The US Food and Drug Administration plans to hold a public hearing to discuss the promotion of agency-regulated drugs and medical devices on the Internet and using social media tools, according to a notice in the Sept. 21, 2009, Federal Register.

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

A report from the European Medicines Agency (EMEA) has highlighted the critical fact that there are not enough new antibiotics in the pharmaceutical industry's pipeline to fight multidrug-resistant bacteria.

Many pharmaceutical companies in the United Kingdom are turning to basic business-skills training to help them emerge from the recession stronger than before.

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).

The current pharmaceutical model is in danger of becoming "irrelevant in the context of 21st century's global healthcare needs", according to a white paper published by global management consultancy firm A.T. Kearney.

AM Technology (UK) has joined an EU-funded project that seeks to develop flow processes for the industrial synthesis of pharmaceutical compounds.

The Senate Finance Committee through its chairman, Max Baucus (D-MT), introduced on Sept. 16, 2009, a bill, "America's Healthy Future Act of 2009," representing the latest Congressional proposal for healthcare reform.

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.

Pfizer will pay $2.3 billion to settle the investigation with the US Department of Justice regarding the off-label promotion of Bextra.

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).