News

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.

During a July 10 meeting in Lisbon, the European Medicines Agency and Heads of Medicines Agencies reviewed the achievements of the European Risk Management Strategy during 2005–2007 and the program objectives for the next two years.

Washington, DC (June 25)-More than five million US adults import prescription drugs from other countries, two million of them without an official prescription, according to a survey conducted by the Pharmaceutical Research and Manufacturers of America (PhRMA). Concerned about the number of counterfeit drugs entering the US, PhRMA launched the survey to determine who was importing prescription drugs and why.

The financial performance of the pharmaceutical majors was generally favorable through the first half of 2007, with most companies reporting moderate to double-digit growth. Industry leader Pfizer, however, reported a sales decline for the second quarter and flat revenues through the first half of 2007. Pfizer Chairman and CEO Jeffrey Kindler says the company remains committed to its plans for cost-cutting, more outsourcing, and increasing its position in biologics.

The company begins production at a new $100-million manufacturing facility for prefilled injection systems, plans further investment in packaging facilities, and targets both early-phase development and commercial manufacture.

A roundup of manufacturing and service expansions.

The latest pacts from the pharmaceutical supply chain.

A roundup of company moves and positioning from the pharmaceutical and biotechnology industries and contract service providers.

The latest on active pharmaceutical ingredients in development and under commercial manufacture

People on the move

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The US Food and Drug Administration opened for public comment its Draft Guidance for Industry, ?Cooperative Manufacturing Arrangements for Licensed Biologics.?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

Beijing Med-Pharm acquires stake in Sunstone, JHP Pharmaceuticals buys King Pharmaceuticals facility, more

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

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.