News

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.

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.

Feedback is urged on USP's proposed revisions to the General Notices.

By vetoing stem cell research funding, the President is vetoing potentially life-saving treatments.

Did you know that only one-third of prescribed pediatric drugs have been studied or labeled for pediatric use? The Best Pharmaceuticals for Children Act (BPCA) was enacted in 2002 to improve this statistic by providing companies with six months of additional marketing exclusivity if they conduct pediatric trials. The Government Accountability Office recently issued a report that examined data from studies conducted between 2002 and 2005 for drugs specified by the US Food and Drug Administration under BPCA.

Production sometimes follows the law of supply and reprimand.

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.

USP is revising key documents to make them easier to use.

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.