficiency?

Excellence United, an alliance of six specialty equipment companies, will make its first North American appearance at INTERPHEX 2012, held May 1–3 at the Javits Center in New York.

On Mar. 12, 2012, FDA released a draft guidance document for industry direct-to-consumer television advertisements that describes FDA's plans for implementing predissemination review.

The European Medicines Agency has launched a pilot program for submitting centralized marketing authorization applications electronically.