Analytics

The Society of Chemical Manufacturers and Affiliates (SOCMA) reported last week that the US Food and Drug Administration responded to the association's citizen petition relating to the inspection process of foreign drug-manufacturing facilities.

Company and People Notes: sanofi aventis forms pact with Micromet; Laureate Pharma adds members to its business team.

Last week, the steering committee and expert working groups of the International Conference on Harmonization (ICH) met in St. Louis, Missouri. A major success of the meeting was the adoption of several annexes to ICH Q4B on pharmacopeial texts.

A panel of industry and regulatory experts, including FDA, discuss efforts to secure the global pharmaceutical supply chain. This article contains bonus online-exclusive material.

While Congress debates hundreds of healthcare plan proposals, perhaps we, the public, can get in the game too.

The authors developed a robust, automated system to conduct Karl Fischer moisture assays for lyophilized products.

FDA's Edwin Rivera-Martinez on dodging supply-chain challenges.

The authors, representing the International Pharmaceutical Excipients Council, propose a new evaluation procedure, including tiered toxicology testing for excipients.

Editors' Picks of Pharmaceutical Science & Technology Innovations

The authors used a light-transmission-based static division system to detect particles of foreign contaminants in prefilled vials.

Also, Astellas and Medivation sign development pact; WuXi PharmaTech appoints VP of business development, more...

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

The European Fine Chemicals Group (EFCG) gave an update of some of its activities at a press conference held at CPhI Worldwide (Spain) last week, and revealed some disturbing facts regarding counterfeit APIs, which the group is particularly concerned about.

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

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.

Is the square root of (N) + 1 a statistically valid scheme?

Industry, equipment vendors, and regulators are busy refining the precision and reliability of dissolution testing.

Using handheld Raman spectroscopy, methods were developed and evaluated for 198 substances widely used as raw materials.

The nation's healtcare system needs an overhaul, but it has to be done right.

Brief pharmaceutical news items for October 2009.

The author discusses control strategies via near infrared instrumentation for continuous mixing, granulation, drying, and extrusion with a more focused detail on mixing.

USP workshop participants support new methods to safeguard heparin products but desire international harmonization. This article contains bonus online-exclusive material.

A review of NIPTE's core projects and its plans for training-and retraining-the pharmaceutical industry.

Dr Martin Cockcroft, Operations Manager at Tepnel Pharmaceutical Services, an established business of Gen-Probe Inc., speaks about harmonized microbiology methods.

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

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).

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

Company and People Notes: Neoprobe and Laureate Pharma form manufacturing agreement; Akela Pharma appoints CEO and chairman; more...