Pharmaceutical Technology Editors

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FDA Released Draft Guidance for Industry on Safety Labeling Changes.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.

Many facilities buy compressed gas tanks or evaporate liquid nitrogen to supply processes with dry, high-purity nitrogen. An in-house nitrogen generator, however, provides several significant benefits.

Growing interest in continuous drug manufacturing has brought greater attention to in-line blending, a process that the petroleum and fine-chemicals industries have used for decades.

We are making an emulsion using a high-shear in-line mixer. It?s a 60-gal batch, and it?s taking nearly an hour to get the results we?re looking for. We have tried changing the in-line mixer?s workheads to a two-stage configuration, but it doesn?t affect the mixing time. Where are we going wrong?

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the February 2011 edition from Emerson Process Management and Spirax Sarco.

WuXi and BMS Form Collaboration; F. Michael Ball Leaves Allergan for Hospira; and More.

FDA Posts PDUFA Meeting Minutes

At a conference on preserving national security at the University of Pittsburgh Medical Center last week, FDA Commissioner Margaret Hamburg stressed the importance of medical countermeasures for responding to natural and deliberate threats to public health.

The EMA has issued a statement addressing the withdrawal of the marketing authorization for Thelin, which was voluntarily withdrawn in 2010 because of a risk of serious liver injury.

The European Organization for Rare Diseases (EURORDIS), an alliance of patient organizations and individuals, celebrated its fourth Rare Disease Day on February 28.

FDA and Georgetown University Form Innovation Partnership