Regulatory approvals for new biopharmaceuticals in the United States have nearly doubled in the past decade compared with the 1990s, says a Tufts study.

Recent recalls, including that of American Regent?s caffeine and sodium benzoate injection on May 5, 2011, highlight the importance of particulate inspection, and they might lead observers to ask whether current inspection methods are sufficiently effective.

How do you assign a minimum sample weight for a US Pharmacopeia <41> balance application when the tested repeatability gives a standard deviation of zero?

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the May 2011 edition from David Round Company and Globe Medical Tech.

Filling active ingredients directly into capsules is probably the quickest option for entering clinical trials. This case study compares manual and automated methods of capsule filling.

The Office of the United States Trade Representative issued a report as part of its annual review of the global state of intellectual-property rights protection and enforcement.

In fiscal year 2010, the number of patent settlements in which the manufacturers of branded products paid makers of generic drugs to postpone the introduction of their products reached its highest level ever, according to the Federal Trade Commission.

FDA issued a new guidance for industry concerning the submission of summary bioequivalence data for abbreviated new drug applications.

FDA is asking for input on the development of a user-fee program for biosimilar and interchangeable biological product applications.

Alkermes purchased Elan?s Elan Drug Technologies (EDT) unit in a cash and stock transaction worth approximately $960 million. The two companies will be merged into a new holding company in Ireland under the name Alkermes.

PhRMA Urges Congress to Reauthorize Legislation for Pediatric Drugs.

The IPEC is soliciting public comment about a draft plan for the independent certification of manufacturers and suppliers of pharmaceutical excipients.

Velesco partners with Vindonwestech; NeurogesX announces retirement of CEO Anthony DiTonno; and More.

A federal appeals court has lifted a ban on federal funding for embryonic stem cell research.

FDA is collecting public comments on a series of studies that the agency plans to conduct on online direct-to-consumer promotion of prescription drug products, according to an announcement in the Federal Register.

Israel-based Teva Industries seals deal to acquire Cephalon for $6.8 billion.

Volume growth in the US prescription drug market was at historically low levels in 2010, and revenue growth was anemic.

This article, which focuses on distribution and administration, is Part III of a three-part series on biopharmaceutical issues in public health, government, and developing-world markets.

A roundup of developments in corporate social responsibility and sustainability from the bio/pharmaceutical industry, its suppliers, and other public and private organizations.

GlaxoSmithKline and the Singapore Economic Development Board team in advancing sustainable pharmaceutical manufacturing.

As I strolled through Times Square, famous brand coffee cup in hand, towards the Jacob K. Javits Convention Center in New York, my thoughts were entirely focused on Interphex.

Eastern Europe's pharmaceutical leader, Hungary, is working to maintain its number-one status while also pursuing new avenues, especially in biopharmaceuticals.

Efforts are made to educate health workers in less developed countries.

Those who doubt there's faith in science, should check out our annual Bioprocessing Survey.

Can the semiconductor industry help Big Pharma develop therapies?

Monograph modernization and standards donation go hand in hand.

India has the potential to become the new star of the biotechnology industry.

Many factors affect research results.