A study conducted by the European Medicines Agency (EMA) has shown that statistical methods using EMA's EudraVigilance database of adverse drug reaction reports can be used to detect drug safety issues "significantly earlier" compared with routine pharmacovigilance.

Thermo Fisher to Acquire Fermentas; Pfizer Names Head of R&D; And More.

Regulatory Roundup: USP and Russia's Roszdravnadzor Sign MOU

The US Food and Drug Administration began a partnership with the website Drugs.com to expand access to the agency's consumer-health information.

The US House of Representatives held hearings last week to gain testimony on the potential benefits and risks associated with synthetic biology and synthetic genomics.

About one month after the announcement of McNeil Consumer Healthcare's recall of children's liquid pain and allergy medications , the US Food and Drug Administration testified before the US House Committee on Oversight and Government Reform about the issue.

USP membership meeting prepared the standards-setting body to meet modern challenges.

A timely new book explains techniques for conformational analysis.

Europe moves to place excipient GMP and GDP standards on the same level as active pharmaceutical ingredients.

Despite being a historically strong performer in the pharmaceutical arena, Germany is now underperforming compared with the growth of other European markets.

Have you ever come across a new technology, process or problem in your profession and wanted to tell others or learn more about it?

Despite its potential, why is personalised medicine still not widely used in healthcare?

A collaboration involving GlaxoSmithKline and two British universities is looking to create faster acting medicines with a technology that prints APIs onto a tablet?s surface.

Bayer to Open San Francisco Innovation Hub; Lonza Bioscience Names COO; And More.

Fifty percent of the marketing authorization applications for human medicines submitted to the European Medicines Agency (EMA) in 2009 were for generic and hybrid medicines?60% higher than the agency's forecast.

FDA and NIH Launch New Safety Reporting Website; And More.

Genzyme (Cambridge, MA) signed a consent decree of permanent injunction that requires the company to correct manufacturing-quality violations at its Allston, Massachusetts, manufacturing facility.

Late last week, the US food and Drug Administration's Transparency Task Force published a series of proposals on public disclosure policies.

Signaling its interest to strengthen its presence in emerging markets, Abbott (Abbott Park, IL) has agreed to acquire Piramal Healthcare Ltd.'s (Mumbai, India) Piramal Healthcare Solutions business (domestic formulations) for $3.72 billion.

Pfizer has begun implementing the first phase of its Plant Network Strategy, which will result in the loss of approximately 6000 jobs over the next several years.

More acquisitions are expected as the patent cliff pushes the pharma industry into a critical phase, with many executives believing that the industry will be unable to innovate sufficiently from within to replace blockbuster drugs.

Lonza Acquires MODA; Sigma-Aldrich Exec to Retire; And More.

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) published its "Ten Principles on Counterfeit Medicines" last week to draw public attention to the issue.

FDA Clears Infant Rotavirus Vaccine

The US Food and Drug Administration launched a program last week designed to "educate healthcare providers about their role in ensuring that prescription drug advertising and promotion is truthful."

Pfizer (New York) announced this week plans to reconfigure its global manufacturing network as part of its integration following its $68-billion acquisition of Wyeth (Madison, NJ) in 2009.

Life-sciences companies spend proportionally more resources on information technology and get less in return on their investment than companies in other industries. The poor return on investment partly results from regulatory costs that are unique to the pharmaceutical industry, but also stems from a failure to manage data strategically.

Online process monitoring could help companies achieve the dual goals of ensuring high end-product quality and satisfying regulatory demands.