News

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.

The Society of Chemical Manufacturers and Affiliates criticized the Secure Chemical Facilities Act, which would require chemical facilities to use inherently safer technology as part of chemical-site security measures.

sanofi-aventis has gained full control over Genzyme, bringing the much talked about acquisition deal between the two companies to a close.

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

The Women in the World Summit, which was held in New York in March, focused on issues and solutions for improving the economic, political, and social rights of women globally, including a focus on global health initiatives.

Eli Lilly and GlaxoSmithKline are among several pharmaceutical companies using technology transfer as way to improve health outcomes in the developing world.

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.

Europe's approach to pharmacovigilance has room for improvement that European agencies are working on.

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.

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.

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.