Pharmaceutical Technology Editors

FDA has released a list of its strategic priorities for the next five years to address new global challenges.

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

On Apr. 18, 2011, scientists from the national laboratories of five African nations gathered in Accra, Ghana, to take part in a week of technical training put on by the US Pharmacopeia (USP) that will teach them how to detect substandard and counterfeit medicines.

FDA Released Draft Guidance for Industry on Safety Labeling Changes.

On Tuesday, Apr. 19, 2011, officials from FDA, the US Department of Health and Human Services, and the Drug Enforcement Administration introduced President Obama?s plan for curbing prescription-drug diversion and abuse.

The implementation of digital photomicrography has expanded the capabilities of microanalysis for quality control. But if used incorrectly, the technique can hurt more than help.

We want to fill one of our oxygen-sensitive products inside an isolator system. Can we run an isolator with pure nitrogen and defined humidity?

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the April 2011 edition from ACS Valves and L.B. Bohle.

To find out how well industry is applying QbD, and what benefits the approach can bring, Equipment and Processing Report talked to Moheb M. Nasr, director of FDA?s Office of New Drug Quality Assessment.

Alynlyam forms drug-delivery pact with the University of British Columbia; Linda S. Mayer Joins Schott North America; and More.

FDA recently published guidance for preventing the cross-contamination of finished pharmaceuticals and active pharmaceutical ingredients with nonpenicillin beta-lactam antibiotics.

FDA Released Draft Guidance for Industry on Safety Labeling Changes.

New Web Search Feature on FDA.gov, Search for Product Recalls More Quickly

Johnson & Johnson has instituted a new structure for its Consumer Group according to a Reuters report.

After completing a strategic review of options for its Capsugel business, Pfizer announced on Apr. 04, 2011 that Kohlberg Kravis Roberts & Co L.P will acquire the pharmaceutical and dietary capsule company.

ATMI Forms Distribution Pact with Finesse; AAIPharma Promotes Dean Shirazi; and More.

This article, which focuses on manufacturing and drug access, is Part II of a three-part series on biopharmaceutical issues in public health, government, and developing world markets.

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

PRTM helps to improve supply-chain management and logistics in developing countries.

International Conference on Harmonization Hosts a Series of New Training Sessions

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%.

Greenstone Initiates Voluntary Recall for Possible Mislabeling; Tim McFadden Hired at Catalent; and More.

In a press release on Mar. 21, 2011, the EMA Management Board gave its approval for the current activities of former executive director Thomas Lönngren.

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.

Almac Forms an Alliance with Exco InTouch; Michael Pearson Joins Valeant; and More.

US Pharmacopeia Seeks Scientists for its 2011-2012 Fellowship Program

Last Tuesday, the US Senate approved the "America Invents Act," which is intended to reform the nation ’s patent system. If it becomes law, the bill will establish a first-to-file system by defining an invention ’s effective filing date as the actual filing date of the patent or patent application.

FDA and EMA Announce Joint Pilot Program

Epizyme signs drug-development deal with Eisai; Greg Plowman Joins Eli Lilly; and More.

Last Thursday, FDA filed a consent decree of permanent injunction against McNeil, a subsidiary of Johnson & Johnson, for failing to comply with current good manufacturing practice requirements. The action prevents McNeil from manufacturing and distributing drugs from its Fort Washington, Pennsylvania, facility until FDA determines that its operations comply with the law.