Following a packaging error affecting birth-control pills, Pfizer has issued a one-million pack recall and warned women in the US who have been taking the medication during the last several months to consult with their physicians.

FDA Addresses the Regulation and Approval Process of PET Drugs.

GlaxoSmithKline released its fourth quarter and full year 2011 earnings report, which showed its return on R&D to be 12%-up from 11% in 2010, and closing in on the company's goal of a 14% return.

The European Medicines Agency (EMA) has published an implementation plan for Europe's new pharmacovigilance legislation, which comes into force in July with the aim of improving the safety and risk–benefit monitoring of drugs. The new legislation will represent the biggest change in the legal framework of the industry since EMA was first established in 1995.

AstraZeneca Restructures; Catalent Completes Expansion in Italy; and More.

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.

Pfizer announced a decrease in fourth-quarter revenues, but a slight increase in full-year 2011 revenues in its financial report on Jan. 31, 2012.

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.

A nickel's worth of free advice to the competition could come at the expense of your bottom line.

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.

New educational programs are key to the industry's future and to safe, available drugs.

The Asian nation is strategizing to take the lead over its regional competitors in pharmaceutical exports.

Amgen Agrees to Micromet for $1.16 Billion; Cephalon Issues Recall of Treanda; and More.

ICH Q8, Q9, and Q10 support and implications for the future.

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

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.

2012 Facility of the Year Awards are Announced; Suzhou Pharma Services Names Oliver Mueller President; and More.

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.

The EMA has released a concept paper for a guideline on pharmacogenomic methodologies in the evaluation of authorized medicines to address the fact that genetic differences can cause variability in drug therapy efficacy and safety.

Sanofi's subsidiary Genzyme has received FDA's approval for the production of Fabrazyme (agalsidase beta), used in the treatment of Fabry's disease, at its manufacturing facility in Framingham, Massachusetts. Shortages of Fabrazyme have been ongoing for the past two years.

Takeda has announced "strategic measures to achieve efficiencies for long-term growth", which includes cutting close to 3000 jobs, 2100 of which will come from Europe.

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. 11, 2012, AstraZeneca and IMS Health announced a three-year collaboration to use real-world healthcare data from Europe to inform AstraZeneca's discovery and clinical development programs.

Takeda Restructures; Savient Pharmaceuticals Names David Veitch President of Savient Europe; and More.

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.