Moheb Nasr, director of the Office of New Drug Quality Assessment in the Center for Drug Evaluation and Research at the US Food and Drug Administration, addressed the agency’s history and progress in moving to a science- and risk-based approach in regulation at the Pharmaceutical Technology Annual Conference.

The US Food and Drug Administration opened for public comment its Draft Guidance for Industry, ?Cooperative Manufacturing Arrangements for Licensed Biologics.?

Rapid microbial testing in biopharmaceutical manufacturing is an important tool in potentially reducing process risk and manufacturing costs due to loss of production material. Amy McDaniel, associate director of the QC Microbial Science and Technology Department with Wyeth Biotech, discussed the company’s evaluation and implementation of rapid microbial testing at Wyeth’s facility in Andover, Massachusetts, at the Pharmaceutical Technology Annual Conference.

Adopting Lean Six Sigma practices in manufacturing and clinical development can help pharmaceutical companies cut costs and bring products to market faster, according to Carmen Medina, principal of Tunnell Consulting.

The US Food and Drug Administration’s Nanotechnology Task Force is urging the agency to develop a guidance and take steps toward addressing nanotechnology-based drugs and medical devices.

Merck & Co. acquires NovaCardia, Sanofi Pasteur completes vaccine-manufacturing facility, more

The IBM Corporation signed a $1.4-billion global outsourcing deal with AstraZeneca PLC (London). The seven-year agreement, which renews and expands on a current contract, covers the provision of IT infrastructure services to 60 countries and additional functions within AstraZeneca.

Xcellerex, Inc. received two Phase-I contracts from the Defense Advanced Research Projects Agency (Arlington, VA) for the Accelerated Manufacture of Pharmaceuticals program.

The US Food and Drug Administration announced the International Conference on Harmonization draft guidance Q10 Pharmaceutical Quality System in the Federal Register (Docket 2007D-0266, CDER 200783).

Although North America accounts for the largest share of the pharmaceutical market, Brazil, China, India, Indonesia, Mexico, Russia, and Turkey are projected to account for almost one-fifth of the global market by 2020. The rising participation in select countries' drug-development activities is evident by recent investment and outsourcing by the pharmaceutical majors.

Ventana Medical Systems, Inc.'s board of directors unanimously decided that Roche's (Basel, Switzerland) $75 per share cash offer is inadequate in multiple respects and contrary to the best interests of Ventana's stockholders.

The Bosch Group acquires Pharmatech, InterMune enters a supply agreement with Boehringer-Ingelheim, more.

The People?s Republic of China executed one of its former drug safety chiefs, Zheng Xiaoyu, for taking bribes to approve untested pharmaceuticals, including some medicines that contained fake ingredients and led to several deaths.

Novartis Vaccines plans to produce approximately 40 million doses of its ?Fluvirin? vaccine for distribution in the United States during the 2007?2008 flu season.

The United States Pharmacopeia announced that its implementation period for the USP-National Formulary General Notices statement requiring all manufacturers to conform to recently revised residual solvent standards in General Chapter 467 has been extended from July 1, 2007 to July 1, 2008.

A new guidance issued by the US Food and Drug Administration earlier this month advises companies on how to treat polymorphic drug compounds?those that exhibit multiple structural forms?in filing abbreviated new drug applications.

Albany Molecular Research acquires manufacturing sites, Bespak restructures, more

Here's a look at some of the most interesting and thematic responses you-our readers-provided for Pharmaceutical Technology's anniversary survey of industry advances and directions.

The good ol' days weren't always good.

Thirty years ago, the world was a very different place; so was the pharma industry.

Trenton, NJ (May 18)-Pharmaceutical and medical technology companies in New Jersey have found a striking disparity between six high-demand occupations and the number of qualified workers to fill those positions, according to a report issued by the HealthCare Institute of New Jersey (HINJ). Modest job growth in this field is expected for the next four years, states the report.

Akorn, Catalent, Novo Nordisk, more

Washington, DC (June 22)-Senators Orrin Hatch (R-UT), Edward Kennedy (D-MA), Michael Enzi (R-WY), and Hillary Clinton (D-NY) agreed on legislation that would authorize the US Food and Drug Administration (Rockville, MD) to approve follow-on versions of biologic therapies.

June 21 (London)-The European Medicines Agency agreed to follow up with patients affected by Roche Registration Limited's (Basel, Switzerland) "Viracept" (nelfinavir), which was recalled earlier this month. The drug, an antiretroviral medicine used to treat HIV-1 infected patients older than three years, was recalled from the European market after it was learned that some batches had become contaminated with ethyl mesilate during manufacturing.

London, UK (June 22)-The competition between biosimilars and branded drugs intensified this week thanks to favorable reviews of three biosimilar products for a popular treatment for anemia.

Double-digit growth is projected for the US generic drug market, and the industry positions for opportunities in biosimilars.

Althea Technologies partners with GeoVax Labs, Nabi Biopharmaceuticals restructures, more

Rockville, MD (June 18)-The US Food and Drug Administration, the European Commission, and the European Medicines Agency have agreed to extend cooperative activities to the areas of pediatrics and medicinal products for rare diseases (i.e., orphan drugs).