US and China Crack Down on Regulation after SFDA Chief Executed; Xcellerex Receives US Grant for Biopharmaceutical Production; New FDA Guidance on Polymorphic Compounds in Generic Drugs; Comment Periods Open for ICH Q10 and Biologics Guidelines

Company and People Notes: GSK Hires Jacobs Engineering Group, Agilent Exec to Retire, More.

Last week, it was reported that the US Food and Drug Administration may start outsourcing jobs to private companies.

Catalent Pharma Solutions and Danish pharmaceutical company ALK-Abelló (Hørsholm, Denmark) will substantially increase Catalent’s “Zydis” oral-dissolving tablet production capacity dedicated to ALK-Abelló’s immunotherapy products.

Pfizer (New York) proceeded with two agreements this week: a drug-development deal with Bristol-Myers Squibb (New York) and a license agreement with Xoma (Berkeley, CA) for antibody technology.

The US Food and Drug Administration is seeking public comments on a study designed to investigate the impact of visual distraction and the interplay of different sensory modalities (e.g., verbal, visual) used to present risk and benefit information during a television prescription drug advertisement.

The biopharmaceutical company Biopartners recently published data that showed its biosimilar "Valtropin" (somatropin), a recombinant human-growth hormone product, demonstrated the same safety and efficacy as Eli Lilly’s "Humatrope" in children with growth hormone deficiency.

The US Food and Drug Administration approved updated labeling for “Coumadin,” a common blood-thinning drug, that explains that patients’ genetic composition may influence their response to the drug.

August 23, 2007 Notes: AstraZeneca selects Axway's supply-chain tracking technology, Biovex names vice-president of quality assurance, more.

Amgen announced it would cut 2200–2600 jobs as part of a plan to increase operational efficiencies.

Asia–Pacific is strongly positioning itself in the global pharmaceutical market, according to a recent analysis by PricewaterhouseCoopers.

Icagen signed a worldwide collaboration and licensing agreement with Pfizer for the discovery, development, and commercialization of compounds that modulate three specific sodium ion channels and could provide treatments for pain and related disorders.

China will spend more than $1 billion to improve its food and drug safety by 2010 and give its State Food and Drug Administration more oversight powers.

Microbix Biosystems has established a team of experts to help manufacturers boost their production of influenza vaccine.

The US Food and Drug Administration announced the availability of a guidance document entitled “FDA Guidance for Industry: Exports Under the FDA Export Reform and Enhancement Act of 1996.”

Biomira Inc. and Merck KGaA update agreement, Tikvah names vice-president and CFO, more.

Senator Chuck Grassley (R-IA), a ranking member of the Senate Committee on Finance, asked the US Food and Drug Administration to explain what steps it is taking to ensure the safety of medicine manufactured outside the United States.

Schering-Plough announced today that a consent decree filed against the company in May, 2002, had been dissolved by the US District Court for the District of New Jersey in Newark.

Commissioner Andrew von Eschenbach announced that the US Food and Drug Administration will not reform its Office of Regulatory Affairs until the Working Group on Import Safety finalizes its report evaluating import safety, according to the FDA News Drug Daily Bulletin.

Abraxis acquires manufacturing facility, Genentech acquires Tanox, more.

The US House of Representatives passed legislation permitting importation of lower-cost prescription drugs from other countries, including Canada, Australia, and Europe.

GlaxoSmithKline reports that the US Department of Health and Human Services placed another order to purchase bulk H5N1 antigen for the US national stockpile of prepandemic vaccines.

Rebecca Fuller, president of BioAssist Consulting Services (Alberquerque, NM) provided an attentive audience at the 2007 Pharmaceutical Technology annual conference with a number of practical ways to apply, grow, and improve pharmaceutical manufacturing with risk management approaches.

Johnson & Johnson consolidates operations, Xceleron leases new facility, more

With more and more people in the industry sending their manufacturing processes elsewhere, it’s important to find a trustworthy contract organization and to know what to expect-and how to deal with-that organization. R. Christian Moreton, Ph.D., discussed this topic at the 2007 annual conference of Pharmaceutical Technology.

Gerry Boushelle, associate director of global supply chain clinical-supply manufacturing in Pfizer’s (New York) global research and development division, presented a case study of the company’s implementation plan, conducted during 2006, at the 2007 Pharamaceutical Technology annual conference.

A US delegation of health officials is visiting China this week on a fact-finding mission regarding food and drug safety.

Speakers introduced laser-induced breakdown spectroscopy, an analytical technique largely unfamiliar to the pharmaceutical industry, to attendees at this year’s Pharmaceutical Technology annual conference.