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.

The US Food and Drug Administration has approved four vaccines for the H1N1 influenza virus, while other companies, including GlaxoSmithKline (GSK), have reported promising results from clinical studies with a single dose vaccine.

Speaking to the audience of the 2009 PDA-FDA Joint Regulatory Conference in Washington, DC, this week, US Food and Drug Administration Principal Deputy Commissioner outlined four principles that define FDA's role as a public health agency.

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.

Encap Drug Delivery (UK) has licensed a coating technology that targets the release of drugs to the colon.

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.