Pharmaceutical Technology Editors

The US Food and Drug Administration is using prescription data from Wolters Kluwer Pharma Solutions to track the treatment of influenza A (H1N1) and other influenza viruses, according to a statement that the company released last week.

Company and People Notes: SurModics forms agreement with Roche and Genentech; Hospira names Daphne Jones senior VP and chief information officer; more...

The two agencies issued a joint Warning Letter to the owners of a website selling unapproved products intended to treat the swine flu virus.

The manufacturing process, which influences a drug's safety and efficacy, is particularly critical for drugs administered through injection, and personnel must closely supervise lyophilization to ensure product quality.

PharmTech's monthly newsletter, Equipment & Processing Report, reviews the Editor's Picks for the October 2009 edition from Emerson and Minitab.

Economic pressures are forcing pharmaceutical manufacturers to look for ways to become more competitive. Many companies realize that they must reduce operating costs but maintain or improve product quality.

For the first time, cancer treatments accounted for 5% of overall drug spending in the first half of 2009, said Medco Health Solutions in a press release last week.

Company and People Notes: Bayer Schering Pharma forms collaboration with Compugen; Takeda San Francisco appoints VP of process science; more...

Also, USAID and USP launch counterfeiting public service campaign in Cambodia.

Also, FDA partners with USDA on produce safety, and the Transparency Task Force announces its second public meeting...

The US Food and Drug Administration published its first draft guidance for industry about Risk Evaluation and Mitigation Strategies (REMS) on Sept. 30, 2009.

Company and People Notes: GSK forms joint venture with China-based Jiangsu Walvax Biotech; Sigma-Aldrich appoints VP and board member; more...

AAPS President offers hope and solutions for the industry's challenging future.

This article introduces the "Q.U.E.S.T." approach for vendor qualification, a practical and compliant methodology for pharmaceutical and biopharmaceutical companies to qualify vendors and hence make well-informed purchasing-related decisions.

The author describes the framework needed to implement QbD and achieve the deeper process understanding that is fundamental to QbD.

The author analyzes, from an agency perspective, whether question-based review has improved product quality or made the review process easier for regulators or for industry.

How manufacturers can accelerate cashflow by cutting out the paper trail.

Also, FDA bans candy and fruit-flavored cigarettes, EMEA moves to improve information management.

Company and People Notes: Boehringer Ingelheim will acquire Wyeth's animal health business; Amsterdam Molecular Therapeutics appoints CEO; more...

Rene Kummer of Sigpack Systems speaks about the company's new pharma toploader, which features an innovative box transportation unit.

Also, FDA extended the deadline for the pilot program for the submission of CMC information.

Company and People Notes: Wyeth and Ambrx form development pact; Elite Pharma appoints CEO and CSO; more...

The US Food and Drug Administration sent Bayer Schering Pharma (Berlin) a Warning Letter on Aug. 5, 2009, citing deviations from current good manufacturing practice in the manufacture of nonsterile active pharmaceutical ingredients (APIs).

Vaccine makers and other pharmaceutical manufacturers using yeast protein-expression systems are taking note of a discovery this week by a team of researchers who have found RNA interference in Saccharomyces castellii.

Also, FDA's enforcement of its rules for response times for Form 483s went into effect this week, more...

Eli Lilly and Company (Indianapolis, IN) is undergoing a companywide reorganization that is intended to accelerate the progress of the company's pipeline.

Company and People Notes: Sanofi Pasteur signs H1N1 vaccine deal with Brazilian government; Helsinn Group appoints CEO of US business; more...

PharmTech's monthly newsletter, Equipment & Processing Report, reviews the Editor's Picks for the September 2009 edition from Gore and Oystar.

Small-format packaging equipment can provide benefits to the pharmaceutical industry such as quick changeover and low tooling costs. The machines also can shorten the time it takes to bring a product to the market.

Investing time and money in auditing and optimizing a steam system can pay off quickly, especially because the costs of energy, maintenance, and downtime are steadily rising.