Outsourcing

Member states in the EU are working to implement the newly passed Falsified Medicines Directive.

Follow-on versions of complex biologics require extensive expertise in development and regulatory procedures.

Better strategies and practices in sourcing and procurement can contribute to the bottom line.

A recent industry survey shows keen interest in improving bioreactors and cell-culture media.

Industry struggles to curb drug abuse, diversion, and disruptions in supply.

Sometimes, there are just too many cooks in the kitchen.

FDA added a searchable database of inspection data to its website. The database lists the names and addresses of facilities that the agency inspected during fiscal years 2009 and 2010.

India's drug pricing authority increased the retail costs of certain domestically manufactured drugs, but not those of imported drug products. Pharma is asking why.

Global spending on medicines will total almost $1.1 trillion by 2015, according to an IMS Institute for Healthcare Informatics study.

The IPEC is soliciting public comment about a draft plan for the independent certification of manufacturers and suppliers of pharmaceutical excipients.

Eastern Europe's pharmaceutical leader, Hungary, is working to maintain its number-one status while also pursuing new avenues, especially in biopharmaceuticals.

Lessons from the earthquake in Japan show the vulnerability of the bio/pharma supply chain.

FDA, NIH and industry seek new strategies to spur drug development and promote access to therapies.

Many factors affect research results.

Axcan acquires Mpex Pharmaceuticals; Bend Research receives patent for improving bioavailability of low-solubility drugs; and More.

Courts and Congress seek to reshape policies and programs.

The contract-research industry in China is growing in leaps and bounds, and Big Pharma is leading the way.

PhRMA efforts of industry's R&D scientists.

Chemocatalytic and biocatalytic routes play an important role in improving the manufacture of intermediates and active pharmaceutical ingredients.

The complexity of third-party external supply networks requires new ways to manage them.

In any industry, inspections can be a pain, and pharma is no exception.

Companies engaged in global mergers and acquisitions may be hearing from the Department of Justice more often to ensure that corruptive practices are not taking place.

The need for greater process understanding raises the bar for suppliers.

Bob Weaver, president of HunterLab, discusses current trends and challenges.

On Mar. 23, 2011, sanofi-aventis offered $7 billion in notes to fund its acquisition of Genzyme. The notes are offered in six tranches scheduled to come due between 2012 and 2021, and the interest rates range from 0.05% to 4%.

Pfizer is considering divesting some of its businesses to maximize their value, according to remarks made by Mikael Dolsten, Pfizer's president of worldwide research and development, at a Barclays Capital investor conference last Thursday.

The Bulk Pharmaceutical Task Force (BPTF) of the Society for Chemical Manufacturers and Affiliates (SOCMA) and the European Fine Chemicals Group (EFCG) of the European Chemical Industry Council (CEFIC) are calling on FDA to mandate inspections of foreign active pharmaceutical ingredient (API) manufacturing sites with the cost borne by those sites being inspected. Both organizations have indicated a willingness to pay fees for these inspections when performed on their member-owned facilities that are located outside the United States.

Pfizer Completes King Acquisition; ViiV Healthcare Names Chairman; and More.

The 2011 show presents ideas for package designs and equipment options for packaging lines.

Indian manufacturers are not a near-term threat to Western CMOs, but may be long term.