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%.

The global market for biosimilars is set to grow from $243 million in 2010 to $3.7 billion in 2015, according to research from Datamonitor, an independent industry analyst company.

AstraZeneca has been informed that the UK and US governments? tax authorities have agreed to the terms of an advance-pricing agreement regarding transfer-pricing arrangements for AstraZeneca?s US business for the 13-year period from 2002 to the end of 2014.

The National Institutes of Health?s (NIH) definition of embryonic stem (ES) cells poses new challenges for investigators who seek federal research funding.

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

Novartis has completed the acquisition of a majority stake in Zhejiang Tianyuan Bio-Pharmaceutical Co., Ltd. — one of the largest privately held vaccines companies in China.

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.

The EMA has announced a pilot program with the FDA for the parallel assessment of Quality by Design applications, as well as a separate project aimed at improving the agency?s core business.

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.

Novartis acquired a majority stake in Zhejiang Tianyuan Bio-Pharmaceutical, one of the largest privately held vaccine companies in China. The acquisition gives Novartis an expanded presence in the Chinese vaccine market and will facilitate the introduction of Novartis's vaccines into the country.

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

US Pharmacopeia Seeks Scientists for its 2011-2012 Fellowship Program

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.

FDA issued a draft guidance for industry on Mar. 11, 2011, titled User Fee Waivers, Reductions, and Refunds for Drug and Biological Products, that offers recommendations to applicants seeking such actions under the Federal Food, Drug, & Cosmetic Act (FD&C Act). A similar draft guidance was issued in July 1993. The new document clarifies the types of waivers, refunds, and reductions available under the user-fee provisions of the FD&C Act as well as the procedures for handling these requests, including how to appeal an FDA decision.

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.

Japan has suspended the use of two pediatric vaccines made by Pfizer and sanofi following the deaths of four children in three days.

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

AstraZeneca announced this week that it will discontinue the production of Pulmicort (budesonide) 100 and 200 µg/dose HFA (hydrofluoroalkane) pressurized metered-dose inhaler (pMDI) due to manufacturing issues related to technical aspects of the device, which prevents the ongoing manufacture of the product.

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.