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Last week, FDA Commissioner Margaret A. Hamburg testified before the House Committee on Energy and Commerce, Subcommittee on Health to support the fifth authorization of the Prescription Drug User Fee Act, also known as PDUFA V. She also outlined a series of recommendations, sent to Congress in January 2012, to include in PDUFA V.

The European Commission (EC) has closed an investigation into Servier that accused the company of providing "misleading" and "incorrect" information to the EC?s pharmaceutical sector inquiry.

PhRMA announced that it will transition the management of its benefit–risk action team to the Centre for Innovation in Regulatory Science (CIRS). CIRS is a neutral, independent UK-based subsidiary company, forming part of the Intellectual Property and Science business of Thomson Reuters.

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The US Department of Justice, on behalf of FDA, filed a consent decree of permanent injunction against the generic-drug manufacturer Ranbaxy in the US District Court of Maryland. The decree was filed on Jan. 25, 2012, and is subject to court approval.

Pfizer, Sanofi, GlaxoSmithKline, and other major pharmaceutical companies have joined forces and pledged to defeat 10 neglected tropical diseases by 2020. The consortium comprises 13 pharmaceutical companies, the United States, United Kingdom, and United Arab Emirates governments, the Bill & Melinda Gates Foundation, the World Health Organization, and several other global health entities.

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The scandal surrounding Servier's diabetes drug, Mediator, continues to unravel in France and could have implications for the whole pharmaceutical industry as the country scrutinises its regulatory systems.

As the EU debates how best to spend billions of euros worth of research funding, the Humane Society International/Europe has issued a call to develop in vitro and computational techniques that can replace the use of animals in medical experiments.

According to a report from Frost & Sullivan, the European pharmaceutical contract manufacturing market could earn revenues of up to $20.75 billion in 2018, almost double that of 2011's revenue when the market earned $10.02 billion. Over the same period, the European market for biotechnology outsourcing is forecast to grow from $1.21 billion to $2.67 billion.

Constellation Pharmaceuticals announced that it has entered into a broad collaboration with Genentech, a member of the Roche group, to discover and develop innovative treatments based on epigenetics, which focuses on the identification of small molecule inhibitors of protein activity.

On Jan. 13, 2012, FDA announced it had completed, and transmitted to Congress, its recommendations for three user fee programs including the fifth authorization of the Prescription Drug User Fee Act and programs for human generic drugs and biosimilar biological products.

The generic-drugs market is poised to experience strong growth as key blockbuster products go off patent, but companies looking to benefit from this will have to be careful about the product segments where they compete, according to a report from Frost & Sullivan.

The pharmaceutical industry has a history of developing innovative medicines and novel drug-delivery systems, but not all of its manufacturing processes use cutting-edge technologies. Demands to increase productivity in fill–finish lines are fueling the arguments of proponents of robotic automation to expedite manufacturing.

I work in a quality control laboratory and use a pH meter with a single-junction reference probe to test samples taken from various pharmaceutical (drug) production lines. The probe I use has a six-month warranty. It slowly stops working after just a couple weeks. I am replacing it once a month. We make sure to store it correctly according to the manufacturer's specifications and even use probe cleaner at the end of each shift to ensure that it stays clean. What can I do to increase the lifespan to at least cover the warranty period?