News

The European Medicines Agency (EMEA) has issued a reminder that the Electronic Common Technical Document (e-CTD) format will be mandatory for marketing authorization applications for medicinal products for human use from 1 January 2010.

More than 80% of pharmaceutical and biologics companies are completing their postmarketing studies and regulatory obligations in a timely manner.

The European Commission (EC) has made EUR 1 billion available for new projects involving micro and nanotechnology.

The US Food and Drug Administration plans to begin collecting information for its Sentinel Initiative, according to a Sept. 4 Federal Register announcement.

Generic-drug companies are increasingly viewing the development of controlled-release formulations as a way of obtaining a competitive edge, according to a report published by Espicom Business Intelligence in late August 2009.

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

In move designed to increase its position in North America, Dainippon Sumitomo Pharma (DSP, Osaka, Japan) has agreed to acquire the specialty pharmaceutical company Sepracor (Marlborough, MA) for $2.6 billion.

Sanofi aventis has finished implementing Lanner's process simulation software into one of its major UK sites following a successful Phase I implementation in which the company made more than £1 million in inventory cost savings in 6 months.

Merck & Co. (Whitehouse Station, NJ) outlined a new organizational structure and named top management and senior leaders for the company, effective upon the completion of its merger with Schering-Plough (Kenilworth, NJ).

The US Pharmacopeial Convention (USP) and the Permanent Commission of the Pharmacopeia of the United Mexican States (FEUM) signed a memorandum of understanding (MOU) last week.

Also, Orexo and Novartis form agreement; Affitech appoints Robert Burns CEO; more...

The US Food and Drug Administration last week issued the final draft of its guidance for industry titled Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers.

Implementing Europe's Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) program, will require a massive increase in animal testing and cost six times more than previously estimated.

Also, FDA issues several recent enforcement letters to Cambrex, Johnson & Johnson, and Pedinol.

An H1N1 vaccine developed by biopharmaceutical company Sinovac Biotech (Beijing, China) has passed the experts evaluation organized by the Chinese State Food and Drug Administration (SFDA) and the company is expected to obtain a production license before the week's end.

Later this month, Dr. Barbara Jentges, the managing director at PhACT GmbH, a regulatory consulting and training firm based in Duggingen, Switzerland, will be speaking at the 2nd Vetter Drug Management Leadership Conference in Germany.

Thanks to their keen observations, these auditors reveal the true culprits of deviations.

After years of promomting QbD concepts, FDA's ready to take action on nonconformers.

An outstanding new book reviews alternative solvents with an eye to sustainable pharmaceutical processes.

A second-generation and green manufacturing process for testosterone provided economic and ecological benefits.

Personalized medicine and integrated healthcare delivery require new business and pricing models. This article contains bonus online-exclusive material.

Representatives of Japan's MHLW report on recent ICH activities and what the ministry expects from Q11.

IPEC's new stability testing guide takes into account the full supply chain's storage conditions.

The author describes several issues in creating drug master files and active substance files for active pharmaceutical ingredients and intermediates.

Designated as a "pharmerging market," Brazil is revamping its pricing models.

Jones explains how to save UK pharma.

Merger, union, alliance, partnership, collaboration: five words that ultimately suggest the strengthening of something.

Scientists at Sigma-Aldrich's new Sigma Advanced Genetic Engineering Labs in St Louis (MO, USA) will develop and distribute genetically engineered animal models for use in research.

Eastern Europe's pharmaceutical market is forecast to grow at a CAGR of more than 10% to be worth more than $41 billion by 2014, according to a report from companiesandmarkets.com.

On Aug. 19, 2009, the US Food and Drug Administration opened a new Center for Tobacco Products on the agency's White Oak Campus in Silver Spring, Maryland.